Job description
The Quality Control Head will oversee and manage the QC activities of a diverse range of pharmaceutical dosage forms, including capsules, tablets, injections, and ointments, ensuring adherence to MHRA standards, GMP guidelines, and company policies. This role is critical in ensuring that all products meet the highest quality standards and are released in compliance with regulatory requirements.
Key Responsibilities
Quality Control Operations Manage all activities within the Quality Control (QC) department, including raw material, in-process, finished product, and stability testing. Ensure all QC processes and testing adhere to MHRA guidelines, GMP, and other regulatory requirements. Ensure timely completion of testing activities to support production schedules and product release.
Regulatory Compliance Maintain compliance with GMP, MHRA, USFDA, EUGMP and other applicable regulatory requirements. Prepare and participate in regulatory inspections, audits, inspections and customer visits. Ensure robust documentation of QC activities, including test records, specifications, and certificates of analysis, in compliance with GDP and data integrity standards.
Ensure the successful execution of stability studies for all product types, adhering to ICH guidelines. Implement corrective and preventive actions (CAPAs) for quality-related issues identified during audits or inspections. Team Management Lead, train, and mentor the QC team to enhance technical skills and regulatory knowledge.
Develop and implement training programs for QC personnel to ensure adherence to MHRA and GMP standards. Assign tasks, monitor performance, and ensure efficient utilization of QC resources. Laboratory Management Oversee the maintenance, calibration, and qualification of QC equipment and instruments. Review and approve validation protocols for analytical methods and instruments.
Ensure the QC lab operates in a safe, efficient, and compliant manner. Manage laboratory investigations and out-of-specification (OOS) results. Cross-Functional Collaboration Coordinate with production, quality assurance, and R&D teams to resolve quality control issues. Provide technical expertise during product development, scale-up, and technology transfer activities.
Support supply chain activities by ensuring the timely release of materials and products.
Requirements
Key Requirements Educational Qualifications Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, or a related field. Experience 15+ years of experience in Quality Control within the pharmaceutical industry. Strong knowledge of MHRA regulations, GMP, and other international guidelines Proven expertise in QC activities for capsules, tablets, injections, and ointments Prior experience in managing QC operations in an MHRA-approved facility is mandatory.
Skills and Competencies Strong leadership and team management skills. Expertise in analytical techniques, including HPLC, GC, UV, FTIR, and other lab instruments. Proficiency in handling OOS investigations, deviations, and CAPAs. Excellent understanding of documentation practices (GDP) and data integrity principles. Ability to handle regulatory inspections and customer audits confidently.
Strong analytical, problem-solving, and decision-making skills.