OQ Officer

Site Name: Pakistan - Sindh - Karachi

Posted Date: Sep 24 2024

Job Purpose

To ensure that products are manufactured, stored, and released in compliance with applicable standard procedures and GMP guidelines, while maintaining quality oversight throughout the process.

Education, Experience & Skills

• MSc in Chemistry Sciences/ Pharm-D
• 2-3 year experience in Pharmaceutical Quality Assurance department particularly in IPC of Non-Sterile production operations.
• Strong knowledge of Quality Assurance (QA) principles in the pharmaceutical industry.
• In-depth understanding of GMP and EHS compliance.
• Proficiency in In-Process Controls (IPC) and batch documentation.
• Familiarity with auditing processes and CAPA implementation.
• Ability to conduct root cause investigations and contribute to continuous improvement. Preference will be given to candidates holding a Lean Six Sigma Yellow or Green Belt certification.
• Excellent communication and teamwork skills to collaborate with cross-functional teams.
• Strong organizational and time management skills with attention to detail.
• Knowledge of Quality Management Systems (QMS) and Quality Risk Management
  
  
  

Key Responsibilities

• Ensure quality oversight during the production operations (Dispensing, Manufacturing, Packaging, Release) and ensure that products are manufactured, stored, and released in accordance with defined procedures, quality standards, and specifications.
• Ensure adherence to GMP (Good Manufacturing Practices) and EHS (Environmental, Health, and Safety) standards during operations.
• Collaborate with cross-functional teams such as production, engineering, and validation to address quality issues and ensure continuous improvement.
• Support the FLL Operational Quality (OQ) team in managing day-to-day quality activities and implementing site-wide strategies within the scope of the Quality function.
• Engage actively in internal and external audits and ensure corrective and preventive actions (CAPAs) are implemented promptly.
• Conduct in-process controls (IPC), area line clearance, and challenge tests during production operations.
• Ensure timely and accurate batch document compilation, perform a comprehensive review, and support the FLL OQ in the batch release process.
• Participate in investigations of manufacturing deviations, customer complaints, and quality-related issues to ensure effective resolution and continuous improvement.
• Provide expertise and input into the development of quality risk management (QRM), and conduct impact assessments as necessary for changes or deviations.
• Support the continuous improvement of Quality Management Systems (QMS) by suggesting procedural updates based on operational findings and regulatory changes.
  
  
  

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Contact information:

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