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3.0 - 6.0 years
3 - 6 Lacs
Hyderabad
Work from Office
Experience : 3 to 6 Years Job Role: R&D QA Must Have Skills: Good communication skills to handle customers and clients Good to have skills: Knowledge on Deviations, change control, CAPA, market complaints, Qualifications, Validations, technology transfer documents. Job Role: Handling Day to Day QA activities in the site. Implementation of the SOPS (all departments) in the site. Preparation and review of the R&D development protocols and reports. Issuance and review of the documents to the user department. Ensure all the activities are performed as intended in the SOPS. Training to all employees and imparting training to shop floor personnel. Releasing or rejecting of raw materials and finished product. Responding to Queries from customer and Regulatory audits. Handling Deviations and change controls in the site. Monitoring and implementation of warehouse and R&D documentation activities.
Posted 1 day ago
3.0 - 8.0 years
4 - 8 Lacs
Hyderabad
Work from Office
Walk-In Drive for Development Quality Assurance - Formulation Department @ MSN R&D Center Pashamylaram on 02.08.2025 (Saturday ) Roles & Responsibilities 1. Issuing of Batch Manufacturing Records, Analytical Raw datas and maintaining the respective log books. 2. Issuing of registers and formats for all departments and maintaining of records for issuance and reconciliation. 3. Issuance approval, Issuance and Retrieval of the documents in eDMS. 4. Receiving, Issuing and reviewing the bio batches related executed Batch Manufacturing Records, Analytical raw datas and archiving. 5. Responsible for review of product development documents and analytical documents related to technology transfer. 6. Preparation and review of departmental SOPs 7. Reviewing of Equipment qualification protocols and Reports. 8. Review of supplier qualification documents. 9. Review of calibration documents 10. Receiving and reviewing of executed raw datas & ATRs and archiving for bio batches. 11. Reviewing of analytical method validation protocols & reports. 12. Maintenance, Retrieval and Archiving of all GMP related documents and records. 13. Preparation & review of department Schedules 14. Responsible for document distribution to the user departments. 15. Responsible for Document control activities. 16. Responsible for preparation, review and submitting License Applications. 17. Handling of Change controls (Permanent and Temporary), OOS and Incidents. 18. Responsible for approval of documents in absence of Head FDQA. 19. Responsible for performing job assigned by Head FDQA or his authorized designee. Note : Formulation R&D Candidates also eligible Position : Executive / Senior Executive Qualification : M Pharma / B Pharma Only. Work Location : MSN R&D Center, Pashamylaram. Department : Development Quality Assurance - Formulation Department. Experience : 2 to 8 Years Date of Interview : 02.08.2025 (Saturday ) Interview Time : 9.00 AM to 3.00 PM Venue Details : MSN Laboratories Pvt Ltd. MSN R&D center, Pashamylaram , Isnapur, Patancheru, Sangareddy - 040-30438786
Posted 2 days ago
5.0 - 8.0 years
4 - 8 Lacs
Savli
Work from Office
Implement & maintain quality systems in compliance with cGMP & regulatory norms.batch review, product release,change control,QA documentation,audits, manage deviations, CAPA,OOS investigations.quality metrics & APQR & regulatory inspection readiness.
Posted 6 days ago
12.0 - 14.0 years
8 - 9 Lacs
Udaipur
Work from Office
Responsible for overall Quality control laboratory Implementation of cGMP and good laboratory practices. Handling of laboratory incident, Out of calibration and deviation investigation. Conducted investigations on product/material test results failures and out of trends Review & approval of standard test procedure, specification Handling of laboratory incident, Out of calibration and deviation investigation. Making sure that all deviation, OOS,OOT, incident are investigated and closed before the release of the batch/material
Posted 6 days ago
10.0 - 15.0 years
7 - 9 Lacs
Nahan, Kala Amb
Work from Office
QMS, Handling Customer and Marketing Complaints, Deviations, Change Control, CAPA, Documentation, IPQA, Data control, Regulatory, Stability, SIP, BOS, GLP, Various Audit Compliance - Clients & Regulatory i.e. USFDA, GMP, ISO 22716, 9001, 45001, etc. Required Candidate profile Must have 10+ yrs of experience in Quality for 3rd Party contact Manufacturing Company. Can handle Multinational & Multi Clients for Pharma or Personal Care Products, Resolve the issues of clients.
Posted 1 week ago
1.0 - 2.0 years
4 - 8 Lacs
Ahmedabad
Work from Office
Preparing, Reviewing and Submitting Product Dossiers as per Country Specific guidelines Preparing, Reviewing and Submitting Renewal Dossiers / Variations. Responding to queries raised by Regulatory authority of respective country. Preparing CAPA reports for the audit or market complaints. Coordinating with various department for Technical Documents as DMF, Stability data, FP COA, API COA, etc. Coordinating & Arranging for the registration samples as per country guideline. Reviewing & Approving the Artworks (Text Content) Coordinating with FDCA Person for COPP & GMP and its legalization process. Updating all registration status records. Maintaining Retain Samples Records. Coordinating with customer for filing of dossier & getting it timely approval. SKILLS: Fluent in English. Good communication skills. Ability to work under pressure and to meet deadlines.
Posted 1 week ago
4.0 - 8.0 years
4 - 9 Lacs
Ahmedabad
Work from Office
Greetings from Zydus! We have an exciting opportunity for candidates who have experience in Market Complaints. Department: Packing Role: Market Complaint / Investigation Location : Ahmedabad Interested candidates are requested to send their CV on vaibhavi.harish2@zyduslife.com or whatsapp on 6358958368.
Posted 1 week ago
8.0 - 12.0 years
0 Lacs
gujarat
On-site
As a Supervisor at Sigachi located in Dahej, you will play a crucial role in ensuring the smooth production operations in line with GMP standards. Sigachi, a renowned manufacturer of Excipients for Pharma, Nutra, and food industries, has been a key player in the market since its inception in 1989. With multiple facilities in Telangana and Gujarat, Sigachi has solidified its position as a leading producer of Microcrystalline Cellulose globally. Operating under various certifications like EXCiPACT GMP, SGMP, HACCP, EDQM CEP, and ISO 9001:2015, Sigachi has built a reputation for delivering high-quality products across continents. Your primary responsibilities will include planning and organizing production schedules to meet targets for output, quality, and yield. You will oversee all production operations to ensure compliance with SOPs and GMP standards. Collaborating closely with the Quality Control department, you will focus on continuous improvement and effective resource utilization to maintain quality parameters. Additionally, you will coordinate with cross-functional teams, particularly the Engineering Department, to ensure the production of top-notch quality products. It will be your duty to provide on-the-job training for production staff and maintain updated training records. You will be responsible for reporting deviations, conducting investigations, and implementing corrective and preventive actions as necessary. Moreover, your role will involve coordinating with QA for batch release, investigating non-conforming batches, and ensuring batch identification and traceability. Maintaining equipment/instruments calibration, practicing good housekeeping, and adhering to gowning procedures are also part of your responsibilities. In terms of qualifications, we are looking for candidates preferably with a B.Sc, M.Sc, B.Pharm, M.Pharm, or B.Tech (Chemical) degree. An experience of 8 - 10 years in the Pharma Industry or Excipient Manufacturing sector will be highly advantageous for this role. If you are a self-driven professional with a keen eye for detail and a strong background in production operations, this position at Sigachi offers a challenging yet rewarding opportunity to showcase your expertise and contribute to the company's commitment to excellence.,
Posted 1 week ago
8.0 - 10.0 years
8 - 10 Lacs
Manesar
Work from Office
Role & responsibilities Leads and optimizes QA function that supports organizations QMS in compliance with respective international regulatory requirements. • Hosting and support in external/client audits and regulatory inspections hosted by Auriga. • Audits and inspection handling. • Conduct internal system and process audits within Auriga systems. • Conduct external audits including the audit of vendors, clients and/or clients business partners and service providers. • Lead and manage a team of clinical audit professionals, providing guidance, training, and mentorship. • Support the operations team for adequate root cause identification, conducting gap analysis and implementation of corrective action plan. • Participate in risk assessments and preparation of risk-based audit plan for auditing internal processes, vendors and customers. • Supporting the CAPA management in audit and Inspection related CAPAs. • Support the document life cycle management, deviation handling process and change control process. • Prepare audit reports to communicate outcomes of quality review activities. • Preparation and or/review of company standard operating procedures (SOPs) and such other quality documents. • Interpret and implement quality assurance standards within the organization. • Liaise with quality representatives, internal customers and external customers across Auriga global access offices as required to achieve quality objectives. • Ensure development and maintenance of a PV Quality System for Standard Operating Procedures, auditing, review CAPAs, Change control and deviations. • Evaluate client audit and regulatory inspection findings and prepare and distributes reports to observation staff, management and customers.
Posted 1 week ago
4.0 - 6.0 years
4 - 6 Lacs
Jammu
Work from Office
QMS documentation, handling change control, incident, deviation, OOS,OOT,CAPA; preparing and reviewing BPR, BMR, SOP, STP, COA & other protocols; handling market complaints; process validation.
Posted 1 week ago
2.0 - 7.0 years
3 - 7 Lacs
Tirupati
Work from Office
Role & responsibilities Audit Trail Review Batch Release Method Validation & Transfer Review Calibration Records Review Analytical Raw Data Issuance OOS, Lab Deviation CAPA QC Review Experience in handling audits Preferred candidate profile Should have participated in Audits and exposure towards it Should be qualified in Chemistry knowledge in process and production Smart enough to understand the regulatory requirements Knowledge in regulatory and GMP. Perks and benefits As per Company norms
Posted 2 weeks ago
15.0 - 18.0 years
15 - 17 Lacs
Navsari
Work from Office
Role & responsibilities Responsible for defining QA strategy, approach and execution in the field of document control, IPQA, qualification/validation, GLP, training activities etc. and responsible for leading and directing QA team To approve SMF, VMP, quality manual and validation protocol. To conduct internal audit / self-inspection to ensure compliance to GMP and another regulatory requirement. To arrange management review meeting and escalate the outcome of quarterly report to management. To handle the Market Complaints and to participate in Product Recall. To approve quality system documents likes Change controls proposals, Deviations, Incident reports, CAPA reports, OOS and OOT, NCR, Market Complaints, product recalls and Returned goods. Responsible for review and approval of new as well as revised related Specification, Standard Test Procedure and Analytical Work Record. Responsible to design validation/ qualification strategies Responsible for validation /qualification of processing equipments, cleaning equipments and testing equipments on time. Responsible for day-to-day validation planning and execution activity. Responsible to approve specifications, standard test procedures and analytical work records. To approve quality management system documents i.e. change controls, deviations, incident reports, out of specifications, out of trends, non-conformance reports, market complaints, product recalls, returned goods, corrective and preventive action reports. Responsible for regulatory & customer audits preparation, execution and its compliance. To approve and authorize technical agreements from customer and outside party. Responsible to coordinate with regulatory department for submission of dossiers and documents to regulatory department. Responsible to make the management aware of any deviation/non-compliance or any other quality related issues during validation/ qualification & processing. To ensure the implementation of quality risk management procedures. Responsible to finalize training topics as per requirement and organize annual training plan with Training coordinator on cGMP and technical aspects. To ensure that processes needed for the Quality Management System are established, implemented and maintained. Responsible for investigation & review of non-conforming events including customer complaints and internal non-conforming events. Responsible for report, review, evaluation and tracking of change control, deviation, incident, market complaint, non-conformance report, product recall, corrective and preventive action. Responsible to ensure that a document control procedure is adopted to approve, review and update all changes to critical documents within the scope of Quality Management System. Responsible to perform vendor audits and internal audits. To check audit trial and back-up verification documents. Participation in study raised through Quality Management System.
Posted 2 weeks ago
15.0 - 20.0 years
20 - 25 Lacs
Pune
Work from Office
Position: Site Head (Sr. Manager) - Production Location: Ranjangaon, Near Pune Reporting To: Head - Manufacturing Operations Industry: Pharmaceutical Manufacturing Experience: 15+ years in Plant leadership roles, preferably in pharmaceutical or manufacturing industries About Fresenius Kabi At Fresenius Kabi, we are driven by a commitment to improve the quality of lives: We are Committed to life. We strive for continuous innovation with our outstanding manufacturing capabilities, unique channel access, and customer proximity. With our four complementary business areas BioPharma, Pharma (primarily IV drugs and infusion therapy), Medical Nutrition, and MedTech; Fresenius Kabi plays a vital role in the treatment of chronically and critically ill patients across various healthcare settings. For instance, over 70% of our IV drug units shipped in the US are on the Essential Medicines List of the US Food and Drug Administration, emphasizing the importance and impact of our products. All meaningful care comes down to people with the experience, expertise, and compassion to make a difference in the lives of those facing challenging situations. For us, care is a fundamental obligation, mission, and daily source of inspiration. It is the momentum that pushes us forward to help elevate the quality of life for both caregivers and those who need it most: critically and chronically ill patients. By providing essential medicines and technologies for infusion, transfusion, and medical nutrition, we are helping advance the future of healthcare, making it even more accessible, reliable, and in tune with current and future needs. Our principles: The Fresenius Principles form the basis of our company culture, with which we support our #FutureFresenius strategy. They describe what we stand for and how we operate, collaborate, approach challenges and make decisions as individual Fresenius employees and as a whole team. Role & responsibilities Confirm that production is carried out by appropriately qualified, experienced, and trained personnel. Ensure GMP-compliant operations across all manufacturing activities. Verify that manufacturing operations are clearly defined, systematically reviewed, and proven capable of consistently producing products of the required quality. Ensure manufacturing processes are properly validated. Provide assurance that critical process parameters are identified, controlled, and any changes are validated. Implement change control, event handling, and CAPA/action management processes in accordance with global Quality Management (QM) documents, monitor and trend accordingly. Maintain accurate records for equipment usage, calibration, maintenance, and repair including dates and responsible personnel. Oversee manufacturing equipment qualification, validation, and calibration programs. Ensure proper storage and handling of materials and products covering receipt, quarantine, sampling, storage, labeling, dispensing, processing, and packaging according to written procedures. Execute yield checks and quantity reconciliations to confirm no discrepancies exceed acceptable limits. Conduct in-process and environmental controls as required, ensuring accurate recording. Contribute to investigations of product quality defects. Control reprocessing or reworking of materials to prevent unauthorized use. Prevent cross-contamination and mix-ups during manufacturing, packaging, and labeling operations. Implement and monitor progress toward EHS policy objectives. Create, manage, and update documentation related to the Environmental Health & Management System. Maintain surveillance of compliance with legal and organizational requirements. Report EEHS performance metrics to top management. Conduct regular reviews of occupational risks and environmental aspects. Provide training and awareness to employees to minimize accidents and environmental impact. Liaise with corporate and global EEHS representatives regarding relevant issues. Conduct audits of the Environmental, Energy, and Health & Safety Management System Ensure realistic commitment to the production plan based on machine utilization and manpower availability. Collaborate with the Site Head to escalate and resolve key events affecting production, quality, and safety. Review and propose capital expenditure (CAPEX) and operational expenditure (OPEX) budgets. Lead and drive continuous improvement projects by identifying suitable opportunities and overseeing their implementation. Provide ongoing coaching and support to team members to build capability and strengthen performance. Proactively mitigate potential conflicts between internal and external stakeholders.
Posted 2 weeks ago
10.0 - 20.0 years
5 - 15 Lacs
Greater Noida
Work from Office
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 and Allergy Therapy Products, and Generics Solid Dosage Formulations. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma which is subsidiary to Jubilant Pharmova Limited. Jubilant Generics have 2 manufacturing sited at Roorkee, Uttarakhand and Salisbury, Maryland, USA engaged in manufacturing of Tablets and Capsules. 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 team focusses on B2B model for EU, Canada and emerging markets. Kindly refer www.jubilantpharmova.com for more information about organization
Posted 2 weeks ago
3.0 - 10.0 years
5 Lacs
Baddi
Work from Office
Responsible for Quality and quantity (% yield) of products packed and delivered. Responsible for cGMP compliance of the areas, preparation & updating of SOP. Responsible for Liquid orals packing, Steroid products packing, non-steroid products packing. Responsible for manufacturing of liquid, non-steroid and steroid products To ensure cGMP compliance in the manufacturing, primary & secondary packing area. Deliver the products as per the monthly plans given by HOD. To allocate the job to the workmen to achieve the best productivity. To ensure the up-keep of facilities and equipment s by making the notification to the concern departments for the preventive maintenance, calibration and requalification. To keep the packing area always ready for inspection through good documentation/ cGMP compliance of the plant and personnel hygiene. To motivate the workmen by proper training in activity and safety matter, timely guidance in shop floor monitoring so that they can achieve results successfully first time and for every time. To provide training to all employees. Set Production goals & objective for the production team with maximum output of best quality. Collaborate with QA/QC, warehouse and other departments for day to day activities Participate in Self inspection programs. Updating Production manager regarding Day to Day production activities. Investigate and answer market complaints, deviations and CAPA. Work distribution. Prepare & Review SOPs. Coordinate with Eng. Department for installation of new machines. Coordinate with R&D for new product manufacturing on site
Posted 2 weeks ago
12.0 - 15.0 years
10 - 12 Lacs
Baddi
Work from Office
Efficiently monitor all operations which affect the quality. Devise procedures for inspecting and reporting all the persisting quality issues. Assure the consistency and reliability of production with thorough checking procedures and final output. Supervise and guide inspectors, technicians, and all other staff. Report all malfunctions to production executives only to ensure immediate action. Appraise all the requirements of customers and ensuring they are quite satisfied. Facilitate proactive solutions by collecting and analyzing quality data. Keep permanent records of quality reports, statistical reviews, and relevant documentation. Review the current standards and policies. Communicate with external quality assurance officers during on-site inspections. Efficiently ensure that all the legal standards are met with great care. Provide assistance during the recruiting process. Efficiently create reports for tracking progress.Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications. Perks and benefits: Mention available facilities and benefits the company is offering with this job.
Posted 2 weeks ago
3.0 - 7.0 years
3 - 6 Lacs
Udaipur, Bangalore Rural
Work from Office
Participate in internal and external audits (USFDA, EDQM, WHO, MHRA, etc.),Ensure compliance with GMP, ICH, and regulatory guidelines in API manufacturing.Conduct in-process checks and ensure batch release activities are done per quality procedures. Required Candidate profile Experience of QMS software Exposure to regulatory audits and good Manufacturing practices. Strong communication and documentation skills. Sound knowledge of regulatory guidelines ICH, WHO, USFDA
Posted 3 weeks ago
5.0 - 8.0 years
6 - 10 Lacs
Navi Mumbai
Work from Office
Executive-CQA Long Description 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3.To execute vendor Audits, CAPA tracking, and qualification documentation 4.To schedule and monitor the Vendor Audits 5.To work on VQ special projects in coordination with Project IT team 6.To track the project till its implementation and Go Live across all sites Competencies 1. Strategic Agility 2. Innovation & Creativity 3. Customer Centricity 4. Developing Talent 5. Result Orientation Work Experience 5 - 8 years
Posted 3 weeks ago
5.0 - 8.0 years
7 - 11 Lacs
Navi Mumbai
Work from Office
Executive-CQA-VQG 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3.To execute vendor Audits, CAPA tracking, and qualification documentation 4.To schedule and monitor the Vendor Audits 5.To work on VQ special projects in coordination with Project IT team 6.To track the project till its implementation and Go Live across all sites Competencies 1. Strategic Agility 2. Innovation & Creativity 4. Developing Talent 3. Customer Centricity 5. Result Orientation Education Masters in Chemistry Post Graduation in Pharmacy 5-8 YearsWork Experience
Posted 3 weeks ago
12.0 - 15.0 years
11 - 16 Lacs
Navi Mumbai
Work from Office
Work Experience 12 to 15 years of experience in Pharma Vendor Audit Management 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3. To execute vendor Audits, CAPA tracking, and qualification documentation 4. To schedule and monitor the Vendor Audits 5. To work on VQ special projects in coordination with Project IT team 6. To track the project till its implementation and Go Live across all sites Technical , behavioral & managerial 1. Strategic Agility 2. Innovation & Creativity 4. Developing Talent 5. Result Orientation 3. Customer Centricity Education Masters in Pharmacy Post Graduation in Science or Chemistry
Posted 3 weeks ago
10.0 - 12.0 years
11 - 15 Lacs
Navi Mumbai
Work from Office
Job Description Responsible for Toxicological assessment of genotoxic and nitrosamine impurities. Responsible to support the development of nitrosamine and other genotoxic impurity risk assessment and carryover limits. To support the site management team in reviewing cleaning, nitrosamine and genotoxic impurity and keep sites up to date according to current regulatory requirement /expectation. Reviewing Permissible Daily Intake, Occupational Exposure Limits, Toxicological Justification, Quality Risk Assessment document. Responsible for preparation and revision of corporate procedures like SOP related to the assessment of potential carryover or cross-contamination of genotoxic/carcinogenic impurities. Harmonization of Cleaning and validation procedures across all sites of Lupin. Work Experience 10-12 years Education Masters in Science Competencies Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility
Posted 3 weeks ago
8.0 - 10.0 years
7 - 8 Lacs
Ranipet
Work from Office
Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Seminar / Presentation / trainings/ Management Review Meeting (MRM) etc. internally to achieve QMS Coordination for Technology Transfer Document (TTD) review and new product initiation. Reviewing and approving validation protocols and reports Approving intermediate and API contract manufacturers Ensuring that all Quality related complaints are responded as per SOP Review and Coordination for Batch Processing and packing record. Review of Quality Manual / VMP / SMF. Preparation and review of external audit responses then proposed CAPA monitoring. Maintaining Updated documents as per standard of ISO 9001:14001. Maintaining documents as per USFDA, CGMP, and other regulatory guidelines requirements. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline Any other activities assigned by reporting manager.
Posted 4 weeks ago
8.0 - 10.0 years
7 - 8 Lacs
Ranipet
Work from Office
Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Seminar / Presentation / trainings/ Management Review Meeting (MRM) etc. internally to achieve QMS Coordination for Technology Transfer Document (TTD) review and new product initiation. Reviewing and approving validation protocols and reports Approving intermediate and API contract manufacturers Ensuring that all Quality related complaints are responded as per SOP Review and Coordination for Batch Processing and packing record. Review of Quality Manual / VMP / SMF. Preparation and review of external audit responses then proposed CAPA monitoring. Maintaining Updated documents as per standard of ISO 9001:14001. Maintaining documents as per USFDA, CGMP, and other regulatory guidelines requirements. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline Any other activities assigned by reporting manager.
Posted 4 weeks ago
3.0 - 8.0 years
4 - 7 Lacs
Nagpur
Work from Office
Qualification : B.Pharma Experience : 3 to 10 yrs. Designation : Officer Salary Range : 6 to 7 Lacs PA. Unit : Injectable Kindly Find the JD. Management of Aseptic Process Simulation (Media Fill) Program. Review of quality systems such as Change Control, Deviations, CAPA, OOS, OOT, LIR, Market Complaint, FAR, Product Recall and other QAMS documents. Preparation and Review of APQR. Nitrosamine Risk Assessment of Drug Product Preparation and review of site QA SOP and review of cross-functional department SOP. Review of Batch Manufacturing Record and Batch Packing Record. Preparation, review and execution of hold time study of drug product. Preparation and review of thermal cycling and temperature excursion study If interested mail cv at :- neetij@selectsourceintl.com
Posted 4 weeks ago
10.0 - 18.0 years
12 - 22 Lacs
Navi Mumbai, India
Work from Office
Job Responsibilities: 1. Monitoring and Assessment of QMS related activities for all API sites (Nerul, Chiplun and Ambernath) and Govandi (CPRL, PAN, BRL etc.). 2. Change Controls: Review and closure of change controls, approval and closure of actions childs, CQA Assessment etc., 3. Review of Customer Complaints, Risk Assessments, Deviations, CAPAs, Investigations, Recalls etc., 4. Handling of Customer Quality agreement and co-ordination with cross functional team till execution of the agreement. 5. Tracking of CQA SOPs as per the review date, by maintaining the SOP Periodic review tracker and master SOP list. 6. Preparation/Revision of CQA SOPs and making master, effective after completion of training. 7. Review of Master formula and technology transfer documents for API sites. 8. Master product label information update in Traces application as per the site requirement. 9. To provide training of SOPs, cGMP, or other modules as per the requirement. 10. Review of SOPs related to various departments of corporate functions (e.g. CPRL, PAN Lab, HR etc). 11. Scheduling and participation in self-audits (Sites and corporate functions). 12. Regulatory and customer audit support to sites. 13. Review of Specifications for raw material, intermediate, finished API, working standard, GTPs of API Sites in DocuSign. Master and making effective through DocuSign and distribution of controlled copies to site and CFTs. 14. Handling Customer Questionnaires, Regulatory Agencies Questionnaires and Customer queries as per the requirement. 15. Participation in Quality related meetings. 16. Shall perform any other related work/projects assigned by CQA HOD/Section head.
Posted 4 weeks ago
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