Quality Assurance Assistant Manager

Job Description Summary

To Support the Analytical Laboratory, Preparation and review of SOP and its updation, Review of all QMS documents. Review of ROA, Calibration reports, IQ, OQ, PQ reports. Review of Tech transfer, Analytical validation document. Review of Stability Protocol, Stability reports and stability trend data. To ensure Compliance of Safety precaution & cGMP in Analytical Laboratory. Maintaining all Calibration & preventive maintenance Schedule. Assists in audits & preparations of Audit compliance reports. Handling and maintaining of all training records. Responsible for review of OOS, OOT, Incidents, Deviations, CAPA and Change control.
Part of investigation team for investigation of OOS, OOT, Incidents of Analytical lab

Job Description

Job Description :-

• SOP preparation & its Updation.
• Reviewing of all QMS documents like change control and investigation for OOS/OOT, incident/deviation.
• Reviewing of Tech transfer and Analytical Validation/verification data. 
• Responsible for conducting the Internal Audit as per schedule and Audit compliance reports.
• Ensuring compliance of all SOP and system implementation
• Reviewing of Stability Protocol, Reports & Trends data, Responsible for review of all analytical instrument (HPLC, LCMS, GCMS, GC, UPLC, UV, IR etc.) calibration records.
• Basic understanding of GMP, Review of standard testing procedure, specification and record of analysis.
• Experience on Risk assesment and Gap assesment.
• SOP , QMS and issuance of formats,& documentation for Analytical Laboratory
• Maintaining Documentation room.
• Documentation support for Analytical Lab.
• Technical support for Analytical Lab

Education & Experience :-

• Bachelors/Masters in relevant stream
• 8 to 12 years of 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.