Job for M.Pharm, M.Sc as General Manager-QA (Biologics) in Biocon

Biocon is a research-driven, global healthcare company with a strong matrix of capabilities along the biopharmaceutical value chain. Focusing on unmet medical needs in cancer, diabetes and inflammatory diseases, it offers novel therapies on a platform of affordable innovation.
Biocon together with group companies employs more than 2500 employees with approxmimately Rs 1,000 crore turnover and is expected to grow further during the current financial year.

Post: General Manager-QA (Biologics) - HC/JC/3062/2013

Job Description:
1.Direct activities within QA and QC in alignment with the Company Quality Policy to ensure that manufactured products meet regulatory expectations and company standards.
2.Proactively prepare for and manage PAI and other Health Authority inspections, response preparation and CAPA as appropriate by assuring that the site is operating in an “inspection- ready” manner at all times.
3.Develop strategic goals and objectives to support the monitoring, review, testing and timely reporting on the quality of biologics drug substances.
4.Lead, coach, guide as well as manage performance and development of the members of the Quality Unit to achieve organizational goals and employee personal and professional growth.
5. Manage and administer people processes including provide training of personnel on company and department policies systems and processes.
6. Communicate significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive Management.
7. Build and maintain strong partnership with partner company quality leads to assure mutually successful Working relationships.
8. Perform any other tasks as requested by Executive Management to support Quality oversight activities

Skills
1.Direct activities within QA and QC in alignment with the Company Quality Policy to ensure that manufactured products meet regulatory expectations and company standards.
2.Proactively prepare for and manage PAI and other Health Authority inspections, response preparation and CAPA as appropriate by assuring that the site is operating in an “inspection- ready” manner at all times.
3. Develop strategic goals and objectives to support the monitoring, review, testing and timely reporting on the quality of biologics drug substances .
4.Lead, coach, guide as well as manage performance and development of the members of the Quality Unit to achieve organizational goals and employee personal and professional growth.
5. Manage and administer people processes including provide training of personnel on company and department policies systems and processes.
6. Communicate significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive Management.
7. Build and maintain strong partnership with partner company quality leads to assure mutually successful Working relationships.

Additional Information:
Experience: 15-20 Years
Location: Bangalore
Education: M.Pharm, M.Sc
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QA
End Date: 30^th Nov., 2013