Biocon - Head/General Manager - Quality Assurance - Biologics

Key Responsibilities :

- Establish and maintain the global quality system standards for Biologics manufacturing sites.

- Ensure Quality Oversight on all Manufacturing sites of Biologics, to ensure consistency of global standards, harmonization, sharing of best practice and productivity.

- Operational lead of Biologics QA unit staff.

- Ensure qualified personnel are available in QA operations.

- Drive continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements.

- Conduct Quality Reviews to evaluate if processes and deliverables fulfil the requirements for quality, to uncover errors or deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement.

- Support the development and delivery of training in quality matters.

- Interface with business Units to ensure Quality operations and practices are aligned with regulatory expectations and industry best practices.

- Prepare and follow internal authority inspections.

- Oversee deviations, investigations and audits.

- Interact heavily with manufacturing plants, making sure products are getting released on time and within compliance.

- Handle customer issues.

- Involved in regulatory and customer audits.

- Work within a group, work heavily across multiple sites and work within a very collaborative type culture.

- Develop and motivate team.

Desired Skills & Experience :

- Candidate should be a Post Graduate in Life-sciences / Doctorate in Life Sciences with over 15 years of experience in handling the Quality Assurance in Biologics leading a mid / large team.