Description
Pharmaceutical company based in Co. Wiclow is seeking a QP to join their Qualiy Team.For the Manufacturing license, act as a Qualified Person in accordance with EU Directive /EC. The brief requires a thorough knowledge of Good Manufacturing Practice, current FDA & EMA regulations for solid oral dosage pharmaceuticals for human use and a good working knowledge of manufacturing processes, packaging processes and validation activities used in the pharmaceutical industry. Good organisational, supervisory, technical writing and investigation skills are required.
Key Areas of Responsibility:
- Cooperate with Production to ensure continuous improvement
- Provide details on corrective actions required for batch deviations
- Assist in the implementation of Quality Systems within production to ensure compliance with GMP
- Provide regular feedback to other QP's on main issues for relevant production plant
- To act as Quality representative on major projects as required.
- Communication / liaison with other departments.
- Participate fully in any cross-functional training initiatives.
- Participate in the vendor audit program.
- Participate in the self-inspection programme.
- To assist in audit preparation for regulatory and customer audits and to act as a member of the audit team as required.
- Maintenance of the Quality Systems within The company.
- Other duties as required and as directed by the Senior Director, Quality or other officer appointed by the Board of Directors.
The successful candidate will have:
- Have a minimum of five years experience in the Pharmaceutical Industry in a QA role.
- QP experience in solid oral dosage manufacture and/or packaging is preferable
- Good organizational, investigational & technical writing skills are required
- Be a self starter who is motivated & innovative
- Possesses suitable educational background that meets the requirements of Article 49 of Directive /EC.
If you are interested in hearing more information on the role and the company please apply below with an up to date CV.