Quality Assurance Executive

3 days ago

Bavla, India Biotech Vision Care Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Role & responsibilities

  • Perform daily IPQA activities and line clearance in the manufacturing facility.
  • Conduct training for IPQA and production personnel regarding IPQA activities.
  • Review and update artwork/shade cards as per proposed Change Control Note (CCN) details.
  • Oversee language translation processes for documents such as quotations, PR, PO, and final artwork.
  • Monitor plant critical areas for GMP compliance.
  • Prepare and review GMP documents, including SOPs, protocols, and other relevant records.
  • Review executed batch manufacturing/packing records, COA, and analytical data.
  • Manage control sample handling and review stability sample management procedures for compliance.
  • Participate in process validation and cleaning validation activities.
  • Oversee non-conformance handling and ensure compliance in consultation with department heads.
  • Ensure compliance with all QA and plant procedures.
  • Review key documents such as Master Batch Manufacturing Records (BMR/BPR), Master Formula Cards (MFC), QC Specifications,Stability Study Reports, and Annual Product Quality Review (APQR).
  • Support internal and external audits and ensure compliance with audit observations.
  • Ensure fulfillment of all regulatory and market-specific requirements related to products.
  • Ensure compliance with GMP regulations as per ISO, WHO, and CMDCAS standards.

Preferred candidate profile

  • Bachelor's or Masters degree in Pharmacy/Science or a related field.
  • Minimum of 3-5 years of experience in IPQA activities within the injectable pharmaceutical industry.
  • Strong knowledge of GMP, ISO standards.
  • Experience in handling regulatory audits, deviations, CAPA, and change control procedures.
  • Proficiency in documentation and compliance procedures related to pharmaceutical manufacturing.
  • Excellent communication, analytical, and problem-solving skills.

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