QA

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.

M. Pharm Pharmaceutical Quality Assurance, Pharmaceutics, Industrial Pharmacy and Ph.D. in relevant discipline, preferably in Pharmaceutical Quality Assurance. fresh and experienced; good track record of publications, patents, grants

B.Pharm, M.Pharm, M.Sc, B.E. with 2 to 10 Years of relevant experience of IPQA, Qualification, QMS, Sterility Assurance, QA IT related activities in Injectable Manufacturing Plant.

Audit Response writing skill, Audit handling skill. Current Guideline assessment and compliance. Gap Assessment to overall Regulatory Compliance. Proficient in risk assessment, cleaning procedure optimization. Adept at collaborating with cross-functional teams to maintain robust cleaning validation programs.

Have good exposure in Plant Maintenance & Instrumentation related work in sterile facility. Have good exposure in Sterile IPQA & Sterile Qualification Related activity.

As per the batch manufacturing procedures and packing protocols, samples such as in-process samples, finished product samples, stability samples, control samples, cleaning samples, and other samples should be collected and submitted

Having Injectable Experience of Analysis of raw material. In-process, Finish products, Stability testing, Process validation. Hands on Experience of HPLC, GC, LBPC, Osmometer, KF Auto titrator and UV - Visible spectrometer, LIMS,QMS,Participate in Lab incident , OOS, OOT, Analysis of deviation.

Intas is expanding and evolving its Biopharmaceutical capabilities. We invite ambitious professionals to be a part of its future growth story.

 IPQA Mfg. & Packing, Shop floor activities, Review of equipment audit trails, BMR, BPR review, line clearance. Process Validation, equipment, Utility qualification.