Key Responsibilities: Execute routine downstream operations including chromatography (affinity, ion exchange, HIC), filtration techniques (TFF, UF, DF, NF), buffer preparation, and formulation of mammalian cell culture-derived products. Maintain accurate documentation including batch records, deviation reports, SOPs & other QMS elements. Support scale-up and tech transfer from lab to pilot/production scale. Ensure strict compliance with cGMP and safety protocols. Collaborate with QA/QC, maintenance, and engineering teams for smooth operations. Troubleshoot process deviations and contribute to root cause analysis and CAPA implementation.

Role & responsibilities Sr.Executive : QMS & engineering documentation Primary Responsibilities: 1. Responsible for GMP compliance, as per procedures define and implementations of GxP practices. 2. To ensure the GDP and data integrity in routine/daily activities/operations. 3. Responsible for QMS documents related to engineering. 4. Audits & compliance 5. Preparation of SOPs, review & periodic revisions 6. To attend /or supervise all jobs related to Electrical/ Instrumentation Engineering activities at site. 7. Timely execution of equipments/instruments as per schedule coordination with user. 8. To attend emergency breakdowns of all plant wide machines round the clock as and when required. 9. Maintain the Spare parts of all critical Instruments in site. 10. Timely execution and completion of Validation/ Qualification activities at site. 11. Execution of all In-house Projects in Electrical/ instrumentation in site. 12. Maintain the calibration logs, area /equipment logbooks, preventive maintenance schedule of all the activities. Preferred candidate profile

Role & responsibilities Job Responsibilities/Descriptions 1.0 Working / Real time experience on Digital platforms like DMS, TMS, ERP, LIMS, QMS and different application software used in production and QC. 2.0 Knowledge on 21 CFR PART 11, GAMP guidelines. 3.0 Provide expertise and guidance to the project/cross function team on computerized system validation activities to meet GxP regulatory needs with focus on Data Integrity. 4.0 To ensure computerized systems validation, and compliance throughout the life cycle of the Equipment/system to comply with the site procedures and Regulatory requirements. 5.0 Preparation of Computerized Systems Validation Master Plan and Gap assessment (if required) as and when needed. 6.0 To Identify and mitigate risks related to computerized systems at the site level. Prepare/support risk assessment documents and ensure execution of validation activities based on assessed risk. 7.0 Knowledge on computerized system inventory and GxP risk classification/ Impact Assessment. 8.0 Review and preparation of URS, FS, IQ, and OQ documents related to GxP computerized system, IS infrastructure and participate in qualification/validation or compliance verification of computerized systems. 9.0 Knowledge on Audit trail review. 10.0 Prepare/ review the computerized systems SOPs and ensure the site, GxP regulatory requirements. Preferred candidate profile

Role & responsibilities Job Responsibilities/Descriptions 1.0 Knowledge on Guidelines (ISPE, PDA, ICH) regulation (FDA & EMA). 2.0 Participate in Equipment, Area, Utilities and Facility qualifications. 3.0 Preparation and Review of URS, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Commissioning Studies, and SOPs related to Equipment/systems. 4.0 To monitor the Performance Qualification of various equipment and systems at site. 5.0 Review of Performance Verification protocols and reports. 6.0 To be part of process validations studies like Washing Validations, Mixing Validations, CIP and SIP validations, Filling Validations, Capping Validations, Autoclave, DHS Validations and providing support for preparation and review of summary report. 7.0 Review and verification of Calibration, Preventive Maintenance and Annual Maintenance records of equipments related to GMP Area. 8.0 Handling of Qualification related change controls, Deviation and CAPA initiation and closure. 9.0 Handling and knowledge on breakdowns, Notifications, and clearance request. 10.0 Basic knowledge on 21 CFT part 11 requirements. 11.0 Prepare/support risk assessment documents and ensure execution of validation activities based on assessed risk. Identify and mitigate risks related to computerized systems at the site level. 12.0 Preparation and review of the SOPs related Qualification, validation (Including CSV) and review of Engineering SOP. 13.0 To ensure the Audit trails and data integrity compliance for GxP computerized systems. 14.0 Reviewing and approving (or rejecting) validation or qualification protocols and or reports. 15.0 Providing Quality oversight on engineering activities. Knowledge on Preventive maintenance and Calibration. Preferred candidate profile

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

Role & responsibilities Job Responsibilities/Descriptions Primary Responsibilities: 1. To ensure shop floor compliance of Visual Inspection, Packaging, warehouse and Dispatch operations as per cGMP and cGWP requirements (IPQA activities). To prepare and review SOPs, study protocols, SPRs, TPRs pertaining to Fill finish, warehouse and quality assurance as required. 3. To Support in visual inspection qualification kits and visual inspection operator qualifications. 4. To review the trends of visual inspection results. 5. To support the Validation Team during the qualification activities at the area. 6. To provide Line Clearance for Visual Inspection, Packaging, Dispensing and Dispatch operations, verification of In-Process checks as defined in the batch records / SOPs. 7. To perform AQL Visual Inspection of filled units as per SOP / instructions. 8. To perform Pre-Dispatch Inspection (PDI checks). 9. To verify and ensure routine compliance of Visual Inspection and Packaging activities as per the batch records/SOPs and verification of the online documentation against each process stage, including logbooks 10. To Suppott Artwork development and management. 11. To Support in Transport Validation of Finished Products. 12. To Support and facilitate timely closure of Change Controls, Events / Deviations, CAPA pertaining to Visual Inspection and Packaging areas, support investigations. 13. To co-ordinate with all cross functional departments for operations related to Quality Assurance. 14. To ensure the readiness of shop floor for audits by Regulatory Authorities / customers. 15. To support market compliant investigations. 16. Ensure to perform daily random checks on material reconciliation at warehouse and report the discrepancy. 17. Ensure the warehouse documents verification and its compliance. 18. To Support and facilitate timely closure of Change Controls, Events / Deviations, CAPA pertaining to warehouse and Dispatch areas; support investigations. Secondary Responsibilities: 19. Follow the safety precautions at packing and warehouse areas. 20. Support the internal audits. 21. Any other responsibilities assigned by supervisor / head of the department.