Pharmacy or Biological Science Graduate, Post graduate. 10 to 15 years of field work experience in pharma Industry Preferably 1 year as a training manager in field or in corporate
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Post : Study Data Manager, Pharmacovigilance, Clinical Operations
B.Pharm, M.Pharm candidate having 4-10 years of experience. The job requires knowledge of MFG of batch as per procedure with proper documentation, perform line clearance of equipment and area, ensure proper handling and correct usage of respective process materials
Must have handled critical equipment like reactor, centrifuge, blender, sifter, multi-mill, etc. Ensure that the products are manufactured as per the cGMP.
Prepare and execute of Process validation, Hold time study protocol and compilation of Process validation reports. To monitor Equipment Qualification, HVAC and Utility validation schedule as per VMP.
Execution of analytical method optimization, development, validation, verification of analytical test methods related to Compendia, In-house developed methods, Site transfer methods, Regulatory queries, Method Life Cycle Management studies, Supplier Driven Changes and other procedural updations.Preparation of method validation/verification protocols and reports.
Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment internally and with external partners. Demonstrated learning agility, and ability to think creatively, try new ideas and apply learnings and strong problem-solving skills.
Proven track record of documentation review for accuracy and compliance to procedures essentially in analytical methods development, validation, transfer, stability studies, Design & Development.