Senior Manager, Product QA
Senior Manager, Product QA
Based in Manorhamilton Road, Sligo, we have a high containment facility where we have dedicated capabilities for potent active pharmaceutical ingredient and drug product manufacturing. We focus on innovative new technologies and with our high performing team; we develop and deliver products and processes to support AbbVie’s wider global needs.
We are always looking for talented people to join our team and, when we find them, we make it our business to treat them well. Choose AbbVie if you share our passion for improving the health and lives of patients.
We are currently sourcing a high caliber Snr Manager, Product QA to lead and coach our diverse, technical team of 6 experienced Quality and Regulatory professionals, including 3 QPs. The successful candidate will be responsible for the release of all finished products from the site across API and Drug Product, ensuring that they meet the requirements of patients, Regulatory Authorities and AbbVie.
As a key strategic site for new product introduction within our manufacturing network, the successful candidate will be integral to the effective transfer of NPIs to our site. This will include significant involvement in Pre-Authorisation Inspections from regulatory authorities including the HPRA/EMA and FDA. You will also be responsible for product performance, managing the product complaints. We will be looking for a key Quality Talent to help us to maintain the very strong compliance reputation that we have gained through multiple PAI inspections over the last number of years.
This role is considered to be a key role in developing Quality Director’s within our manufacturing network. As a result of this and our heavy involvement with NPI activity there will be opportunities to get involved in Global Projects and to grow your career within AbbVie. AbbVie has both Small and Large Molecule Manufacturing across the world in Singapore, Italy, Germany, Puerto Rico, the US and Ireland. Our strong pipeline of products means that we are continuously expanding and therefore always looking for new talent who can develop and grow with us.
- Managing the QP and Regulatory group, including batch release, product performance, new products introduction (NPI) and regulatory support.
- Ensuring that products manufactured at AbbVie Ireland NL B.V. meet requirements of end users, Regulatory Authorities and of the company.
- Ensure the batch and its manufacture complies with the provisions of the marketing authorisation.
- Ensure manufacture has been carried out in accordance with Good Manufacturing Practice.
- Ensure the principal manufacturing and testing processes have been validated; account has been taken of the actual production conditions and manufacturing records.
- Ensure any deviations or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system. Any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority.
- Ensure all the necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes.
- Ensure all necessary production and quality control documentation has been completed and endorsed by the staff authorised to do so.
- Should in addition take into account any other factors of which they are aware which are relevant to the quality of the batch.
- Should maintain their knowledge and experience up to date in the light of technical and scientific progress and changes in quality management relevant to the products they are required to certify.
- Ensure that all QPs have gained the relevant knowledge and experience to certify a batch of a product type with which they are unfamiliar, for example because a new product range has been introduced, prior to certification.
- Ensuring compliance with the requirements of during the manufacturing process:
- US Food and Drugs Administration, 21 Code of Federal regulations Parts 210 and 211 and Q7
- European Commission, Good Manufacturing Practices for Active Pharmaceutical Ingredients, ICH Q7
- European Commission, Good Manufacturing Practices, Volume 4, Medicinal Products for Human and Veterinary use
- AbbVie Quality Assurance Policies
- Responsibility for the oversight of product performance process
- Product Quality Review
- Product Track and Trend
Quality Risk Management
- Ensure compliance with Quality Risk Management processes and procedures
- Maintain QRM program on site
- Liaising with AbbVie Global Quality Assurance and Regulatory groups, FDA, HPRA and other Regulatory bodies (where applicable).
- Liaising with AbbVie Product Quality, S&T and Regulatory affairs function in relation to product filing support.
New Product Introductions (NPI)
- Ensure effective transfer of NPIs to site and its progress into commercial manufacturing.
- Coordinate with external global teams including, but not limited to S&T, Regulatory, CMC QA
- Working with QA Director, Quality Control and Quality Systems group to ensure site meets its customer, quality service, regulatory and financial goals.
- Adheres to and supports all EHS & E standards, procedures and policies
- Third level qualification in a science discipline with minimum 5 years experience in the healthcare/pharmaceutical industry
- MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
- Minimum 5 years industrial experience gained in a FDA and EMA approved pharmaceutical environment.
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