Executive - QC

Job Description:

Responsibilities

• To approve analytical COA & test plan in LIMS.
•  Responsible to review Audit trail of laboratory instruments and software like EWS, Empower, LabX etc.
• To release/Approval of the RM/PM in SAP HANA and Analytical technology transfer/validation /development etc.
• Responsible to provide a data of OOS/OOT/Lab Event/FAR/OOC/CAPA/Recall for Quality Council/ R&D Team as applicable.
• Responsible to provide analytical data for annual quality review as applicable.
• Responsible for verification of qualification and training record of Laboratory Analysts.
• Trending of QA observations from raw data review and suggest for improvement.
• Approval of stability protocol, Method Transfer protocol/report, Method Validation Protocol / report, stability summary report.
• To review Pharmacopeia – Evaluation and Equivalence Report.
• To perform the trend analysis of OOS/OOT/Lab Event/QA of QC observation and evaluate the CAPA effectiveness for repetitive Deviation and internal quality observations.
• To actively participate in cross functional investigation.
• Review of regulatory query response.
• To provide technical training with respect laboratory function.
•  Issuance of template/documents /log books etc. 

Qualification & Expeirnece

• Qualification
• M. Pharmacy /B. Pharma , M,Sc chemistry
• Experience
• 10+ years