Head of QA

Scottill Healthcare is seeking an experienced and dynamic Head of Quality Assurance (QA Head) to lead the quality function at our pharmaceutical manufacturing facility. The ideal candidate will have extensive experience in sterile injectable manufacturing and a strong understanding of pharmaceutical quality systems, regulatory requirements, and compliance standards.
Key Responsibilities:
• Lead and manage the Quality Assurance department for sterile injectable manufacturing operations.
• Ensure compliance with EU GMP, WHO-GMP, applicable national regulations, and other relevant pharmaceutical quality standards.
• Oversee quality assurance activities related to the manufacturing, filling, inspection, packaging, and release of injectable products.
• Establish, implement, and maintain robust pharmaceutical quality systems in accordance with current GMP requirements.
• Review and approve batch manufacturing records, batch packing records, specifications, standard operating procedures, protocols, reports, and other GMP documentation.
• Ensure effective handling of deviations, incidents, change controls, CAPA, out-of-specification results, out-of-trend results, and product complaints.
• Oversee investigations related to manufacturing and laboratory activities and ensure timely implementation of corrective and preventive actions.
• Review and approve validation and qualification activities, including process validation, cleaning validation, sterilization validation, media fills, equipment qualification, and computerized system validation.
• Ensure compliance with aseptic processing requirements, environmental monitoring programs, personnel gowning practices, contamination control strategies, and sterile area procedures.
• Lead internal audits, vendor audits, customer audits, regulatory inspections, and follow-up activities.
• Ensure the facility remains inspection-ready and that all observations are addressed effectively and within the required timelines.
• Collaborate with Production, Quality Control, Engineering, Regulatory Affairs, Warehouse, and other departments to maintain product quality and compliance.
• Provide guidance, training, and leadership to the QA team and promote a strong culture of quality and continuous improvement.
• Monitor quality metrics and prepare periodic reports for senior management.
• Ensure that all activities related to injectable manufacturing are performed in accordance with approved procedures and regulatory expectations.
Required Work Experience:
• Extensive experience in Quality Assurance within a pharmaceutical manufacturing environment, with a primary focus on sterile injectable products.
• Hands-on experience in aseptic manufacturing, sterile filling, terminal sterilization, visual inspection, and injectable product release activities.
• Strong knowledge of injectable manufacturing processes, cleanroom operations, contamination control, environmental monitoring, and microbiological controls.
• Experience in reviewing and approving batch documentation for injectable products.
• Practical experience in deviation investigations, CAPA management, change control, risk assessment, and product quality review.
• Experience in qualification and validation activities related to sterile injectable facilities, equipment, utilities, processes, and cleaning procedures.
• Proven experience in handling regulatory inspections and customer audits for injectable manufacturing facilities.
• Strong knowledge of EU GMP, WHO-GMP, current GMP requirements, and applicable regulatory guidelines for sterile pharmaceutical products.
• Experience in managing and developing QA teams in a regulated pharmaceutical manufacturing environment.
• Candidates with experience exclusively in injectable manufacturing will be preferred.
Candidate Profile:
• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Microbiology, or a related field.
• Strong leadership, decision-making, communication, and problem-solving skills.
• Ability to work independently and manage multiple quality-related activities effectively.
• High attention to detail and a strong commitment to product quality and patient safety.
• Willingness to support regulatory inspections and business requirements as needed.

Work arrangement
No