Job Description

Maintain provision of quality control services across the business to maintain satisfactory internal and external customer service.
Ensure the QC department’s adherence to relevant company procedures and requirements of cGMP.

• Routine review and disposition of starting material and finished product batches using a risk based approach.
• Monitor internal calibration activities and management of external calibration and qualification activities through liaison with 3rd parties and departments within the company.
• Develop and manage technical agreements held with 3rd party service providers including external testing laboratories.
• Support and critically review method and equipment validation activities.
• Prepare starting material specifications, standard test methods and operating procedures in accordance with company procedures and good documentation practices.
• Conduct quality incident investigations, including OOS investigations, and lead detailed root cause analysis investigations using relevant tools and techniques.
• Manage timely completion of Corrective and Preventive actions as part of the continuous improvement process within the department and beyond.
• Supervise, coach and mentor team members in line with the Groups policies
• Support company 1st, 2nd and 3rd party audit activities.
• Lead key project work with significant QC elements and provide support to routine cross department activities.
• Ensure department compliance to cGMP through continual review and self-auditing against the relevant guidelines.
• Any other reasonable duties as identified by management.

Required Knowledge, Skills, and Abilities

Sound written and verbal communication skills. Decisive thinker able to work within agreed timescales. Degree Qualification in a Science Discipline. Experience of all key analytical techniques and analytical method development. Excellent computer skills, experience with Microsoft office essential. Excellent planning and organizational skills to ensure workload prioritization and schedule adherence. A strong personal presence with excellent leadership, interpersonal and relationship building skills. Knowledge of BRC, MHRA. Knowledge and understanding of interpretation of cGMPs and regulatory requirements, experience of regulatory inspections and customer audits. Auditing skills and / or lead auditor trained. Experience of QC/QA related activities within a food or pharmaceutical manufacturing business.