Sr Quality Assurance Associate

Responsible for Analytical data review of Stability, Finish Product, Investigations (OOS/OOT/Deviations) .

Handling of Technical agreement, QMS Trending, Self inspections.

Job Description

• Knowledge about ICH, USFDA guidelines &Data integrity principles.
• Knowledge on review of Qualification &calibration of Analytical instruments.
• Technical knowledge on data review for finished product/stability/Raw material samples and analytical method validation/verification
• Having knowledge of quality management system (Change control, CAPA, Incidents, OOS, OOT)
• Experience to handle the internal & external audits.
• Preparation and Review of SOP, laboratory documents like method validation/ verification protocols & reports, SOP’s, Standard Test Procedure & Specification.
• Maintain good documentation practices.
• Participate in Investigation of incident, deviation, OOS, and OOT during analysis.

Education & Experience

• M.Sc. Chemistry/M. Pharm with 6-7 years of related experience.

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.