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.