Biocon - Head - Quality Assurance - Injectable

Key Responsibilities:

- To ensure that processes needed for the quality management system are established, implemented and maintained.

- Reporting to management on the performance of the quality management system and any need for improvement.

- Ensuring the promotion of awareness of regulatory and customer requirements in the organization.

- Liaison with external parties (including International and National Regulatory authorities) on quality management system related matters.

- Budgeting for QA Department.

- Implementation of company's Quality policy and GMP Regulations.

- Overall monitoring of quality activities in the area of operation.

- Review of internal GMP rounds report / inspection outcome and review of action plan in all the sites.

- Overall responsibility for batch/product release.

- Internal Quality System Audit for Biocon.

- Evaluation of Good manufacturing practice and Good Laboratory Practices in Biocon.

- Handling of Customer / Regulatory Audits.

- Handling of Vendor audits

- Handling of Contract manufacture site Audits.

- Review of audit reports and CAPA response reports.

- Review of Internal Audit Reports.

- Response to queries and deficiencies.

- Review and resolution of customer complaints.

- Handling of Product Recalls.

- Approval of Annual product Report

- Review and Approval of Out of Specification.

- Review and Approval of Out of Trends.

- Investigation of deviation, batch failure and final disposition.

- Recruitment of personnel.

- Training of company personnel in Quality Management Systems.

- Review of Quality Manual and Master Validation Plan.

- Review and approval of TTDs, Quality Agreements, Validation, qualification documents and other Quality Documents.

- Review of quality control records.

- Review of product specifications and analytical reports

- Adherence to product specifications

- Review of analytical method validation protocols and reports.

- Investigation of OOS results.

- Issue of raw data book/checklists/log sheets for record entries.

- Authority to handle complaints related to quality of the product (Customer as well as regulatory bodies).

- Review of cleaning /Process validation protocols and reports.

- Investigation and authorization of laboratory incidents.

- Effective implementation of Environment, health and safety in department.