Team Member QC - Roorkee

Job Purpose

Prepare, update and review the specifications, SOPs, policy and operating documents for analysis of materials in order to ensure alignment to predefined quality parameters and compliance to respective standards / pharmacopeia and cGMP requirements

Accountabilities

• Ensure Lead time for releases at LL Sites by analyzing route cause for increased lead time to give release on time. Ensure the OTIF at LL/P2P sites against SLA
• Review of SAP details & follow up with sites for analysis/release/COA uploading in SAP/UD in SAP.
• Review and arrange the requirements for in house analysis at CMOs.
• Propose unit management for procurement of Requirements for in-house analysis.
• Review analysis lead-time of LL sites for RM/PM/FP through QC Register and Preparation of data of lead time/OTIF of LL/P2P sites
• Analysis monitoring of Validation Batches at sites & submission of summary results to TPQ team
• Analysis witness of P2P products & stability data review for products approval
• Analysis witness for results verification/OOS/OOT/market complaint samples and OOS/OOT of stability samples at sites/PTL also
• Random Analysis monitoring during visit at sites
• Analytical reports review of RM/PM/FP and stability studies also at sites

Education Qualification

M. Sc. / B. Pharma

Relevant Work Experience

5-8 years of experience in QC department of a pharmaceutical organization

Job Location

Roorkee