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.RoleQA / QC Manager
  Industry TypePharmaceutical & Life Sciences

  Functional AreaQuality Assurance

  Employment TypeFull Time, Permanent

  Role CategoryProduction & Manufacturing
  Education

  UG :B.Pharma in Any Specialization

  PG :MS/M.Sc(Science) in Chemistry
  Key Skills

  1. Corporate Quality Assurance 2. Training 3. SOP 4. QMS 5. Compliance Management