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: Associate Manager- QA Biologics - HC/JC/3167/2013
Job Description:
1.Responsible for Quality Assurance activities related to commissioning, qualification and validation of Facilities & Equipment of Biological manufacturing & testing facilities.
2.Ensuring compliance to procedures, regulations and cGMP in the areas of equipment qualification.
3.Ensuring the design compliance of expansion project at Biocon.
4.Review and approval of GMP related process & QC documents like
a] Calibration and preventive maintenance systems.
b] Master layouts and drawings etc.
c] Deviation, OOS and Change Control related to equipment and facilities
5.Manage the implementation of Biocon Quality Manual and Biocon policies throughout the production site to ensure quality processes are maintained to ensure compliance with regulatory standards.
6.Drive the GMP operations team to continuously improve quality management.
7.Ensure preparation and delivery of relevant Validation Plans.
Skills:
8 years experience in Biotech (Biotech Manufacturing/Qualification/Projects). With 2-3 years in projects/ qualification or related role.
2. Minimum 2-3 years’ experience in leading a team.
3.Good understanding of Engineering fundamentals and instrumentation.
4.Provides quality talent management through performance management and training, in order to meet strategic and operational objectives.
Additional Information:
Experience: 2-3 Years
Location: Bangalore
Education: M.Pharm, M.Sc Life Sciences
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QA
End Date: 30th Nov., 2013
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