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Sr. Executive - Technical Cell For Akums ( Haridwar ) Akums Drugs and Pharmaceuticals


 Location: Haridwar

Experience: 6 to 10 Years


Job description

  • Review of Quality Management systems like, Change controls, Deviations, Incidents and CAPA, OOS, OOT, Quality Risk Management, VMP, SMF, PQR, Cleaning validation, Product/ Mock Recalls, etc.
  • Review of Quality Management Review Meetings observations and CAPA.
  • Review BMR/BPR/PPQ/PQR/Hold time studies/ Technical agreements.
  • To ensure the integrity of all data generated either manually or electronically.
  • Review of SAP and other IT-related procedures.
  • Review Sterile Injectable, Ophthalmic, Micro, Liquid, Ointments & OSD Operations.
  • System, Operations, Practices & Documents Harmonization.
  • Coordination with all sites Formulation for Compliance, Meeting & Trainings.
  • Review the Sanitization & Hygiene practices & Formulation/ Sterile activities.
  • Third-party, LL, RM/PM Vendor, Contract Testing Lab. Audits, Site Audits & compliance verification.
  • Support for various regulatory and customer audits.
  • Ensure all-time audit readiness and identify and assessment/implement changes to improve the quality of products, processes & services.
  • Provide training to staff on GLP, GMP, GDP and SOPs.
  • Review MRM observations and compliance.QA / QC Manager
    Quality Assurance
    Full Time, Permanent
    Production & Manufacturing
    Education
    B.Pharma in Any Specialization
    MS/M.Sc(Science) in Chemistry
    Key Skills
    1. Corporate Quality Assurance 2. Training 3. SOP 4. QMS 5. Compliance Management
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