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QUALIFIED PERSON, ASSOCIATE DIRECTOR
Company:RFT GROUP |
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Job Reference Number |
14572055 |
Client ID: |
RI/ |
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Posted On: |
Feb 22 2012 |
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Location: |
DUBLIN |
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Job Type: |
Permanent |
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Salary: |
ASSOCIATE DIRECTOR |
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Benefits: |
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Our client is a rapid expanding major multinational pharmaceutical company
The individual appointed to this permanent role will manage QP and RP group Operations team, reporting directly to the Int. Director of QA (EU & ROW). This group is responsible for Qualified Person (QP) and Responsible Person (RP) duties to support, contract manufacturing operations, supply chain operations and supplier quality functions performed on behalf of the company. This individual will be responsible for the timely completion of goals and objectives. This position will have direct reports from within the QP and RP group in Dublin & Sweden.
The position may require up to 35% travel.
Job Spec :
This position is responsible for the management of the European QP/RP operation to all applicable standards for GMP and GDP. This individual will receive assignments in the form of goals and tasks.
The individual may be responsible for, but is not limited to:
• Performing batch disposition and Qualified Person (QP) release as required.
• Management of EU Manufacturing & Distribution Authorizations (Licenses) and Qualified Person functions.
• Manage quality metrics performance for the reporting group.
• Perform duties as a designated Responsible Person (RP) in accordance with 2001/83/EC (Amended by 2004/27/EC).
• Management of Sweden QP duties including associated personnel/contractors and Dublin RP deputies as applicable.
• Management and maintenance of all relevant Technical Quality Agreements (TQAs).
• Oversight of European Product Complaints and Recall.
• Execution of European site external and internal audits.
• Execution of process improvement projects.
• Serving as point of contact for regulatory agency inspections.
• Leading product related investigations and nonconformance reviews.
• Supporting the annual Product Quality Reviews.
• Reviewing and approval of batch records, specifications, deviations, change controls
• Primary contact for MPA regarding recall, inspection and MA.
• QA review of regulatory submission as required (CMC section etc).
Person Spec:
Essential:
• European Qualified Person (QP) for Sweden.
• European Responsible Person (RP) for Ireland.
• Experience working as a QP or deputy QP and experience working in the QA, QC functions.
• Bachelor’s degree in pharmacy, chemistry, biology or a related discipline.
• Significant experience working in biopharmaceutical industry.
• Thorough understanding of quality systems, cGMPs, GDPs.
• Experience with Aseptic / Sterile Processing.
• Interpersonal skills and professional skills to interact with contractors.
• Must be able to prioritize and multitask in an environment with changing priorities.
• Must be able to travel up to 35%.
Desired:
• Meets qualifications to be European Qualified Person (QP) for Ireland.
• Experience working with multiple sites/ locations.
• Experience interfacing with regulatory bodies or working on regulatory submissions.
• Advanced Degree.
Cv to gerry@rftgroup.ie 01 2302400 www.rftgroup.ie
