Head of Quality & QP

Our client operates in the Pharma industry and they would like to engage a Head of Quality & QP within their company. You will be reporting directly into the Group Head of Quality

The Role

• You will plan, manage and coordinate all activities of the Quality Control Laboratory, Quality Assurance Department and also any related Quality Operations
• You will ensure efficiency both in time and material resources whilst ensuring compliance with cGMP, company procedures, EHS regulations as well as Pharmacopeial standards
• Ensure adequate/appropriate resources to implement and maintain the quality management system within the Quality Unit and strives continually to improve its effectiveness.
• Manages and monitors the development and implementation of then necessary and adequate Quality Systems and its respective Improvement Program
• To manage the system of approve, conditionally approve or reject, as deemed fit, starting materials, packaging materials, intermediate, bulk and finished products, following all necessary testing is carried out and the associated records evaluated
• To ensure the approval and monitoring of suppliers and contractors of GMP related outsourced activities
• Assures that all laboratory documentation is complete and accurate and that new employees are properly trained
• Ensures that out of specification results/parameters, deviations and non-conformances are reported and investigated in a timely manner, following with the implementation of the appropriate corrective and/or preventive actions to assure that all released product on the market has the appropriate quality attributes
• To approve specifications, sampling instructions, test methods and other Quality Control procedures
• Ensure that the necessary Reference and Retain samples are maintained and controlled adequately
• Manages and approves Contract Laboratories and oversees the approval of contract analysts
• Ensure the qualification and maintenance of the Quality Control department, premises and equipment
• Ensures that the appropriate validations and qualifications for facility and equipment are performed and approved accordingly
• Ensures that the appropriate analytical method validations are performed and followed accordingly
• Ensures that instrumentation is maintained in good working condition and is calibrated as required
• Manages and approves Validation and Master documents against company procedures and relevant regulatory laws and guidelines as required
• Perform as necessary any QP duties as per 2001/83/EC
• Reviews and prepares annual budget for assigned areas of responsibility in the Quality Unit
• To participate in management reviews of process performance, product quality and of the quality management system and advocate continual improvement
• To ensure compliance with established procedures relevant to the EHS management system in line with the organisation’s policies, procedures, international standards and local and EU regulations in the daily operation of the Department
• To participate actively in case of an emergency situation requiring the activation of Business Continuity Plans.
• To keep the principles of Business Continuity at the forefront in the management of the department

• Bachelor’s Degree in Chemistry, Pharmaceutical Science or related field from an accredited college or university
• A minimum of 5 years of progressive management experience; preferably in food, cosmetics or in in the pharmaceutical industry, or an equivalent combination of training and experience
• Preferably already registered as a Qualified Person with the Pharmacy Council
• A Post Graduate Degree in a science related field is considered an asset