160 Usfda Jobs

Role & responsibilities Lead and manage the Engineering department with a focus on Process Engineering and Utilities. Plan, design, and implement engineering systems to support sterile and non-sterile pharmaceutical manufacturing. Ensure uninterrupted operation and compliance of all utility systems including HVAC, WFI, clean steam, compressed air, chilled water, and effluent treatment. Develop and implement SOPs for engineering operations, preventive maintenance, and calibration. Ensure compliance with cGMP, GEP, and regulatory requirements for all engineering activities. Lead capital projects including facility upgrades, equipment installation, and utility expansions. Coordinate with QA, Production, and Validation teams for timely execution of qualification and validation activities. Monitor and control energy consumption and implement energy-saving initiatives. Ensure timely execution of preventive and breakdown maintenance for all equipment and utilities. Lead root cause analysis and implement CAPA for engineering-related deviations and failures. Ensure readiness for regulatory inspections and audits by maintaining documentation and compliance. Develop and manage engineering budgets, procurement plans, and vendor management. Lead the recruitment, training, and development of engineering personnel. Ensure safety practices are followed across all engineering operations. Drive continuous improvement initiatives in process efficiency, equipment reliability, and utility performance. Ensure timely review and approval of engineering documents including URS, DQ, IQ, OQ, PQ, and validation protocols. Should have Knowledge on TPM Principless Drive Asset Robustness Program with Energy Efficiency. Coordinate with external agencies for statutory compliance related to utilities and infrastructure. Ensure proper documentation and control of engineering records and drawings. Support technology transfer and scale-up activities from R&D to commercial production. Any other assignment given by higher management. Preferred candidate profile Educational qualification : B.E./Btech or M.E./M.Tech in Mechanical, Electrical, Chemical, or related engineering discipline. Minimum work experience: 15 to 20 years in pharmaceutical manufacturing with strong exposure to sterile operations and utility systems. Skills & attributes: Technical Skills Expertise in utility systems (HVAC, WFI, clean steam, etc.) and process equipment. Experience in project management, equipment qualification, and validation. Knowledge of regulatory requirements (USFDA, EU GMP, WHO, etc.). Familiarity with engineering documentation and QMS systems. Hands-on experience in energy management and automation systems. Behavioural skills Strong leadership and team management capabilities. Excellent problem-solving and decision-making skills. Effective communication and cross-functional collaboration. High attention to detail and commitment to compliance and safety.

Review DCS alarms. Ensure that batch charging and other manufacturing operations are strictly in accordance with the BMR/SOP and align with current GMP practices. Maintain manufacturing records online, ensuring compliance with data integrity practices. Collect samples of intermediate/in-process materials and send them to the IPQC/QC lab. Enter and verify production-related inputs in the SAP system. Review and ensure the generation of PISCADA reports. Transfer finished goods using the "Finished Goods Transfer Note." Monitor and ensure minimum stock levels of consumables, logbooks, and status labels. Ensure preventive maintenance of all equipment according to the schedule. Coordinate with service departments (QA, QC, Stores, E&M) for production-related activities. In case of any major abnormalities in the production area or activities, stop the activity immediately and inform superiors/production managers. Maintain housekeeping standards in the plant and ensure equipment cleanliness. Follow safety instructions/procedures and ensure the use of safety gear during work. Attend GMP and safety training sessions and implement the outcomes in the workplace. Conduct training for staff as a trainer. Be aware of the location and operation of firefighting equipment. Report any incidents or near misses in the MySafe portal. Rectify all safety and GMP-related observations. Do not leave the work area unattended or depart without prior permission from the manager. Manage the allocation of Isoflurane bulk to various customers. Participate in initiatives such as AET and CSR. Perform the duties of a senior in their absence or as authorized by a senior. Prepare and execute operational and performance qualification protocols. Prepare SOPs, BMRs, protocols, records, etc. Handle DocuSign and track related activities. Manage all QMS activities related to production.

Job Purpose: Maintain compliance to Quality Management System to deliver consistent quality medical devices to fulfil future strategy of Cipla. To Lead and establish Quality Management System for medical devices as per EU Regulatory requirements, CDSCO and ISO 13485 requirements and develop and implement documentation such as SOPs, Quality manual etc. to define the framework. Monitor effective implementation of Quality System across function and appraise Management Representative. Responsible for monitoring metrics/KPI for medical devices starting from design, manufacturing, postproduction. Compile data for management review meetings. Responsible for coordinating with cross functional team for internal / external audit compliance for ISO and CE marking Responsible for surveillance of regulatory guidance/ standards applicable to medical devices in the respective geographies in which Cipla products are distributed. Key Accountabilities: Develop, establish and maintain the QMS for medical devices according to EU MDR and ISO 13485 requirements. Surveillance of new/updated regulatory guidance/ ISO standards applicable to medical devices as per Ciplas product portfolio to ensure compliance to latest regulations. Surveillance of EU noncompliance reports / CDSCO / USFDA etc that are applicable to medical devices manufactured by Cipla to enable continuous improvement. Execution of Quality Management Review meeting for Medical devices and implementation of actions derived in the QMR meetings. Conduct audit of Vendors / contract manufacturers/ outsourced activities associated with medical device manufacturing/ servicing/ testing/ distribution. Ensure timely submission of quality documents to fulfil regulatory requirements. Major Activities / Tasks: Develop and establish Management responsibility system as per ISO 13485 and EU MDR Develop and establish design control system for EU market. Develop and establish key performance indicators (KPIs) for monitoring site performance and effectiveness of QMS as per ISO 13485. Prepare SOPs, Quality manual etc.as per ISO 13485/ EU MDR. Responsible to maintain compliance to ISO 13485 by adhering to SOPs and ensuring control and oversight over adherence by respective depts to SOPs. Periodic review of SOPs related to medical devices as per regulatory requirements and update. Arrange training and promote awareness among cross functional teams on ISO 13485 QMS and CE Marking Ensure readiness from QMS standpoint for internal and external audits. Provide guidance and support during internal and external audits examining compliance to EU MDR/ISO 13485 requirements. Co-ordinate with cross functional teams for internal/ external audit compliance. Create library of ISO standards. Review new/upcoming/ draft/ revised/ final regulatory guidance/ ISO standards related to medical devices applicable as per Ciplas product portfolio. Gap assessment of the guidance / standards in comparison to QMS at Cipla and identify suitable actions prior to implementation of the guidance/standard. Monitor implementation of the actions to enable continuous improvement. Schedule quality management review (QMR) meeting for medical devices. Collate data required for the QMR and prepare the presentation on site performance to monitor effectiveness of Quality management system. Appraise management representative regarding critical issues. Monitor implementation of the action plans derived from QMR by coordinating with other cross functional team. Audit of Vendors supplying Medical devices and Invitro diagnostic kits, completing audit documentation and verifying actions taken by the audited site to correct non-conformances observed. Audit of CMOs manufacturing medical devices, completing audit documentation, and verifying actions taken by the audited site to correct non-conformances observed. Audit of outsourced activities related to medical devices manufacturing/ servicing/ testing/ distribution. Coordinate with RA, QA team and Pharmaco vigilance team through emails and phone to enable timely submission of the documents. Major Challenges: Establishing Quality Management System for Medical devices according to EU MDR / ISO 13485 is new for Cipla, hence developing and maintaining it will be a challenge. Cross functional support is key in ensuring adherence to QMS, as challenge is awareness about EU/ ISO 13485 certification requirements is low in cross functional teams such as IPD/ RA/ SCM/FPS/ DSD, Marketing. Same can be overcome by promoting awareness about EU MDR/ISO 13485 requirements at the outset/ from time to time. Engage in Notified bodies audits for ISO and CE marking audits and coordinate with all Cipla teams for audit management. Coordinate with Cipla team for audit compliance. Skills & Knowledge: Educational qualifications: MSc./ MPharm/ if MTech then in Biomedical engineering; Certificate courses/diploma in ISO audits highly welcome Relevant experience: At least 9-10 years of experience in Quality of Medical Devices/IVDs /Implants Experience in regulated market product approvals e.g. US FDA is a high plus

To support and execute end-to-end regulatory documentation and review for site transfer projects, from data collation to submission. Key Responsibilities: Coordinate data collection from CFTs for pre submission and site transfer packages. Review all plant-related documents Prepare and submit dossiers for product registrations in Europe, US, UK, Canada, Australia, Brazil markets, ensuring adherence to country-specific guidelines and requirements. Prepare and maintain regulatory trackers. Support query responses and internal audits related to site transfers. Ensure documentation quality and compliance with ICH/FDA/EU/Health Canada guidelines. Qualifications: M. Pharm with 48 years of RA experience. Hands-on in Module 3, eCTD components, and lifecycle submissions. Familiarity with change management systems (Trackwise or similar).

Manager / Sr. Manager Regulatory Affairs (US Team) Reports To: Head – Regulatory Affairs Market: US and EU Location: Vadodara Job Purpose: To lead site transfer regulatory activities, ensuring timely compilation, review, and submission of ANDA variations, change controls, and query responses to health authorities like USFDA, EU and Health Canada. Responsibilities: 1. Regulatory Submissions and Approvals: Prepare Review and submit dossiers for product registrations and post approval changes in US or Europe markets, ensuring adherence to country-specific guidelines and requirements. Coordinate with internal departments (R&D, Quality Assurance, Production) to compile the necessary technical documentation for regulatory submissions. Liaise with regulatory authorities and consultants in these regions to facilitate product approvals and resolve any queries or deficiencies. 2. Compliance and Documentation: Ensure compliance with local regulatory requirements, guidelines, and international standards (such as WHO, ICH, or country-specific regulations). Maintain accurate and up-to-date records of regulatory documents, approvals, and communication. Monitor and ensure compliance with post-marketing regulatory requirements such as periodic updates, renewals and reporting obligations. 3. Labeling and Packaging Compliance: Review and approve labeling and packaging materials to ensure they meet the regulatory requirements of each country in the assigned regions. Coordinate changes in labeling as per the updated guidelines and regulations from local health authorities. 4. Product Development Support: Work closely with product development teams to ensure regulatory requirements are considered during product formulation and development. Provide regulatory advice on technical issues related to injectables, including formulation, packaging, and stability studies. 5. Regulatory Intelligence: Stay updated on changes in regulations, guidelines, and standards in the Europe, US, UK, Canada, Australia, Brazil regions. Communicate any changes or updates in regulatory requirements to relevant departments and ensure compliance with new regulations. 6. Communication and Coordination: Act as a point of contact between the company and regulatory bodies in the assigned markets. Coordinate with external partners, consultants, and distributors to facilitate regulatory submissions and product launches. 7. Cross-functional Collaboration: Collaborate with Quality Assurance, Manufacturing, and R&D teams to ensure that regulatory requirements are met at every stage of product development and manufacturing. Support in audits and inspections conducted by regulatory agencies and provide necessary documentation and information. 8. Product Registration Lifecycle Management: Manage the entire lifecycle of product registrations, including initial submissions, renewals, variations, and amendments. Ensure timely submission of regulatory documents to maintain product approvals and licenses. 9. Risk Management and Problem-Solving: Identify potential regulatory risks and devise strategies to mitigate them, ensuring uninterrupted market access for products. Provide solutions and regulatory strategies to resolve any issues or challenges related to regulatory submissions. Additional Responsibilities: Review documents, identify gaps, and guide team members on remediation. Communicate with partners and regulatory agencies for clarification and status updates. Manage timelines, risk mitigation, and submission tracking. Train and mentor junior team members. Qualifications: M. Pharm with 8–12 years in US/EU regulatory affairs. Strong understanding of CMC, change control, and Module 3. Experience in pre and/or post-approval submissions and site transfers.

Job Role: Junior/ Assistant Associates Manufacturing (Injectables) Eligibility criteria: Qualification: Any Diploma/ BSc (Full time) Years of Experience: 1 to 6 Years should be from injectable manufacturing plant. Job Description Operate production equipment such as Injectable , Sterile , Parenteral machines, Vial / Ampoule filling , Capping , Compounding , Washing ,Sealing, Terminal sterilization, Stopper process & Visual inspection. Monitor and control the production process to ensure quality products are produced within specified parameters. Maintain accurate records of production data and perform routine maintenance tasks on equipment as required. Collaborate with other team members to resolve issues and improve overall efficiency. Ensure adherence to Good Manufacturing Practices (GMP) guidelines. Must have experience with USFDA regulatory environment & process.

Job Description: Degree in mechanical engineering, electrical engineering, applied sciences or a related discipline; 10+ years of professional experience in medical device in Risk management , regulatory Quality systems EU MDR, US FDA and closely working R&D, Regulatory Affairs & design quality organizations Strong proven experience in simplifying/reviewing RMM,BRD, RMF, Trace matrix, DHFs, Design requirements, IFUs, Risk management , V&V activities etc. Expertise in interpreting & implementing various medical device standards and guidance's, such as IEC , ISO. Experience with systems for quality management, product development, and follow-up of procedures Knowledge and application of medical device QMS is required (e.g., ISO 13485, MDSAP, EU MDR, Risk Management etc.) Ensures that appropriate Quality Plans are made that include all stages product life cycle ,supports Quality Plan Validate key design inputs like : Usability, Reliability, Performance, Supportability, Manufacturability, Safety, Security, Privacy, Serviceability, Sustainability etc. Provides effective oversight of the execution of the Quality Plan, Risk Management activities, and all design related activities during the product/system life cycle Performs independent technical assessment on product quality performance and post-market product quality analysis Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required Act as a single point of contact (person assigned to project team) responsible t ensure that hardware design meets quality and compliance standards for every milestone etc.)

Description. Sr Regulatory Associate (CMC). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Primary. Job Responsibilities. Practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks (e.g., FDA, EMA). Post approval variation experience is mandatory for EU market and Preapproval MAA dosier experience for ROW is preferred.. Strong experience in preparation, compilation, review and submission of high-quality CMC dossiers for variations, renewals, annual reports, RTQs.. Can support change control assessment and impact assessments for global markets.. Capable to execute day-to-day tasks according to client processes and SOPs for building high quality global CMC dossiers.. Assists in training and mentoring of team members depending upon project requirements. Preparation, review and finalization of quality compliance reports, liaising with site, QA/ QP’s, CRAs and Client CMC team.. Ability to liaise with cross-functional teams (Quality, Manufacturing, Analytical, etc.) to gather necessary technical data and ensure regulatory consistency for global submissions.. Timely sensitization /escalation within team to maintain compliance and adherence to timelines.. Secondary. Understands Regulatory requirements for Marketing Authorization dossier applications for ROW markets.. Optional experience for tracking/ submission of regulatory/CMC commitments and update the databases. Hands on experience of RIMS/VEEVA vault.. Excellent written and verbal communication skills. Open to working in Cross-Cultural/Virtual teams. Attends client meetings as needed with relevant inputs. Good communication skills clearly articulate through emails/ calls; provide accurate update on regulatory activities for assigned products in internal or Client meetings. Qualifications. Minimum 4 years of experience required in preparation, compilation, review and submission of high-quality CMC dossiers for variations with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.. Ability to work independently and manage multiple priorities in a fast-paced consulting environment.. Detail-oriented, strong organizational skills to manage multiple priorities in a deadline-driven environment. Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

Job Description Responsible for overall engineering functions of OSD - plant Responsible for O&M of utility,HVAC, Water System and Process maintenance. Responsible for PM I Calibration I Facility maintenance and department safety functions. Responsible for regulatory I statutory audit compliance. Responsible for Preparation of maintenance reports budget and expenses control. Work Experience 20-25 years Education Graduation in Engineering or Electrical B.Tech in Engineering or Mechanical Engineering Competencies

Role & responsibilities : a. Plan, manage, and oversee the work activities of QC and Microbiology laboratories to ensure lab testing provides the highest quality analytical support for manufacturing in a timely and compliant manner, adhering to protocols, cGLP, and safety regulations. b. Manage analytical method validation of products, method transfer, stability studies, and related activities to ensure compliance with regulatory and quality standards c. Provide leadership, management, performance evaluation, and training to all laboratory employees to maintain a competent and motivated team. d. Execute and approve all laboratory operations, including reviewing and investigating any laboratory data that is outside of established trends. e. Ensure all vendors are qualified and comply with vendor qualification standards, aiming for optimal utilization of reduced testing procedures. f. Establish and implement a KPI system to ensure an optimal balance between test quality and cost efficiency. g. Collaborate closely with other departments to ensure the plant's compliance with the Quality Management System (QMS). Preferred candidate profile Candidates having experiences in Pharma formulation(OSD) of EU/USFDA plant are preferred

Role & responsibilities Review of Raw Material/Packaging Material /Stability/ Microbiology/ Cleaning Method Validation/ Validation/ Finished Product Analytical data, Certificate of Analysis & related documents. Review and approval of Exhibit Stability Protocols. Preparation and review of validation /pre-validation /commercial/annual addition batch/thermal excursion/additional study stability protocol. Approval of additional testing requests (if required). Review and approval of ln-Vitro/CU and dissolution sheets. Review and approval of Analytical Method Transfer documents. Participation in handling OOS, OOT, Investigation and deviations related to Quality Control. Review and approval of weekly and monthly software verification reports of Empower3. Periodic verification of application software on computer systems, associated with laboratory instruments with system administrator. Review of lab instruments calibration/preventive maintenance data. Review of Stability test results in NOVATEK software. Approval of Certificate of Analysis. Review and submission of analytical data to site regulatory affairs. To provide the response of regulatory affairs and Office of data reliability queries. Review and approval of change control request, specification, standard test procedure and SOP in Documentum Compliance Manager System. Preferred candidate profile Educational Qualification : B.Pharma/M.Pharma with 5 to 7 Yrs of working experience Mandatory USFDA Plant Exposure is required. Note - Sun Pharma does not seek payment of any kind from a prospective candidates for employment with Sun Pharma or authorise any agency or any individual to collect or charge any fees or charges for recruitment. Please be cautious while dealing with any recruitment agency or anyone asking you to pay money representing himself to be representing Sun Pharma.

Walk-in Interview for Zydus Lifesciences Ltd. Moraiya - Ahmedabad at Moraiya| 22nd June 2025 | We are recruiting for our Ahmedabad Units at Moraiya, Ahmedabad. Walk-in Interview Details Date : 22nd June 2025 Interview Location: Moraiya, Ahmedabad Timings: 9:00 am 3:00 pm Interview Venue: Zydus Lifesciences Limited, Moraiya Opp. Akshar industrial Park, Survey No.417,419&420, Sarkhej- Bavla N.H. No.8A, Village: Moraiya, Tal: Sanand, Dist: Ahmedabad- 382210, Gujarat, India Job Location: Ahmedabad Education Qualification: M.Sc. / M. Pharm / B. Pharm / B.sc /Diploma/ ITI Experience: 3 13 Years Production- OSD: Officer / Assistant manager : Tablet/ Capsule - Granulation, Compression, Coating, Inspection, Capsule Filling and Wurster coater. Plant Operator/ Technical Assistant : Tablet/ Capsule - Granulation, Compression, Coating, Inspection, Capsule Filling and Wurster coater. Packing: Plant operator/Technical Assistant: Blister Line(BQS), CVC Bottle Line, Sachet Packing (Wraptech) Warehouse: Officer / Sr. Executive: RM, PM, FG, Dispensing, Dispatch , Documentation Plant operator/Technical Assistant: RM, PM, Dispensing and dispatch Engineering Technician: Instrument Technician - Fitter/Electrical/Process equipments/ HVAC Operation/HVAC Validation/ Instrumentation/ Water system Quality Assurance (IPQA) Officer / Assistant Manager: IPQA in process (Mfg. and Pkg.) / QMS

Design quality engineer with minimum 10 years of experience in the medical device industry, specializing in product quality complaints management, regulatory reporting, new product design & development, and risk management. Experience in handling Medical devices including Active Devices, Software as a Medical Device, Disposables. Working on product DHF, design input, design output, product risk management, usability, verification, and validation efforts. Extensive expertise in ensuring compliance with global regulatory standards, including FDA (21 CFR Part 820) and EU MDR. Proven ability to navigate complex regulatory landscapes, secure product approvals, and facilitate successful product launches. Strong background in Biomedical Instrumentation Engineering, coupled with hands-on experience in driving cross-functional collaboration, complaint resolution, and continuous improvement initiatives. Proficient at leading complaint investigations, conducting trend analysis, and maintaining high standards of product quality and safety across the development lifecycle. Experience in DHF Gap assessments and Remediation activities. Experience in Medical Device SotA standard gap assessment for EU MDR and 510k projects. Implemented and Maintained quality systems according to ISO 13485:2016 and ISO 9001:2015. Performed Internal Quality Audits according to ISO 13485:2016 and ISO 9001:2015. Should Performed risk assessments according to ISO 14971:2019. Experience in Planning software verification and validation activities by identifying test requirements. Should have Worked on Technical documents like Trace matrix, STED, Design inputs, LRS. Should Perform Gap assessments and remediation activities for IEC 60601-1 series, IEC 62304, IEC 62366-1, ISO 11607-1, ISO 11607-2 and other medical device standards. Have knowledge in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Hands on experience in labeling activities based on ISO 20417 and ISO 15223-1.

We are looking for a highly skilled and experienced Technical Manager to join our team at Equitas Small Finance Bank. Roles and Responsibility Manage and oversee technical aspects of mortgage operations. Develop and implement process improvements to enhance efficiency and productivity. Collaborate with cross-functional teams to achieve business objectives. Analyze and resolve complex technical issues related to mortgage processing. Ensure compliance with regulatory requirements and industry standards. Provide technical guidance and support to junior team members. Job Requirements Strong understanding of technical management principles and practices. Experience working with mortgage products and services. Excellent problem-solving and analytical skills. Ability to work effectively in a fast-paced environment. Strong communication and interpersonal skills. Familiarity with industry-specific software and systems.

We are looking for a highly skilled and experienced Technical Manager to join our team at Equitas Small Finance Bank. Roles and Responsibility Manage and oversee technical aspects of mortgage operations. Develop and implement process improvements to enhance efficiency and productivity. Collaborate with cross-functional teams to achieve business objectives. Analyze and resolve complex technical issues related to mortgage processing. Ensure compliance with regulatory requirements and industry standards. Provide technical guidance and support to junior team members. Job Requirements Strong understanding of technical management principles and practices. Experience working with mortgage products and services. Excellent problem-solving and analytical skills. Ability to work effectively in a fast-paced environment. Strong communication and interpersonal skills. Familiarity with industry-specific software and systems.

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization. ",

•Direct the preparation and submission of regulatory agency applications, reports, or correspondence. •Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Required Candidate profile Experience in Regulatory Affairs function with experience in preparing DMF for US / EU / Japan / ROW market and handling their queries / deficiencies.

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Officer Onco Solid Oral Job Requisitions No : 13898 Job Description Purpose of Job Skill Required Roles and Responsibilites Qualification Required Relevant Skills / Industry Experience Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: SEZ, Ahmedabad, GJ, IN, 382213 Travel: 0% 25% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 26 May 2025

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Assistant Manager QA Job Requisitions No : 13774 Job Description Purpose of Job Responsible for overall Monitoring and Compliance of documentation and IPQA activities of DS Manufacturing related to Manufacturing facility Responsible for APQR preparation related to CI & DS, Skill Required Good Review skills with exposure of Biopharma QA Roles and Responsibilites Review of new & revised documents i-e SOP, BPCR, MPCR, PTD, TTD, Validation Protocol, Report and QRM related to BBM facility, Review and to ensure timely completion of BPCR of products (CI and DS) manufacturing in BBM for release Authorized for batch release of Critical Intermediates, Drug substance and associated in-house media, buffer and column BPCRs, Review, monitoring and follow up for timely completion of CAPA, Deviations, Change Controls, OOT, OOS, IQA/external audit observations/, etc Handling and Assessment of Breakdowns, Alarms, SAP Incidents, ERN related to BBM facility Review of electronic data/audit trail data related to BBM facility, Monitoring and participation in process validation activities of BBM Review/Approval and compilation of Process validation documentation, Monitoring and participation in cleaning validation activities of BBM Review/Approval and compilation of cleaning validation documentation, Issuance of Working Cell Bank & Master Cell Bank, EPCBs and related documentation Ensuring physical reconciliation of cell banks, Qualification Required Sc Relevant Skills / Industry Experience Good Review skills QA Biopharma experience of more than 7-8 years, Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: Biotech, Ahmedabad, GJ, IN, 382213 Travel: 0% 25% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 26 May 2025

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Officer Parenteral Job Requisitions No : 13861 Job Description Purpose of Job To supervise all activities in oncology parenteral department, Visual inspection area, external vial washing and freeze dryer technical area activities, Skill Required To supervise all activities in oncology parenteral department, Visual inspection area, external vial washing and freeze dryer technical area activities, Roles and Responsibilites To ensure cGMP compliance in the department, To ensure area, equipment and line clearance and cleaning of equipment before startup of the operation, To ensure that after completion of operation line closure activity should be performed in accordance with SOPs, To ensure that deviation, change control, CAPA is generated as and when required, To maintain the area cleanliness and arrangement before and after completion of activities, To provide technical support relating to equipment utilized in the area by repairing, maintaining and modifying production equipment utilizing technical expertise, technical manuals, precision tools and test equipment, To provide the versatility training and development of the team members, To prepare the SOPs related to area and contribute to revision of SOPs, To prepare MPCR and to ensure the production operations are followed as per the MPCR, Responsible for completion of all documentation in a timely manner and to ensure that all the Equipment log, records of housekeeping,formats and MPCRs are online, Execution of qualification activities as per qualification protocol, To ensure that production is going as per predefined schedule, To co ordinate with engineering department for normal functioning of the machine in the departments Also adhere to the preventive maintenance and calibration schedules, Any other job assigned by the superiors, In absence of said employee his/her job responsibility shall be taken care by another employee working along / under /above him/her and shall be mention in job responsibility, To ensure the compliance of EHS norms in Parenteral area, To follow ?Good Documentation Practices and Data Integrityrequirements during any GxP Operation and recording at site, To take responsibility that application of Data Integrity requirements and potential consequences for not following it are understood and followed, To review in the perspective of compliance to Data Integrity requirements while reviewing any GxP Data (Records, Reports) Specific To Job Description, To ensure that, In case of any event of potential data breach, it shall be handled through SOP on ?Handling of Potential Data Integrity Observation, To supervise all activities in oncology parenteral department, Visual inspection area, external vial washing and freeze dryer technical area activities, Qualification Required Pharmacy with reputed co Relevant Skills / Industry Experience Should have 4 5 years of experience in sterile mfg, Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: SEZ, Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 26 May 2025

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Officer Quality Control Job Requisitions No : 13777 Job Description Purpose of Job For HPLC Analysis Skill Required For Analysis of HPLC , UV, IR, Karlfisher Roles and Responsibilites For RM analysis Qualification Required SC/M Relevant Skills / Industry Experience Relevant professional / Educational background Pharmaceuticals Back ground required Any Other Requirements (If Any) Compensation / Reward Location: SEZ, Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 26 May 2025

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Senior Officer QC Micro Job Requisitions No : 13757 Job Description Purpose of Job To perform Microbiological analysis, Skill Required Microbiological skill require to perform the microbiological analysis, Roles and Responsibilites Role of microbiologist and responsibilities to perform the microbial analysis, Qualification Required Sc Relevant Skills / Industry Experience Microbiological skills required and having experience related to pharma industries, Relevant professional / Educational background Master of Science in microbiology field and having two to three years of experience, Any Other Requirements (If Any) Compensation / Reward Location: SEZ, Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 26 May 2025

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: OFFICER PACKING Job Requisitions No : 13927 Job Description Purpose of Job Skill Required Roles and Responsibilites Qualification Required Relevant Skills / Industry Experience Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: SEZ, Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 26 May 2025

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Sr Executive Quality Assurance Job Requisitions No : 13749 Job Description Purpose of Job Preparation and Review of PQR, Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software, Skill Required Having basic knowledge on Microsoft Word and Microsoft Excell Have knowledge of Minitab software for statstical evaluation of data, Roles and Responsibilites Preparation and review of PQR schedule, Planining of PQR compilation as per PQR schedule, Collection of data from all the CFT teams for compilation of PQR, Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software, Based of the PQR data recommendation to be recommended to concern department and ensure implemenation of the same, Qualification Required Pharm or M Relevant Skills / Industry Experience Should have relevant experience in Regulatory approved plant, Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: SEZ, Ahmedabad, GJ, IN, 382213 Travel: 0% 25% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 26 May 2025

Position Executive / Sr. Executive- QC Grade : A3 A4 Business Unit / Function Department - Quality Control Location Bharuch; SEZ;;;; Reports to Lab In charge-QC; Summary of Job (Purpose/ objective of the job Department Organogram to be enclosed) candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation and compliances of ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site. Key Responsibilities (Performance Indicators) Knowledge about IMS system (ISO 9001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP, USFDA, FSSC - 22000, NABL. Analytical skill for QC instrument, i.e. GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point etc. Regularize the QC activities as per cGMP requirements. RM, PKG, In-process and FG sampling and Analysis. Co-ordination with QC staff, R and D, Commercial and production for quality and dispatch related activities for on time dispatches. Day to day monitoring and execution online all IPQC and FG analysis activities. Resolve the trouble shooting related to QC activities.; Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11) Awareness about responsible care (Environment, Health, Safety and Security) No. of Reportees Qualification and Experience M.Sc. (Chemistry) with 2 - 6 yrs. Key Competencies; (Technical, Functional and Behavioral) Handling, Calibration and Hand-on experience of all QC instruments. Compliance of 21 CFR Part-11. Troubleshooting related to QC analytical instrument