Our client, Recruit AI, is seeking a Quality Control Manager for the pharmaceutical industry based in Lahore. The Quality Control Manager will play a pivotal role in developing, implementing, and maintaining testing procedures and standard operating procedures (SOPs) to ensure the highest quality standards. This position involves managing laboratory instrument calibration and validation, investigating quality deviations through root cause analysis, and implementing corrective actions. The role also requires coordinating internal and external audits, training and mentoring the quality control team, and collaborating with production, research and development, and procurement departments. The manager will monitor supplier and raw material quality, maintain comprehensive quality records and audit trails, and report key quality metrics to senior management. Staying updated with evolving pharmaceutical regulations and industry best practices is essential to maintain compliance and drive continuous improvement within the quality management system.
Key Responsibilities
- Lead and manage the Quality Control department, supervising a team of five personnel and fostering their professional growth and performance.
- Develop, implement, and maintain SOPs for quality control testing of raw materials, in-process samples, and finished products.
- Ensure strict 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 guarantee accurate and reliable testing results.
- 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, batch records, audit trails, and reports required for internal use, regulatory inspections, 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 address quality-related issues, resolve discrepancies, and support process improvements.
- Monitor supplier and raw material quality, support vendor qualification processes, and maintain ongoing supplier quality assurance to ensure consistency and regulatory compliance.
- Report on quality metrics and key performance indicators (KPIs), highlighting trends and areas for improvement to senior management to support strategic decision-making.
- Stay informed about new and evolving pharmaceutical quality regulations, standards, and industry best practices, recommending and implementing improvements within the quality system.
- Lead continuous improvement initiatives aimed at increasing efficiency, effectiveness, and compliance within the quality control function.
Required Qualifications
- Proven experience in quality control management within the pharmaceutical industry.
- Strong knowledge of GMP, ISO 9001 standards, and pharmaceutical regulatory requirements.
- Demonstrated ability to develop and maintain SOPs and quality documentation.
- Experience in laboratory instrument calibration, validation, and maintenance.
- Skilled in root cause analysis, CAPA implementation, and quality deviation investigations.
- Experience managing audits and maintaining audit readiness.
- Strong leadership and team management skills with experience mentoring staff.
- Excellent communication and collaboration skills to work cross-functionally with various departments.
Preferred Qualifications and Benefits
- Advanced degree or certification in pharmaceutical sciences, chemistry, or a related field is advantageous.
- Experience with supplier quality management and vendor qualification.
- Proven track record of driving continuous improvement initiatives.
- Opportunity to work in a dynamic environment with a focus on professional development and industry best practices.
This role offers a challenging and rewarding opportunity for a quality control professional to contribute significantly to pharmaceutical quality assurance and compliance.