Experience – 6-10 of Experience in Molecular Diagnostics or Biotech Division or Pharmaceuticals.
Education – M.Sc. Biotech/ B.Pharm / M Pharm / MSc Chemistry with 6-10 of Experience in Molecular Diagnostics or Biotech Division or Pharmaceuticals.
About Role –
- Verification of Implementation with respect to the cGMP system for manufacturing operations.
- To review all executed quality-related controlled documents like quality procedures, SOPs, BMPRs, specifications, etc.
- To carry out Compliance action post audit.
- To conduct a cross-functional QMS Audit.
- To prepare and implement SOPs pertaining to Common QMS Document and ensure training
- To ensure audit preparation, whenever the Audits are scheduled.
- Implement a change control system
- To ensure that deviations, failures, non-conformances out-of-specification results, and customer complaints are investigated and corrective action is taken.
- To organize internal quality audits and ensure corrective actions are taken on those non-conformances.
- Any other related work.
- Should be well versed with QMS Guidelines