Job Title: Assistant Manager - QA
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
M.Sc. Micro/M.Sc.Biotech/B.Pharma/M.Pharma
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
Biotech, Ahmedabad, GJ, IN, 382213