After a journey of growth spanning 27 years as Cadila Healthcare Ltd. and the Zydus Group, we have evolved and transformed ourselves in response to the changing times.
Centaur Pharmaceuticals one of the rapidly growing Pharmaceuticals Company in India. Centaur Pharmaceuticals is USFDA and MHRA approved plant is seeking deserving candidates having experience working in Oral Solid Dosage Manufacturing facilities for regulatory market's.
Plan, execute & ensure timely submission of various applications when assigned including but not limited to only these: test license application, HAQ response submission, CT updates and notification submission e.g. IB amendment, site closure, site addition, EC approval submission etc.
Masters or Ph.D. in Biotechnology, Genomic Science, Biochemistry, Bioinformatics, Biomedical, Bioprocessing with a strong technical knowledge in the respective core domain and passion for life science-related industry segments.
The ideal candidate will have advanced Excel skills and a background in Pharmacovigilance and Safety Operations or Research and Development. This hybrid role requires rotational shifts and offers an opportunity to make a significant impact on our projects and society.
Must have worked in regulated plants having approvals of USFDA, MHRA. etc. Hands-on experience in handling and implementing cGMP Current Good Manufacturing Practice practices and Good Documentation Practices
Execute Analytical method Validation activities of drug substances API by using HPLC,GC and Spectroscopic techniques as per regulatory guidelines. Execution and coordination for Analytical method transfer activities of drug substances.
Candidate should have experience in Oral formulations Solid and liquid for Handling of IPQA, APQR activity and Process Validation. Candidates must have experience in review of Analytical Document, Investigating out-of-specification results, and ensuring adherence to GMP guidelines.
Monitoring CAPA till completion, Management of lateness documentation form, identify the Deviation Owner, Follow-up in case of no response, Identify potential critical and major systemic deviation and escalate as required. Identify Trends during ongoing investigations and as part of retrospective reviews.
Achieve Division wise primary target and ensure it to be equal to or greater than Secondary. Generate maximum prescriptions & increase market share. Ensure zero cases of expiry on Stockist shelf by timely liquidation of stocks by prescription generation.