AGM/DGM - Quality Assurance - Pharma - Formulation

Third party audits, International and domestic Vendor audit (Packaging materials, Excipients, LL, P2P and APIs) vendor qualification.

- Knowledge of Documentation activities for cGMP and Regulatory compliance.

- Have effective communication skill and willing to share information and contribute my best efforts to ensure the achievement of team objectives.

- Conducting audit of manufacturing plants and Vendors supplying excipients and packing materials.

- Planning, Preparing, Conducting and Reporting of GMP/Quality audits.

- Writing Audit Reports.

- Evaluation of audit result for the audits done.

- Maintenance of audit data in a related data system.

- Participation in internal and regulatory audits as required.

- Preparation and exercising the sent and received Quality agreements.

- Knowledge of General QA/QC documentation, QC Specifications, raw materials & Finished Product Stability documents.

- Knowledge of reviewing Dossiers for the components being used for regulatory, CIS and emerging markets and always have interest to have information in coordination with RA dept.

- Good understanding and review on BMRs, BPRs, process validation data for regulatory, CIS and emerging markets.

- Writing/revision of SOPs as and when required.

- Process Validation as per validation protocols.

Call at 9849006750
Ravi Kumar
Director