Job openings @ Biocon
Department: Quality Assurance (Central Compliance)
Qualification: B.Pharm/ M.Pharm
Experience: 12 – 16 years
Job Location: Bangalore
Job role – Central Compliance
- Implementation of company’s Quality policy and GMP Regulations at all sites.
- Overall monitoring of quality activities in the area of operation.
- Coordinating with team members for achieving quality requirements.
- Conduct internal GMP rounds, review of gaps and implementation of action plan.
- Implementation of compliance actions towards Health authority observations from various audits on other industries at Biocon
- Handling of Customer / Regulatory Audits, preparation and implementation of CAPA
- Handling of Vendor audits.
- Preparation and approval of QMS procedures at corporate
- Review of Investigations – OOS, OOT, Deviations, Complaints, Recalls
- Change management and CAPA management at Corporate
- Review of Validation documents for Process, Methods and Cleaning
- Design and commissioning of facilities
- Review and implementation of Equipment qualifications and CSV
- Training of company personnel in Quality Management Systems.
- Implementation and monitoring of Data integrity practices
- Engage in various consultant activities for compliance management
- Implementation of lean management, operational excellence and statistical process control strategies and projects
- Implementation and monitoring of enterprise level quality management projects.