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.
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.

Qualification: B Pharma / M Pharma

Experience: 15 to 17 years

Team Lead - IPQA (OSD)