QA Compliance Officer - Production
About Chanelle Pharma:
Chanelle Pharma is Ireland’s largest indigenous generic pharmaceutical manufacturer of both medical and veterinary products.
Serving customers in 96 countries worldwide, Chanelle Pharma is a partner of choice in the development and manufacturing of pharmaceutical products to the world’s leading human generic and animal health multinationals and distributors. We are passionate about understanding and addressing the challenges facing our medical and veterinary customers and bringing them innovative and effective products and solutions.
The Opportunity:
This is an opportunity to proactively lead and deliver the day-to-day Quality Assurance function across Chanelle Pharma’s assigned Production areas (Solid Dose, Liquids, and Packaging). The role will be responsible to deliver on all aspects related to quality compliance and execute tasks such as the creation and execution of quality documents to include change control, deviations, CAPA, FMEA whilst ensuring compliance to the Quality Management System.
KEY RESPONSIBILITIES:
- Ensure all quality reports are written and approved within the required timeframe by the department
- Create, Lead & Review Process investigations and Risk Assessment Documents to ensure any such investigations are documented appropriately with relevant corrective actions, if necessary.
- Raise, investigate, and review compliance documents e.g., Change Controls, Deviations, SCARS, Reject Notices, and CAPAs.
- Conduct routine Quality Audits of the department to ensure compliance and be proactive in resolving issues which may arise.
- Provide and update existing Quality Procedures such as Standard Operating Procedures (SOP’s) in line with GMP regulations
- Contribute to the overall improvement of the company from a Quality/GMP perspective with an emphasis on continuous improvement of the quality system.
- Support or where necessary lead Quality based projects within the department 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 participate in Change Control meetings and the monthly ‘Quality Management & Review’ meeting
- Any other duties assigned by the responsible Production Manager.
COMPETENCIES:
- Excellent Communication and Interpersonal skills
- Analytical, Methodical, and structured approach to organising their work
- Process Improvement Mindset essential
- Ability to manage multiple critical priorities
- Exceptional Team Playing skills with the ability to manage multiple stakeholders
- Displays flexibility and shows willingness to learn and do that little bit extra
QUALIFICATIONS:
- Bachelor’s degree in Quality or Science based discipline
- Lean/Six Sigma, Statistical knowledge is preferred and advantageous in the role
- Minimum of 4-5 years’ experience in a GMP manufacturing environment with working knowledge of EU GMP and US FDA Guidelines essential
- Experience working in pharmaceutical preferred however medical device industry experience will also be considered
- Excellent Report Writing and IT Skills
- Demonstrated hands on experience of delivering a best-in-class QA function in a similar role
PHYSICAL DEMANDS:
Health & Safety requirements (eg. Manual Handling Training)
- VDU
- Manual Handling
WORK ENVIRONMENT:
- Office
- Production
- Warehousing
