Helsinn Pharmaceuticalst Ltd requires a QA Manager/QP for its development and commercial manufacturing site in Dublin.
Job Vacancy- QA Manager
The primary purpose of the QA Manager is to effectively manage the QA Department as to ensure all regulatory, cGMP and corporate standards are consistently maintained throughout all manner of activities associated with the manufacture and release of commercial and investigational medicinal products.
The following is a non-exhaustive list of the tasks and responsibilities associated with the role of QA Manager.
- Fulfilling the role of the Qualified Person for commercial and investigational medicinal products (IMPs) within the company in accordance with EU Directives and relevant current guidelines.
- Managing the QA systems of the site to ensure that high quality products are consistently delivered on time to customers.
- Reviewing Deviations and Laboratory Investigation Reports and following up on prescribed actions as required.
- Supporting New Product Development activities within the company with respect to GMP and quality system adherence.
- Planning, organising, directing and controlling the day to day activities and performance of relevant QA personnel.
- Ensuring QA personnel are adequately trained and developed.
- Cooperating with all Departments to ensure the achievement of the company’s strategic objectives.
- Ensuring all company personnel are trained in current GMP’s as applicable to their function.
- Assisting the company in preparing for compliance audits by customers/regulators, to include the satisfactory close out on any matters arising from same.
- Reviewing and approving all manufacturing and testing master protocols and procedures and the associated document control activities.
- Ensuring that all validation activities are executed in accordance with company, industry and regulatory standards.
- Promoting and maintaining good people management practices in the company aimed at maintaining positive employee relations and high standards of performance.
- Demonstrate effective decision making / problem resolution skills.
- Participating in cross departmental problem solving/investigation teams
The successful applicant must possess the following knowledge, skills, qualifications, attributes and experiences.
- An MSc in Pharmaceutical Science (QP Status)
- At least 10 years’ experience in the Pharma industry having served a minimum of 5 years at a Supervisory Level (or above) in a “Quality” centric capacity.
- A minimum of 4 years’ experience of Batch Release (I.E, operating as QP)
- Experience of working within a FDA regulated environment
- Previous experience of IMP release activities.
- Excellent People Management Skills
- Excellent Organisation, Report Writing, Communication and Presentation Skills.
- Sound Decision Making and Negotiation capabilities.
- Ability to interact professionally with all stakeholders (incl Top Corporate Management)
- Ability to work in a dynamic (multi priority) and changing environment
- In-depth knowledge of a wide variety of manufacturing techniques.
- Ability to troubleshoot and identify technical issues and follow up with corrective actions.
- Thorough understanding of related FDA and IMB requirements and regulations
Although not essential, the ideal candidate will also have;
- Solid/Semi Solid Dose Experience
- Time served in a Production/Formulation related role.
Helsinn is an Equal Opportunity Employer and Welcomes applications from employees who meet the above criteria. To apply, please submit updated CV with cover letter to Andrew Hayes by 18th of February through the Apply Button below.
NO AGENCY ASSISTANCE IS REQUIRED AT THIS TIME.
About the Company
Helsinn Birex Pharmaceuticals,Dublin,Ireland, manages the supply of finished drug products for the Swiss based Helsinn Group. In house capabilities include the development, manufacture and packaging of solid dosage forms and topicals. Additionally the company carries out final packaging of special dosage forms such as sterile forms and softgel which are produced by a worldwide network of CMOs.
The site was established in 1997 and now occupies an area of 9000 sq. meters including both production and pilot scale facilities for scale up commercial production and packaging. The site is EU and FDA approved for Commercial supply and holds an EU IMP Licence for the storage and packaging of Clinical Trial materials.
The Company employs 150+ people at the Dublinsite. The three main commercial products produced are Nimesulide (a non-steroidal anti-inflammatory drug or NSAID) Klean-Prep (a gastro intestinal medicine), and Palonosetron (an anti-emetic product).
Further information can be obtained by visiting www.helsinn.com