5++

Responsible for ensuring cGMP compliance in the QC laboratory, reviewing analytical documentation, and approving Certificates of Analysis for all materials and products.

Masters degree in Pharmacy or Clinical research. Plan and perform vendor qualification and audits for pre-clinical, clinical, and In-vitro studies service providers.

To manage and strengthen relationships with regulatory and government bodies, ensure compliance with licensing and regulatory requirements, WHO-GMP standards for plants and warehouses in the assigned region, and lead Corporate Social Responsibility

Lead and mentor the global case processing team, fostering a collaborative and high-performance culture. Oversee daily operations, ensuring timely and accurate processing of adverse event reports.

AVP will lead Amgen’s Clinical Data Management function within GDO, ensuring the highest quality of clinical data collection, processing, and analysis to support regulatory submissions and clinical development programs.

Results-oriented professional with progressive experience in Sales and Marketing, driving revenue growth and business expansion. Proficient in developing comprehensive account strategies by leveraging market insights, defining value propositions, and implementing actionable business plans.

Responsible for preparation & review of the master documents of sterile manufacturing department and warehouse department for Parenteral facility.

Facilitate and manage corporate quality audits and regulatory audits and drive the Supplier Qualification Program, including the identification, evaluation through audits, monitoring, maintenance, and re-qualification of vendors.

Proven track record of leading a large, geographically diverse sales team, including at least 2 years of experience overseeing half of India with consistent performance, growth and positive P&L outcome.