Biocon Pharma Ltd
Designation : Senior Manager
Function : Quality Assurance
Functional Area : QA GENERIC FORMULATIONS
Job Role Summary : Team Lead – IPQA (OSD), Line clearance, document review, Batch release, APQR, Change controls review, Â
Job Profile :
- IPQA Lead Ensuring all activities comply with established quality standards, including line clearance, In process sampling, and batch document review.
- Plan and execute in-process manufacturing assurance and batch release functions Managed investigations across the site including conducting, reviewing, and approving investigations.
- Scheduling, review and approval of annual product quality reviews (APQR)
- Responsible for the review and approval of change controls, CAPA & Market complaints.
- Preparation Review and approval for Standard Operating Execution and Review of Risk Assessment Preparation.
- Review and approval of Process validation protocols & reports SAP Knowledge on Batch release & Material
- Movement Regulatory Audits Handling Internal Audits Handling.Â
- IPQA activities Monitoring Batch Release /Rejection Change control / CAPA/Deviation/Market complaint review and approval Scheduling & Ensuring APQR preparation.
- Preparation Review and approval for Standard Operating procedures Regulatory Audits Handling Performing Internal Audits.
- Training to the peer group Decision Making Skills Excellence in Analysis and Problem Solving.
Job Requirements :
- 15-17 years in formulations QA
- Familiar with IPQA - OSD, Batch review and compliance, Batch release, Handling QMS documents, investigations
- Exposure to regulatory audits
Work / Job Experience : 15-17 Years
Type of Experience : Pharma QA, IPQA, Line clearance, QMS, Batch review and release
Academic Qualifications :
B Pharma / M Pharma
