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Details

QA Specialist/Responsible Person


Reference:SMC35769 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

We’re currently recruiting for an exciting opportunity with an award winning pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Maintains the Wholesale Distribution Authorisation, ensuring compliance with the general conditions detailed, in line with European and local regulations.
• To ensure compliance with the requirements of Good Distribution Practice (EU GDP).
• To ensure that all aspects of the quality system are implemented and maintained
• To ensure initial and continuous training programs are implemented and maintained.
• To have oversight of approval for return to saleable stock any medicinal products returned by a customer.
• Coordinates and performs recall operations for medicinal products.
• To be involved in any decision to quarantine or depose of returned, rejected, recalled or falsified medicinal products.
• To approve new customers and suppliers and periodic review of existing customers and suppliers.
• Management of customer complaints, ensuring they are dealt with effectively
• To escalate any complaints, reported defects, reported falsified medicinal product
• The approval of sub-contracted activities which may impact on GDP.
• To notify HPRA of any change of RP by way of variation to the License.
• The role profile of the Deputy Responsible Person is to act in accordance with the above requirements in the absence of the RP, ensuring to keep appropriate records of any delegated duties

Education & Experience

• Bachelors Degree in a scientific/technical discipline required
• Experience in a quality or compliance role within the pharmaceutical industry, most specifically in relation to GMP and GDP.
• Formal certified GDP Training on Good Distribution Practice of Medicinal Products for Human Use
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.

Desireable
• Experience in auditing of external suppliers, contractors and vendors.
• Previous experience working as a Responsible Person


If you would like further Information you can contact the recruiter directly:

Sean McCarthy | Tel: +353 (0) 87 798 8480