- Maintains the Wholesale Distribution Authorisation, ensuring compliance with the general conditions detailed, in line with European and local regulations.
- Ensure compliance with the requirements of Good Distribution Practice (EU GDP).
- Confirm that all aspects of the quality system are implemented and maintained
- Ensure initial and continuous training programs are implemented and maintained.
- 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 Licence.
- To manage self-inspections of the facility, ensuring that they are performed at regular intervals following a prearranged programme and necessary corrective actions are put in place
- Bachelor’s Degree in a scientific/technical discipline required
- A minimum of 3-5 years’ 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. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. Strong Knowledge of regulatory requirements pertaining to GDP.
- Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, HPRA, EMEA and other authorities.
- Experience in auditing of external suppliers, contractors and vendors.
- Previous experience working as a Responsible Person
For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email firstname.lastname@example.org