Greetings from Zydus Pharmaceuticals!!!!
We are looking for IPQA Lead for our OSD Manufacturing Facility based out of Ahmedabad.
- Education Qualification: M.Pharmacy/ B. Pharmacy
- Experience : 18-20 Years of experience in IPQA .
- Salary: 18-22.5 Lacs P.A.
Roles and 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 of 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 Tablet, Capsule.
Document review of quality and manufacturing as APQR,SOP, Validation Protocol, Hold time Protocol and reports, manufacturing investigation report, and all other GMP related document.
Handling of internal audit .
Investigation to find out the root cause for any non conformance.
Verify the process validation sample as per process validation protocol.
Handling all area as per regulatory compliance.
- The candidate should be from Pharma(OSD) Industry only.
- The candidate should Have knowledge and Exposure of GDP/ GMP.
- The candidate should have good communication skills (Verbal & Written)
- The candidate should have Regulatory exposure(USFDA).
- The candidate should be Handling the team of IPQA professionals in his current role.
Interested candidate, Please share the resumes at my mail id email@example.com.