Biocon - Head - Quality Assurance

Job Scope and Key Responsibilities :

- Setting up the Quality Management Systems for the facility as per the Regulatory Requirements and as per the company policy.

-Strategic planning and scheduling of activities within the department as well as within the cross functional teams.

- Training, mentoring and personal development. Conducting periodic reviews of employee performance.

- Audits (internal and external) and compliance.

- Review of batch documentation (master and executed) and batch disposition.

- Vendor qualification and evaluation.

- Direct and coordinate plant operations within company policies and procedures.

- Prepare annual Quality budgets.

- Regulatory support for filing and providing responses to regulatory and / or customer / partner queries.

- Schedule and conduct meetings with cross functional teams.

- Foster a well-trained and motivated staff.

- Establish and maintain a positive community relationship.

- Statutory requirements compliance.

- Communicate with Subordinates, and Superior on Department operations

- Handling of Quality Management Systems such as Change Controls, Deviations, CAPA, Investigation and Root Cause Analysis, Out of Specifications and Out of Trends, Complaint and Product Recall.

- Identification of training needs and training of personnel in Quality Assurance department.

- Implementation of ISO, cGMP and EHS policies.

- Risk assessment and gap analysis.

- Involve in continuous improvement programs.

- Hiring personnel for the department.

- Annual Product Quality Reviews.

- Stability Programs.

- Working in accordance with management expectation.

- Enable knowledge sharing.

- Customer focus and client / partner relationship.

- Regulatory compliance.

- Validation Master Plan and Quality Manual.

- To communicate relevant QMS, cGMP and EHS issues to concerned personnel.

- To interact with employees regularly to understand the perceptions and opinions on QMS, cGMP and EHS.

- To follow the established procedures and policies of the company pertaining to QMS, cGMP and EHS and report on the performance to the management.

- Other duties as assigned by the reporting Manager.