Knowledge of BET, Environment Monitoring, Sterility, MLT, Culture, Media Preparation. Knowledge of injectable plant aseptic practices, Lyophilization, SVP/LVP Line etc
Handling of medical inquiries / product quality complaints / ADR call receipt, lodging, responding and tracking of inquiries. Tracking of open inquiries and scheduling cases as needed.
Ph.D / MD / MS / MDS or equivalent degree OR three years of research, teaching, design and development after MVSc / M.Pharm / M.E / M.Tech with at least one research paper in Science Citation Index Journal.
Masters / Integrated Masters in Natural or Agricultural or Pharmaceutical Sciences/ MVSc/ Animal Sciences. OR Bachelors degree in Engineering or Technology or Medicine from a recognized University.
Master Degree in Chemistry / Pharmaceutical Science from a recognized university / Institution. M.Sc. or B.Sc. degree with P.G. Diploma in Medical Radio Isotope Technology from BARC.
Responsible for coordination with various departments like Regulatory Affairs, Manufacturing, Warehouse, Quality Assurance, Quality Control, Engineering for execution of Scale-up and Exhibit batches.
Should have good exposure in injectable manufacturing in-process. Manpower handling, Good documentation Practices, should have basic knowledge of machine , Breakdown, operation and troubleshooting during machine operation, QMS, elogbook, Audit exposure.
GCP Subject Matter Expert, Provide independent and objective quality advice in support of clinical trial activities and in line with current standard methodology. Experience in Quality Management, Quality Assurance. pharmaceuticals