Our client, Recruit AI, is seeking a Quality Control Manager for a pharmaceutical manufacturing facility based in Lahore. The successful candidate will be responsible for overseeing the development, implementation, and maintenance of testing procedures and standard operating procedures (SOPs) related to quality control sampling and testing. This role involves managing laboratory instrument calibration and validation, investigating quality deviations through root cause analysis, and implementing corrective actions. The manager will also coordinate internal and external audits, provide training and mentorship to staff, and work closely with production, research and development, and procurement teams to ensure product quality. Monitoring supplier and raw material quality, maintaining quality records, and reporting key metrics to senior management are essential components of this position. Staying updated on pharmaceutical regulations and industry best practices is critical to maintaining compliance and driving continuous improvement within the quality management system.
Key Responsibilities
- Lead and manage the Quality Control department, supervising a team of five personnel and supporting their professional development and performance.
- Develop, implement, and maintain SOPs for quality control testing of raw materials, in-process samples, and finished products.
- Ensure full compliance with Good Manufacturing Practices (GMP) and ISO 9001 standards across all quality control activities.
- Oversee the calibration, validation, and maintenance of laboratory instruments and equipment to ensure accuracy and reliability in testing.
- Investigate quality deviations, out-of-specification (OOS) results, and customer complaints by conducting thorough root cause analysis and executing corrective and preventive actions (CAPA).
- Prepare, review, and maintain detailed quality documentation, including batch records, audit trails, and reports for internal use as well as regulatory and customer audits.
- Coordinate and lead internal quality audits and actively participate in external audits conducted by regulatory authorities, customers, and certification bodies.
- Train and mentor quality control staff on testing protocols, documentation standards, audit readiness, and regulatory compliance to enhance team effectiveness.
- Collaborate closely with Production, Research and Development (R&D), and Procurement teams to resolve quality-related issues and support process improvements.
- Monitor supplier and raw material quality, assist with vendor qualification, and support ongoing supplier quality assurance to maintain consistency and compliance.
- Report quality metrics and key performance indicators (KPIs), highlighting trends and areas for improvement to senior management for strategic decision-making.
- Stay informed about evolving pharmaceutical quality regulations, standards, and industry best practices to recommend and implement system improvements.
- Lead continuous improvement initiatives aimed at enhancing efficiency, effectiveness, and compliance within the quality control function.
Required Qualifications
- Proven experience in quality control management within pharmaceutical manufacturing.
- Strong knowledge of GMP, ISO 9001, and relevant pharmaceutical regulatory requirements.
- Demonstrated ability to develop and maintain SOPs and quality documentation.
- Experience in laboratory instrument calibration, validation, and maintenance.
- Skilled in conducting root cause analysis and implementing CAPA.
- Ability to lead and mentor a quality control team effectively.
- Experience coordinating internal and external audits.
- Excellent communication and cross-functional collaboration skills.
- Proficiency in monitoring supplier quality and vendor qualification processes.
Preferred Qualifications and Benefits
- Advanced degree or certification in pharmaceutical sciences, chemistry, or related fields is preferred.
- Experience with continuous improvement methodologies such as Six Sigma or Lean.
- Exposure to quality management software and electronic documentation systems.
- Opportunity to work in a dynamic pharmaceutical manufacturing environment with a focus on quality excellence.
- Professional growth through ongoing training and development initiatives.
This role offers a challenging and rewarding opportunity to contribute to the quality assurance framework of a leading pharmaceutical manufacturer while working alongside multidisciplinary teams to ensure product safety and compliance.