IPQA Lead – OSD Manufacturing | Zydus Pharmaceuticals | Ahmedabad

Job Description

Zydus Pharmaceuticals is looking for an IPQA Lead for its OSD Manufacturing Facility based out of Ahmedabad.

Role & Responsibilities:

• Working as IPQA lead and leading team of QA professionals having exposure to Line clearance, In Process, Sampling of In process and finished products, Swab sampling and Review of BMR for manufacturing and Packing line in Oral Solid Dosage Manufacturing facilities.
• Directing the In-process controls during product manufacturing and packaging Authorizing various documentation including batch documents, Validation & Qualification documents, Hold time, scale up and Technology transfer documentation.
• Reviewing the systems, cGMP compliance and their improvement Preparing & reporting the monthly quality report.
• Extensive experience in In-process Quality Assurance as a team Leader of IPQA Team for implementation of compliance in Manufacturing area as per cGMP.
• To review all GMP-related documents (SOP, PROTOCAL, and Reports ).
• Reviewing BMR, BPR, and compilation of documents for batch release.
• Handling of Audit Trail review and periodic audit trail review.
• In-process monitoring of manufacturing activities of Tablets and capsules.
• Document review of quality and manufacturing as APQR, SOP, Validation Protocol, Hold time Protocol and reports, manufacturing investigation report, and all other GMP-related documents.
• Handling of internal audit.
• Investigation to find out the root cause for any nonconformance.
• Verify the process validation sample as per the process validation protocol.
• Handling all areas as per regulatory compliance.
• .

Desired Candidate Profile:

• The candidate should be from the Pharma(OSD) Industry only.
• The candidate should Have knowledge and Exposure of GDP/ GMP.
• The candidate should have good communication skills (Verbal and written)
• The candidate should have Regulatory exposure(USFDA).
• The candidate should be Handling the team of IPQA professionals in his current role.

Qualification: B.Pharma, M.Pharma

Experience: 18- 22 Years of Relevant Experience

Salary: 18.00 – 22.50 L CTC/PA

Key Skills: OSD, IPQA, IPQA Lead Role, IPQA Head, QMS, In-process Quality