KEY RESPONSIBILITIES:

• Responsible for Quality Complaints Programme
• Ensure timely acknowledgement of Customer Complaints and Appropriate logging within the QMS
• Ensure reports are written and approved within the required timeframe
• Forwarding any associated Product Quality Defects to the respective Pharmacovigilance department
• Liaising with the HPRA for product quality defects reporting
• Review / lead Process investigations / Risk Assessment Documents and ensure any such investigations are documented appropriately with relevant corrective actions, if necessary.
• Support with Review and approval of Compliance documents e.g. Deviations, SCARS and CAPAs.
• Conduct Routine Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise.
• Conduct annual GMP training to respective GMP Areas as and when scheduled.
• Quality review and approval of MWO’s & PWO’s.
• Provision/Updating of existing Quality Procedures
• Contributing to the overall improvement of the company from a Quality/GMP perspective with an emphasis on continuous improvement of the quality system.
• Preparing product quality review reports

• To carry out GMP walks as required.

• Support during Quarantine and Recall activities
• Support or where necessary lead Quality based projects including working as part of a multidisciplinary team as required.
• Participation in the self-inspections, internal and regulatory audits and ensuring necessary corrective actions are put in place.
• Support and participation in the monthly Quality Management & Review.

• Any other duties assigned by Quality Management

COMPETENCIES & QUALIFICATIONS:

• Bachelor’s degree in a science-based discipline with a minimum of 2-4 years’ experience in a pharmaceutical manufacturing environment with working knowledge of EU GMP and US FDA Guidelines
• Displays key behaviours such as:

• Takes direction and asks questions
• Relates well to the rest of the team
• Develops own technical skills
• Takes a methodical, systematic and structured approach to organising work
• Ability to prioritise decision making differentiating between urgent and non-urgent
• Escalates issues appropriately
• Offers to help others when needed and creates a sense of harmony in the team
• Displays flexibility and shows willingness to learn and do that little bit extra
• Excellent Report Writing Skills