Deputy Manager - DQA Formulation

Role

Deputy Manager for DQA role, responsible for overseeing QA activities related to formulation, validation, technology transfer, QMS, vendor qualification, and audit readiness.
The role requires strong cross-functional coordination, hands-on QA oversight at manufacturing sites, and willingness to travel to other sites for audits, inspections, and quality activities.

Job Description:

• Preparation, review, and revision of Standard Operating Procedures (SOPS) related to formulation activities
• Review of vendor qualification and technical documents for APIs and excipients.
• Review of formulation development documents for pellets, granules, and finished products.
• Review and implementation of technology transfer activities for formulation products.
• Review of process validation and cleaning validation protocols and reports for pellets and granules.
• Review of hold-time study and stability study protocols, reports, and related documentation.
• Planning and conducting vendor audits for APIs and excipients, as applicable.
• Review of Quality Management System (QMS) documentation and its implementation at manufacturing sites.
• Review and support in the preparation and compilation of Drug Master File (DMF) documentation.
• Ensuring audit readiness by coordinating document review and providing necessary support prior to regulatory, customer, and internal audits.
• Conducting regular routine inspections of the manufacturing plant to ensure compliance with applicable GMP requirements, approved procedures, and established quality standards.
• Coordination with cross-functional departments to ensure timely completion of formulation, validation, technology transfer, and quality-related activities