Assistant Manager
Job Description
• Review of validation documents (Mfg. Process, Cleaning, equipment and water validation etc.) and overall monitoring of validation activities.
• Responsible for Document Data Control.
• Internal Audits.
• Co-ordination with other department for cGMP compliances.
• Responsible for customer audits and its responses.
• Plant Round.
• Preparation and Review of Validation Master plan..
• Preparation and Review of site Master file.
• Review and evaluation of Change control, Deviations and CAPA.
• Handling of Out of Specification, Out of trend and NCR etc..
• Responsible for handling of Market complaints and fulfilment of other marketing requirements.
• Handling of returned goods and product recall.
• Approval of filled batch process records of intermediates and finished products.
• Responsible for batch release.
• Review and approval of standard operating procedure for all departments. Preparation, Review of Quality Assurance SOPs.
• Review of Quality control compliances.
• Reviewing and approval of all BPR/MPR/PQR.
• Review and approval of Equipments qualification.
• Reviewing and approval of all Master specification, method of analysis, protocol and reports.
• Responsible for Vendor Qualification.
• Responsible for approval of approved vendor list and updating.
• Co-ordinate with local FDA for various FDA related works.
• As and when as per requirement other QA works to be done.