Deputy Manager

Symbio Generics; Bengaluru; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Symbio Generics in Bengaluru is seeking a QA/regulatory professional to oversee SOPs and review vendor qualifications, APIs, excipients, and formulation development documents. The role includes coordinating technology transfer, validation protocols, DMF documentation, and ensuring audit readiness.

You will conduct routine GMP-compliant inspections and collaborate with cross-functional teams to ensure timely formulation, validation, and quality activities across sites.

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

Roles and 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