Senior Officer
Job Description
• Preparation of Certificate of Analysis (COA) according to released activity completed every month as per dispatched plan
• Prepare inspection plan as per specification in SAP.
• Prepare COA as per Specification/RA and Customer requirement and also enter data in SAP.
• Responsible for releasing or rejecting of finished drug substance in SAP.
• Regular follow-up with QC personnel and coordination to ensure of Release activity.
• Plant Rounds.
• Issuance of documents to all departments.
• General documentation & co-ordination with other departments for cGMP compliance.
• Internal and external audit related works
• Preparation of finished products label
• Preparation of release label and released the material during material dispatch
• Purchase order verification
• Release of finished goods in SAP
• Preparation of certificate of analysis of finished goods
• Review of filled batch process records
• Review of filled batch process records of intermediate and SRP.
• Review of filled batch process records of finished product.
• Review of master batch process record of intermediates and SRP.
• Monitoring of finished product packing and labelling.