Executive - Quality Assurance (IPC)

2 weeks ago

Karachi, Sindh, Pakistan Getz Pharma Full time 900,000 - 1,200,000 per year

Position Summary:

Executive – QA (In-Process Control) is responsible for performing line clearance, in-process checks, and real-time quality monitoring during manufacturing and packaging operations across Oral Solid Dosage (OSD), Sterile, and Dry Powder Suspension areas. The role ensures compliance with cGMP, WHO, ICH, and PIC/S guidelines, contributing to continuous improvement and maintaining the integrity of manufacturing processes.

Key Responsibilities:

  • Perform line clearance and in-process checks in manufacturing and packing areas (OSD, Sterile, Primary, Secondary, and Dry Powder Suspension) to ensure compliance with approved procedures and regulatory standards.
  • Monitor critical process parameters and product quality attributes during manufacturing to ensure adherence to batch manufacturing records (BMR/BPR) and SOPs.
  • Ensure timely and accurate reporting of deviations, non-conformances, and non-compliance with SOPs or GMP standards; initiate and support deviation investigations.
  • Identify process gaps and non-conformities; assist in the implementation of corrective and preventive actions (CAPA) and follow-ups to prevent recurrence.
  • Participate in timely revision and preparation of SOPs, protocols, formats, and other quality documents as per regulatory and organizational requirements.
  • Ensure compliance with the approved product sampling plan during various stages of the manufacturing process as per SOPs and regulatory guidelines.
  • Verify and ensure that batch documentation is completed in a timely and accurate manner.
  • Assist in GMP audits, self-inspections, and support regulatory inspections by providing required documents and clarifications.
  • Maintain up-to-date knowledge of WHO, ICH, and PIC/S guidelines and ensure implementation in day-to-day operations.

Knowledge, Skills, and Qualifications:

  • Pharm - D / M.Sc. in Chemistry / Applied Chemistry or related discipline.
  • years of experience in QA (In-Process control) in a regulated pharmaceutical manufacturing environment, preferably with exposure to OSD, Sterile, and suspension dosage forms.
  • Sound understanding of cGMP, WHO, ICH, and PIC/S guidelines.
  • Proficient in conducting process validation monitoring and ensuring in-process control parameters comply with regulatory expectations.
  • Skilled in data integrity principles to ensure accurate and complete documentation consistent with ALCOA+ standards.
  • Hands-on experience in line clearance, in-process checks, and GMP documentation.
  • Familiarity with manufacturing processes and equipment used in OSD and sterile production.
  • Strong observational and problem-solving skills.
  • Good documentation and communication abilities.
  • Ability to work collaboratively with cross-functional teams.

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