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Qualified Person
Eingestellt von Quanta Consultancy Services
Projektbeschreibung
ROLE - QUALIFIED PERSON
TYPE - 6 MONTH CONTRACT
LOCATION - CO. CORK IRELAND
KEY RESPONSIBILITIES:
The above position will be working with the Quality department within the Sterile team, carry the following responsibilities:
- Execute the responsibilities of a Qualified Person as per Annex 16
- Perform the QP Release of both commercial and clinical Finished Products manufactured on site,
- Lead and participate as a team member in Quality Continuous Improvement projects
- Provide QP Guidance to the site
- Participate in Investigations/Fact Finding Meetings as required and drive CAPA effectiveness.
- Ensure compliance with cGMP and other business compliance regulations and Procedures.
- Participation in Corporate/Regulatory Inspections on site when required.
- Training and development of area personnel
- Delivery of area performance to meet or exceed performance or quality goals.
- Active participation at the Deviation Review Board, Stability Review Board, Site Quality Council and other relevant forums pertinent to product quality review.
- Lead, promote and participate in the implementation and maintenance of the SHE programmes where relevant.
KEY REQUIREMENTS:
- Third Level science qualification, and a QP Qualification
- Experience working in a Pharmaceutical Environment, preferably in a Sterile Manufacturing Facility.
- Experience of preparing for and participating in regulatory audits in particular IMB/FDA.
TYPE - 6 MONTH CONTRACT
LOCATION - CO. CORK IRELAND
KEY RESPONSIBILITIES:
The above position will be working with the Quality department within the Sterile team, carry the following responsibilities:
- Execute the responsibilities of a Qualified Person as per Annex 16
- Perform the QP Release of both commercial and clinical Finished Products manufactured on site,
- Lead and participate as a team member in Quality Continuous Improvement projects
- Provide QP Guidance to the site
- Participate in Investigations/Fact Finding Meetings as required and drive CAPA effectiveness.
- Ensure compliance with cGMP and other business compliance regulations and Procedures.
- Participation in Corporate/Regulatory Inspections on site when required.
- Training and development of area personnel
- Delivery of area performance to meet or exceed performance or quality goals.
- Active participation at the Deviation Review Board, Stability Review Board, Site Quality Council and other relevant forums pertinent to product quality review.
- Lead, promote and participate in the implementation and maintenance of the SHE programmes where relevant.
KEY REQUIREMENTS:
- Third Level science qualification, and a QP Qualification
- Experience working in a Pharmaceutical Environment, preferably in a Sterile Manufacturing Facility.
- Experience of preparing for and participating in regulatory audits in particular IMB/FDA.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges