113 Cgmp Jobs

Experience in pharma regulatory & QMS function, primarily in RLD / comparator sourcing, clinical trial supply chain management, and clinical packaging for USA and EU markets. The role includes supporting the end QMS function and regulatory affairs. Health insurance Provident fund Annual bonus

Role & responsibilities JD- Designation: Deputy manager Department: QA Role: vendor qualification Experience:6-10 years of relevant experience. 1)Preparation and Review of procedures related to Vendor management as per regulatory requirements. 2. Review of QMS elements like Change management (Change control), Deviation, CAPA, related to external testing laboratories, service providers. 4. Management of vendor qualification (Related to Contract services/ contract Labs /CMO) documentation i.e. initiation of vendor assessment, tracking of their audit and periodic monitoring. 5. Responsible for vendor Audit Schedule, Execution of site audit for Contract Testing Laboratories, Contract Service Providers. 6. Preparation of Vendor audit reports, reviewing Audit CAPA reports, regular Follow-up to vendor for closure of Audit Observations. 7. Updating of Approved vendor list. 8. Handling of Quality Agreements/CDA with Vendors (Contract Testing Laboratories, Contract Service Providers) 10. Preparation of annual periodic verification of Vendors. Preferred candidate profile

Implement Amgen Quality Management System Identify Continuous Improvement opportunity for Quality Management System Develop Quality Procedures align with Amgen Quality Management System, cGMP requirements, GDP requirements and local regulations Oversight operations of local distributors and stockist to ensure local distributors operations are in compliance with cGMP requirements, GDP requirements, Amgen Quality Management System and Local regulations Act as Quality-related interface with internal and external customers (i.e. : Change control, Non Conformance, Product Complaint, Product Recall, Audit/ Inspection) Support local testing Support BD project and product launches Liaise with internal and external partners to manage day to day operations associated with distribution operations Monitor and ensure on time completion of NC, CAPA, Audit observation, Product complaint and other quality events Develop and Maintain the Quality Agreements with local distributors and partners Develop reports and provide the necessary communications throughout the organizations Develop or review or approve GMP and GDP documents Provide training to distributors and stockiest including distributors/stockist on-boarding training Actively participate on GMP intelligence to review local regulations, standards and guidance related to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), product testing and Pharmacopoeia requirementsin India. Collaborate with Risk Management and Product Security on handling of counterfeit, product tempering, product theft and product diversion Interact with local regulators as needed. Keep the Senior Manager International Quality - JAPAC informed of the progress of projects and goals and advise on the potential areas of risk/ concern and new developments that may impact the company Support Named Patient Program Supplier Management:Performqualityoversight and audit of key suppliers to Amgen and its subsidiary companies. These suppliers can include API and starting material manufacturers as well as raw materials, devices and finished products suppliers, contract facilities, local laboratories, importers, distributors, logistics service providers, warehouse, etc. Apply advanced knowledge of Indian and global market regulations to assess supply security risks. Work on an active risk management tool etc. to appropriately deploy Quality Systems on oversight of Amgen suppliers; including selection and approval, due diligence assessment, intelligence monitoring, on-site visit/audit and (if needed) Person in Plant placement, etc.. Support in identifying, assessing and addressing supplier s GMP/GDP risks in collaboration with Amgen sites. Execute necessary tasks and projects as assigned by management in timely manner; to attain assigned goals. Provide support for regulatory inspections of key facilities as needed. Qualifications Pharmacist Registration in India. Hold a valid practicing certificate as Pharmacist in India. In-depth knowledge and experience of Good Manufacturing Practice (GMP) & Good Distribution Practice (GDP). Experience with Quality Management Systems including but not limited to change control, deviation, validation, complaints, disposition and audits/inspections. Experience with Commercial Quality Operations and third-party management. Experience with distribution models and/or establishment of new entity procedures a plus

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.

To handle DCS as operator. Ensure batch charging & other manufacturing operations should be strictly as per BMR/SOP & in line with current GMP practices. To maintain manufacturing records online & should comply data integrity practices. To take out sample of intermediate/in-process material and send to IPQC/QC lab. To ensure the production related inputs in SAP system. To be check and ensure the PISCADA reports generation & review of DCS alarms. Transfer finished goods through Finished Goods Transfer Note. To Check and ensure minimum stock of consumables, Logbooks & status labels. Ensuring preventive maintenance of all equipment as per schedule. Co-ordinate with service departments (QA, QC, stores, E & M) for various production related activities. If any abnormality found in production area / activities, authorized to stop activity immediately & inform to superiors/production Manager. Responsible to maintain housekeeping in plant & take care the cleanliness of equipment. Follow safety instructions/procedures & ensure use of safety outfit while on works. To attend GMP & safety trainings & implement the trainings outcome at work place. Should be aware of the location of firefighting equipment and should know the operation. He should not leave the work spot unattended and go away without prior permission from shift-in-charge/Manager Responsible for allotment of work to operators & casuals. To involve in other initiatives such as AET & CSR

Lead research and development of APIs, excipients, and formulations. Optimize existing formulations and explore new product ideas. Conduct laboratory research, testing, and documentation. Collaborate with QC, production, and regulatory teams. Required Candidate profile Min 10 years of R&D experience in the pharmaceutical sector. Strong knowledge of formulation science, GMP, and regulatory norms. Skilled in analytical techniques, lab procedures, and instrumentation.

Roles and Responsibilities Prepare and review batch manufacturing records (BMR) and batch processing documents to ensure compliance with regulatory requirements. Monitor production processes to identify areas for improvement and implement changes to optimize efficiency and productivity. Collaborate with cross-functional teams to resolve issues related to product quality, process optimization, and equipment maintenance. Ensure adherence to cGMP guidelines throughout the production cycle.

Responsible to monitor operations in granulation, blending area, compression, coating and tablet inspection area. Responsible to manufacture and ensure quality of the product at respective processing area. Responsible to follow all regulatory/cGMP/Statutory/Company policies are followed in manufacturing area. Responsible for online documentation with real time data. Responsible to participate in equipment qualification and process validation activities Preferred skills : Granulation, Compression, coating and packing of & Exposure in OSDs

Mode of Work : Hybrid Location : Pune, Bangalore, Hyderabad, Pune, Noida, Gurgaon, Chennai, Kolkata, Skill Set : LIMS, GMP, cGMP, Starlims, Labware Lims, Labvantage. The opportunity Were looking for Senior with expertise in LIMS Implementations & Configurations for Life Sciences industries to join our Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your key responsibilities Work closely with business stakeholders, laboratory personnel, and IT teams to gather and document LIMS requirements. Gather and analyse business requirements related to LIMS functionality and enhancements. Analyse laboratory workflows and processes to recommend and implement LIMS solutions. Translate business needs into functional specifications and system configurations. Configure, test, and validate LIMS functionalities to meet business needs. Conduct impact analysis and risk assessments for LIMS changes and enhancements. Serve as a liaison between business users and technical teams to ensure effective communication and system alignment. Participate in business process mapping and workflow optimization to enhance LIMS utilization. Provide input on LIMS enhancements and new feature development to improve system performance. Assist in troubleshooting, identifying, and resolving LIMS-related issues. Conduct user training sessions and provide end-user support. Work with laboratory teams to ensure LIMS supports laboratory practices, procedures, and workflows effectively. Identify opportunities for automation and process improvement within laboratory operations using LIMS. Master Data Design Configuration Analyse the Technical documents such as SOP/STP/Monograms/Pharmacopeial references and convert them into LIMS compatible data sets. Configure master data elements such as test methods, sample types, specifications, workflows, and stability studies within LIMS. Maintain data integrity, consistency, and version control across the system. Implement changes and updates to LIMS master data in alignment with business and regulatory needs. Collaborate with cross-functional teams to ensure accurate data migration and system integration. Troubleshoot and resolve issues related to master data configuration and system functionality. Work on optimizing data structures and database management within LIMS. Configurations & Customizations Develop, customize, and implement LIMS applications to meet laboratory and business requirements. Configure, extend, and support LabWare LIMS, LabVantage LIMS, and other LIMS platforms. Integrate LIMS with other enterprise systems such as ERP, ELN, CDS, MES, and laboratory instrumentation software. Design and optimize databases for efficient storage and retrieval of laboratory data. Develop and maintain system interfaces, workflows, and automation scripts to streamline laboratory processes. Provide technical support, troubleshooting, and bug fixes for LIMS applications, ensuring minimal downtime. Collaborate with laboratory personnel, IT teams, and stakeholders to enhance system functionality and usability. Create and maintain system documentation, including user guides, SOPs, validation protocols, and technical specifications. Ensure compliance with industry standards such as CGxP, PICS, FDA 21 CFR Part 11, EU GMP Annex 11 etc. Stay up to date with new LIMS technologies, trends, and best practices. Ensure system security, access control, and compliance with IT policies. Provide ongoing support and maintenance for LIMS applications. Engage in change management processes and drive adoption of new system functionalities. Work with vendors and third-party providers to Configure, implement upgrades and enhancements. Demonstrate teamwork by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills and attributes for success Strong understanding of laboratory workflows, sample lifecycle management, and data integrity principles. Familiarity with analytical techniques, laboratory instrumentation, and regulatory standards. Exposure to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and ISO 17025 compliance. Experience in working with scientific and analytical teams to align LIMS functionality with laboratory operations. Understanding of quality control, stability studies, environmental monitoring, and batch release processes within laboratories. Proficiency in LIMS software (e.g., LabWare, LabVantage, STARLIMS, SampleManager, or similar platforms). Knowledge of system integration with ERP, MES, or other enterprise applications. Previous experience as a Business Analyst or System Administrator or Master Data Manager working with LIMS. Hands-on experience in master data configuration within LIMS platforms. Experience in system validation, testing, and documentation. Exposure to Enterprise IT applications like ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, etc. in Pharmaceutical organization Understanding of relational databases and SQL queries. Experience with scripting or automation tools for LIMS is a plus. Understanding of API integrations, web services, and middleware solutions for LIMS. Ability to troubleshoot system and data issues efficiently. Strong problem-solving and analytical skills. Excellent communication and stakeholder management abilities. Ability to work independently and as part of a cross-functional team. Strong attention to detail and commitment to data integrity. Adaptability to dynamic business and regulatory environments. Demonstrated track record in project management, governance, and reporting Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management. Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Comp. Science/ Life Sciences/Chemistry/Information Technology or a related field)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 4-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies or Leading Life sciences / Pharmaceutical Industries. Good interpersonal skills; Good written, oral and presentation skills. Interested Candidates can send their Cv's to frichardson@allegisglobalsolutions.com. Regards, Franklin.A

Job Objective: Plan, allocate and review testing for the release of all RM, processed material, finished products to achieve the committed lead time for Production and for achieving targeted OTDIF Maintain microbiological laboratory GLP compliant as per Schedule L of Drug and cosmetic act. Ensure implementation and sustain of safe environment in microbiology laboratory. SOP review & availability of current version Roles and Responsibilities: Daily review of testing of FP, RM, Water, Air, In-process & Swab as per given procedure and frequency. Daily work allocation to microbiologists. Daily review of records and logbooks maintained in microbiology laboratory. Daily communication to operation and QA for any OOS or OOT related to microbiology testing. Investigation and root cause analysis in case of microbiological failure (OOS/OOT) and implementation and sustenance of CAPA CAPA checklist audit as per define checklist and presenting data to higher management during global micro meeting. Review of microbiological trends for air and water as per define procedure and frequency. Surveillance of shop floor for GMP adherence. SAP entry for finished product in absence of microbiologists Maintaining microbiological laboratory as per laid down procedure. Review of Q & V documents related to microbiological risk involved. Review of validation activities in microbiology laboratory. Composite sample preparation and insurance in absence of microbiologist. Microbiology awareness training to shop floor people. Laundry audit / Monitoring of Housekeeping activities & Self inspection of various departments GLP and documentation, laboratory facility maintenance Microbiological testing of FP, RM, Water & Air in absence of other microbiologists

We are seeking an experienced and dedicated EHS Manager to lead our Environmental, Health, and Safety (EHS) initiatives at our Bangalore plant. This position is a people manager role, responsible for ensuring compliance with CGMP standards and the safe handling of chemical products. The EHS Manager will play a crucial role in fostering a culture of safety and sustainability within the organization. Leadership and Management: Lead and manage the EHS team, providing guidance, support, and development opportunities. Foster a culture of safety and environmental awareness among all employees. Compliance and Standards: Ensure Statutory compliance with local/national body , like Factory & Boiler departments, PCB, CPCB, Labor compliances , Environmental clearances and international EHS regulations and GMP standards, Proper Knowledge of Process safety. Develop, implement, and maintain EHS policies and procedures in alignment with corporate standards. Risk Assessment and Mitigation: Conduct regular risk assessments and audits to identify potential hazards and implement corrective actions. Monitor and analyze EHS performance metrics, reporting findings to senior management. Training and Development: Develop and deliver EHS training programs for employees at all levels. Promote continuous improvement in EHS practices through education and awareness initiatives. Incident Management: Lead investigations of EHS incidents, ensuring thorough analysis and implementation of preventive measures. Maintain records of incidents and ensure timely reporting to regulatory authorities. Sustainability Initiatives: Drive sustainability initiatives aimed at reducing waste and promoting resource conservation. Collaborate with cross-functional teams to integrate EHS considerations into operational practices. Who You Are: Bachelors degree in Environmental Science, Occupational Health and Safety, Chemical Engineering, or related field. Minimum of 10 years of experience in EHS management preferably in chemical Manufacturing Environment, certificate/Diploma in EHS recognized by state Government /Central Government. Strong knowledge of CGMP standards and chemical safety regulations, Hands on Experience in HAZOP study & Knowledge of PCB regulation i.e ETP/STP etc . Proven leadership skills with experience in managing teams. Excellent communication and interpersonal skills. Ability to analyze complex EHS data and develop actionable strategies.

Sodexo Food Solutions India Pvt. Ltd.ces is looking for MIS Admin Assistant to join our dynamic team and embark on a rewarding career journey Oversee the design, implementation, and maintenance of the information systems, including hardware, software, and networking infrastructure Manage the database systems, including data backup and recovery, data security, and data integrity Develop and maintain procedures for managing the information systems and technology infrastructure, including disaster recovery plans, security policies, and user access controls Analyze the business processes and identify opportunities for improvement through the use of information systems and technology Collaborate with cross-functional teams, including IT, finance, and business operations, to integrate information systems and technology with other systems and processes Monitor system performance and provide technical support to end-users to ensure the smooth operation of information systems and technology Strong analytical and problem-solving skills Excellent communication and collaboration skills

Hi, Greetings from Avani Consulting!!! Walk in Invitation: We have job opportunity with API Manufacturing Plant for Associate /Sr. Associate Production Profile for Mysuru Loaction. Interview Location BANGALORE We are having face to face interview on 21st June Saturday in Bangalore.- Single Round Face to face Company : A leading Pharma API Unit - in Mysore Position - Production Department Associate /Sr. Associate Work Experience Min 5 yrs in API in current Salary 20% to 25 % hike on current CTC. Note: No Charges If interested drop your CV to Shweta Gupta [ 7015954549|| shweta@avaniconsulting.com ] Thanks & Regards Shweta Gupta

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

To ensure that all raw materials (API & excipients) are sampled, tested, and released. Key Responsibilities: 1. Sampling & Receipt 2. Testing & Analysis 3. Documentation & Release 4. Compliance & Audit Readiness 5. Instrument Handling Required Candidate profile Candidate must have experience in handling team of minimum 10 members. Candidate must have experience into routine analysis of raw material and QMS knowledge.

1. Should be handle instrument activity of project 2. Should know the cGMP awareness related to project 3. Document Handling (DQ,IQ,PQ) Kindly share your updated CV on sneha.shinde@embio.co.in & kchoudhary@embio.co.in

Harman Finochem is looking for a skilled Technology Transfer Executive to join our team. In this role, you'll be crucial in facilitating seamless technology transfers, ensuring robust documentation, and maintaining compliance with key regulatory guidelines. If you have hands-on experience with process validation, cGMP, and possess strong analytical and communication skills, we encourage you to apply! Key Responsibilities Documentation & Compliance: Prepare and manage essential documents such as BMR (Batch Manufacturing Record), Process Validation Reports, Stability Protocols, and Sampling Plans . Initiate and ensure the proper closure of Change Controls and Deviations in accordance with GMP (Good Manufacturing Practices) . Apply good knowledge of GDP (Good Documentation Practices) . Maintain good knowledge of regulatory guidelines including SUPAC (Scale-Up and Post Approval Changes), cGMP, Compliance, ICH Q1A, Q2, Q7, Q8, Q9, A10, and Q13 . Gap Assessment: Conduct GAP assessments between sending and receiving unit equipment, instruments, and documents to identify and address discrepancies. Scale-Up/Down & Experimentation: Utilize sound Scale-up/down knowledge , including calculations, forecasting, and risk assessment. Plan and perform Lab-scale experiments . Communication & Coordination: Ensure effective communication and coordination with Cross-Functional Teams (CFTs). Software Proficiency: Demonstrate hands-on experience with Advanced Microsoft Word, PowerPoint, and Excel . Preferred Candidate Profile Experience: Must have experience in Tech Transfer Department Documentation . Education: M. Pharma in Pharmaceutics. Software Proficiency: Proficiency in MS-Word, Excel, and PowerPoint. Perks and Benefits As per Company Standards.

Head of Engineering & Maintenance- will lead all engineering and maintenance operations for a large-scale API pharmaceutical plant. This role is responsible for ensuring the optimal performance, reliability, and compliance of plant equipment, systems, and facilities. The position requires extensive experience in API manufacturing, including expertise in CGMP, FDA regulations, and managing regulatory audits. Develop and execute maintenance strategies, drive continuous improvement, manage OPEX budgets, and lead a high-performing team to ensure safe, efficient, and compliant plant operations. LOCATION: Digwal, Hyderabad REPORTING STRUCTURE: Reports to Global Engineering & Project head & Site head , Direct reportees all plant engineering & maintenance team ESSENTIAL QUALIFICATION: Bachelors degree in Engineering (Mechanical, Electrical, or related field) RELEVANT EXPERIENCE: > 20 years in a Pharmaceutical API Facility Leadership & Strategy: Lead, manage, and develop the Engineering & Maintenance team to drive plant operational excellence. Develop and execute a comprehensive maintenance strategy, ensuring a proactive approach to maintenance, asset integrity, and equipment reliability. Drive continuous improvement initiatives to optimize plant performance and reduce unplanned downtime. Manage operating expenditure (OPEX) budgets for Engineering & Maintenance activities. Maintenance & Reliability Management : Ensure all critical equipment and systems are maintained in optimal condition to meet production goals and regulatory requirements. Oversee the implementation of preventive and predictive maintenance programs, improving plant uptime and reliability. Develop and implement a comprehensive asset management strategy, including lifecycle management for critical equipment. Regulatory Compliance & Safety : Ensure all maintenance activities are compliant with GMP, FDA, and other relevant pharmaceutical regulations. Promote a culture of safety and adherence to the highest environmental, health, and safety (EHS) standards. Lead the investigation and resolution of any maintenance-related incidents, ensuring timely and effective corrective actions. Team Development & Talent Management : Mentor, train, and develop Engineering & Maintenance personnel, ensuring their skills and capabilities meet the evolving needs of the plant. Foster a culture of collaboration, teamwork, and continuous learning within the team. Lead recruitment efforts to fill skill gaps within the department and drive talent development initiatives. Collaboration & Cross-Functional Coordination : Work closely with Production, Quality, and Supply Chain departments to ensure alignment between maintenance schedules and production plans. Collaborate with the plant leadership team to identify opportunities for process optimization, cost reductions, and productivity improvements. Technology & Innovation : Identify and implement new technologies that improve equipment performance, reduce maintenance costs, and enhance production efficiency. Stay current with industry best practices, technology advancements, and emerging trends in pharmaceutical manufacturing and maintenance Key Competencies: Must have extensive experience in API pharmaceutical manufacturing, with a deep understanding of CGMP, FDA regulations, and other regulatory audit requirements. Expertise in ensuring compliance with these standards while optimizing maintenance strategies and driving operational improvements is essential. The role requires a strong track record in managing audits, addressing non-conformities, and maintaining a high standard of product quality and safety.

Job Description Candidate should the exposure for handling the Bottle packing line. Should have the work experience in Regulatory plant. Faced the USFDA, MHRA,TGA inspection. Good Communication skill. Having the SAP knowledge. Work Experience 3 to 05 years' Experience. Education Graduation in Pharmacy Competencies

1. Quality Management Systems: Implementing, monitoring, and maintaining Quality Management Systems to ensure compliance with CGMP/regulatory guidelines. 2. Documentation: Reviewing and approving technical and quality documents. Required Candidate profile Should be minimum Post Graduation in Science having the work experience of about 6-7 years of experienced in FMCG company or in pharma industry.

Developing and Implementing QA Systems and Procedures: Responsible for establishing and maintaining quality assurance systems, policies, and procedures. This includes creating SOPs (Standard Operating Procedures), work instructions. Required Candidate profile Strong knowledge of cGMP and relevant regulatory requirements: This includes understanding manufacturing processes, quality control procedures, and validation requirements.

Responsible for maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485:2016 and Local regulatory requirements (Indian Medical Device Rule). Responsible for internal audits, CAPA, change control, document control, risk management, and management review processes. Support external audits/inspections (Notified Body, regulatory, customer). Ensure compliance with applicable regulatory requirements and support quality system documentation updates. Collaborate with cross-functional teams to ensure quality and compliance across product lifecycle stages.

Role & responsibilities Trainee Production Chemist Preferred candidate profile B.Sc or M.sc 2024-25 passout candidates willing to work in Production Departmant only can apply .

Raise laboratory Change control, incidents, deviations and LI wherever applicable. Review of Instrument qualification and scheduled calibration planner. Ensure proper laboratory analysis as per MOA and current product specification.

Handle BMR and batch repacking records, Verify daily balance checks and calibration activities, Maintain production records, Perform and verify line clearance at manufacturing and packing stages, Issue and retrieve production documents Required Candidate profile Graduate candidates with 2-5 Year experience and knowledge about cGMP Practice, QMS tools knowledge, Production and Manufacturing documentation process. We are looking for local candidates ONLY.