Biocon - DGM/GM - Quality Control - Microbiology

Designation : DGM / GM

Department : QC - Microbiology

Areas Handled : Overall Management of Quality Control Microbiology activities across all sites.

Products / Documents to be handled :

- APIs, Biologicals & Biosimilars DS+DP- Finished product, Raw materials, In-Process and Quality control records/documents

Key Responsibilities :

- Directing quality control microbiology activities.

- Interaction with production, RND, Regulatory and other cross functional departments for better functioning of Quality Control-Microbiology.

- Interaction with EHS department for Lab/personnel safety.

- Responsible to take decisions relating to product recalls and serious complaints and ensure that the appropriate follow up measures are taken.

- Leading a team of quality professionals, which includes supervision of all aspects of the employee performance management life cycle including hiring, development planning & performance management.

- Ensuring that the right skills and capabilities of people in the quality department are developed to enable the organization to be flexible/adapt to the dynamic business conditions.

- Responsible for implementation of Quality culture within the organization by providing operational quality oversight. Ensure that the potential gaps and risks are addressed and opportunities for continuous improvement identified during quality reviews.

- Ensuring site readiness for regulatory inspections and support sites during inspections. Responsible to provide effective quality leadership during internal and regulatory inspections.

- Communicate Quality Systems throughout the organization to ensure up to date regulatory compliance.

- Budgeting for Quality control department and interactions with suppliers/vendors for procurement.

- Review of Quality control : Microbiology documents and other relevant documents from cross functional teams.

- Organizing cross functional team audits.

- Responsible for leading Microbiology projects inclusive LIMS, KAIZEN, 6 sigma and continuous improvement of Rapid Microbiology Methods.

- Coaching and Mentoring

- Harmonization of Microbiological activities

- Sponsoring of Initiatives

- Review of Risk Assessment studies

- Assessing gap in regulatory requirement and industrial bench marked aseptic practices.

Secondary Responsibilities:

- Preparation of audit reports.

- Execution of trainings on quality system

- Support for material procurement

- Failure investigations