Panacea Biotec - Leadership Role - Quality Control - Vaccine

Tasks / Responsibilities:

- Responsible for Overall QC activity including bench operations

- Implementation of QMS as per WHO cGMP

- Propose new quality systems to improve the quality parameters and overall improvement in methods

- To lead the entire quality control team at the site

- Ensuring authorization of written procedures and other documents, including amendments

- Ensuring monitoring and control of the manufacturing environment

- Ensuring process validation and calibration of analytical apparatus

- Ensuring training, including the application and principles of quality assurance

- Ensuring designation and monitoring of storage conditions for materials and products

- Ensuring performance and evaluation of in-process controls

- To ensure good documentation practice of testing is carried out across the lab

- Improve existing prediction methods

- Find new approaches to measure quality attributes

- Improve estimation tools to handle complexity

- Cost effectiveness & Quality

- cGMP training

- SOP compliance

- Audit of facility for compliance

- Line clearance

- In-process counter checks

- Critical sampling

- Record verification

- Release of batch for marketing

- Investigation of market complaints

- Cost Benefit Software

- Online processes for testing etc

Essential Requirement:

Thorough knowledge of following subjects:

- Microbiology : EMP, sterility, endotoxin testing, water testing, bacterial identification tests.

- Wet chemistry and instrument analysis, knowledge of HPLC, spectrophotometers, polarimeter etc.

- Bio-assays, potency testing reference standard preparation and testing

- Stability testing and stability indicating parameters

- Analytical method validation and cleaning validation

- Sampling process

Ideal Incumbent Profile:

Qualification: M.Sc. and Ph.D. Biotechnology / Biochemistry / Microbiology/ Chemistry/Life Sciences/related field

Age: upto 40 years

Experience: Minimum 12 to 15 years relevant experience in pharmaceutical sterile bulk antigens (Biologicals)

Preferred Industry: Any reputed Pharmaceutical

Desirable Profile for GM-QC Position- Incumbent should have experience in:

- Tissue culture based Vaccine Testing-Cell/Tissue Culture

- Sterility Testing- Exposure to microbiology in QC

- Stability/Potency testing of Viral/Bacterial Vaccines

- Vaccine RM (Excipient)/PM Testing

- EMP of Clean Room