Quality Operations Manager

We are currently recruiting a Quality Operations Manager for our client’s API and drug product manufacturing facility in Sligo. Reporting to the Quality Director, in this role you are responsible for ensuring that all commercial products produced are manufactured in compliance with the applicable GMPs and the site Quality System.
 
Why you should apply:
·         Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
·         The role is generously compensated, and attracts a competitive base salary and highly attractive benefits package.
·         Excellent career progression opportunities.
 
What you will bedoing:
·         Coaching, leading and developing your Quality Operations team, ensuring all product unexpected events are fully investigated, root cause determined and appropriate CAPA implemented, including provision of manufacturing quality support
·         Partnering with all departments to ensure compliance with the requirements of the manufacturing process:
·         US Food and Drugs Administration, 21 Code of Federal regulations Parts 210 and 211 and Q7A.
·         European Commission, Good Manufacturing Practices for Active Pharmaceutical Ingredients, ICH Q7A.
·         European Commission, Good Manufacturing Practices, Volume 4, Medicinal Products for Human and Veterinary use.
·         that products manufactured meet requirements of end users, Regulatory Authorities and of the company.
·         Liaising with International Quality Assurance. Ensuring QA Director is kept informed of operational failures to ensure corrective/preventive action is undertaken where required.
·         Working with QA Director and Quality Management Team to ensure site meets its customer, quality, service, regulatory and financial goals.
·         Ensuring all plant personnel are fully aware of operational quality requirements.
·         Ensuring compliance review on change requests are performed on operational /manufacturing related changes.
·         Management and monitoring performance of ER and CAPA process.
·         Verification of effectiveness of corrective/preventive actions arising out of product, and process exceptions.
·         Providing quality guidance, support, and approval on all site/system validation activities
 
 
What you need to apply:
·         You will have a 3rd level degree in a relevant technical (science/engineering) discipline with 5 -7 years’ experience in the healthcare/pharmaceutical industry.
·         5 -7 years industrial experience gained in an FDA and EMEA approved pharmaceutical environment.
QP Qualification desirable, not essential.