AQA – API | Alembic Pharma | Vadodara

Job Description

Executive / Senior Executive / AM – Analytical Quality Assurance – API

Roles and Responsibilities

  • Review & Approval of Analytical Method Validation Protocols, method data & reports.
  • Handling of Incidences & Deviations.
  • Root cause Investigations & Corrective, Preventive action execution.
  • GLP Audits, Data integrity & Lab compliance.
  • Life Cycle Management of Analytical Method.
  • Review of SOPs, STPs & Specifications.
  • Outsource API DMF review & Vendor Qualification.
  • IQ-OQ-PQ-DQ Documentation.
  • Demonstrated competence in Analytical & Instrumental troubleshooting.
  • Other QMS-relevant activities like change controls/deviations / OOS and OOT etc.
  • Awareness of ICH Q7 / WHO GMP and ISO-9001:2008 guidelines.

Qualification & Experience

  • M.Sc. (Chemistry)
  • 05 to 10 years of relevant experience.

Desired Candidate Profile

  • Candidate must have good exposure to working with API industries.
  • Should be strong in all areas of communication & documentation
  • Should have worked in AQA dept. for at least more than 5 years.

Qualification: MS/M.Sc Chemistry

Location