Job Title: Manager - QA
Competencies
Purpose of Job
Responsible for managing and coordinating Quality Assurance functions with respect QMS, Product Life cycle, Investigations, IPQA and Annual Product Review for Drug substance.
Skill Required
Roles and Responsibilites
- Handling of investigations for Deviation, OOS/OOT, Product Quality Review, CPV (Continued Process verification) and Incident. Review, assessment of and coordination for investigations including cross functional discussions.
- Dealing with day to day IPQA activities like shop floor compliance, GMP operation monitoring, SOP and BPCR walk down, gap findings in manufacturing documents and fixing them, audit trail review, document review etc.
- Drive and support the Market Complaint/Return/Recall system at Intas-Biopharma site. Ensure the complaints are logged, investigated in stipulated timeline. Investigations are shared to business partner/customer/complainant on time as well as follow up for feedback.
- Perform Mock recall as per SOP with appropriate conditions and case study. Coordinate with Business partner/Customer and external stakeholders in Mock recall process.
- Handling of Product Quality Review for Drug Substance. Coordinate with stakeholders for timely data compilation, trending, assessment and APQA preparation.
- Participate in Process Performance qualification (PPQ), review documents generated during the PPQ.
- Handling of Continuous CPV program for implementation and monitoring. Review and approval of CPV protocols and reports.
- Participate in Cleaning validation and verification program, ensure compliance and guidance is followed during validation/verification. Review and approval of validation/verification protocol and report.
- Review and approve the study protocols, evaluation reports, risk assessment, and other miscellaneous reports generated by MSAT.
Qualification Required
M.Pharm/M.Sc
Relevant skills / Industry experience
Having sound knowledge in Biosimilars industry.
Relevant professional / Educational background
Any other requirements (If any)
Compensation / Reward
Biotech, Ahmedabad, GJ, IN, 382213