Chemical QA Executive - Vadodara, India - ANNEXE CHEM PVT LTD

ANNEXE CHEM PVT LTD

Verified Company

Vadodara, India

2 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

To assist External Inspector/Auditors while inspection throughout the inspection.

Participating in Vendor Audits and preparing the assessment audit reports.
Performing Internal Audits of QC lab, Manufacturing Plants, Warehouse for RM and finish
To perform in process Audits, I.e. Finished product release, manufacturing process etc.
Review of SOP for QA, STPs and AWRs of finished product from QC, Batch manufacturing
Drafting documents for Drug Master File.
Maintain reference samples and its record for its retest period.
Maintain QMS documentation likewise deviation, change controls, release of finished goods,
Management of customer's audit, VQ and related documents submission. Submission of audit

- response report & finally compliance report for customer audit.

Handling stability study and hold time study programme.
Review of annual product quality review.
Review of audit trail of QC instruments.
Making summary of final product result for trending of result.
Preparer of cleaning validation protocol and report prepared by production department.
Sampling & Testing of all inward raw material & packaging materials as per specifications.
Maintaining identification & traceability for all material in stores & plant.
Calibration & operation of all instruments like HPLC, Melting Point apparatus, pH meter,
Conducting lab trials for trouble shooting or specific quality improvements as per required by
Conducting lab trials for trouble shooting and product development.