Deputy Manager - DQA Formulation

Symbio Generics; Jigani; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Symbio Generics invites applications for Deputy Manager, DQA, overseeing QA activities across formulation, validation, technology transfer, QMS, vendor qualification and audit readiness. Role involves hands-on QA oversight at manufacturing sites and travel to other sites for audits and quality activities.

Candidate will coordinate with cross-functional teams to ensure timely completion of formulation, validation, technology transfer, and quality-related activities, while ensuring GMP compliance

Responsibilities

• 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

Job description

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