4-5

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.

Keep a daily log to document all activities completed each day. Perform duties in compliance with Company’s policies and procedures, including but not limited to those related to HIPAA and compliance.

The candidate must possess a thorough understanding of relevant disease biology, the clinical landscape, emerging technologies, and the competitive environment. The candidate should demonstrate exceptional laboratory technical skills in cell and molecular biology, and, or in vivo pharmacology and proficient at devising strategic solutions to identify and resolve potential challenges.

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.

Setting strategy for evaluating and implementing new technologies within the Analytical Development department, with a particular emphasis on state-of-the-art separation techniques

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

Must be from Parenteral background & exposure to Aseptic vial, Bottle filling process is desirable. To be aware and responsible for achieving quality objective and fulfilling the requirements of applicable quality procedures. Sound technical knowledge of Aseptic area & Controlled area related activities.

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.