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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

Conduct preliminary review of laboratory results relative to established protocol-specific reference range guidelines, using relevant clinical laboratory experience and compares current results with prior laboratory values to evaluate or note clinically significant increases, decreases and contacts the investigator site for pertinent additional clinical contact for distribution to project team

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