- Review of Batch analytical records for compliance with approved procedures and data authenticity.
- Review of Stability protocols, Stability Reports and, stability samples management records.
- Preparation of analytical trends.
- Review of Quality Control SOP’s (Analytical, Bioassay & Microbiology) and Monitoring of practices and verification of implementation.
- Review of Standard analytical procedure, Test data sheet, summary report and justification reports.
- Preparation of Quality Assurance SOP’s.
- Review of QC & QA investigations
- Issuance and retrieval of documents.
- Escalation of non-conformance in Quality control to Head – QA timely manner.
- Review of Analytical method validation related documents, Protocols, Reports and Analytical raw data.
- Affix master, controlled copy, obsolete, issued by stamp on respective documents and signing.
- Preparation of master list i.e. Master list of SOP’s, Master List of SAP & TDS and Review of master list.
- Review of QMS documents.
- Review of audit trails for QC equipment/instruments
📌 Officer - Analytical QA (Nerul)
🏢 USV
📍 Nerul
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