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QA Specialist/Responsible Person

  • Job reference: 925001
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 18/04/2019

OrionGroup are looking for a QA Specialist / Responsible Person on behalf of our multinational pharmaceutical client based in the Cork area on an initial 12 month contract.

Position Summary:

This position is responsible for carrying out tasks and projects related to Good Distribution Practices as required by GDP regulations.
Provides effective and efficient quality assurance support to Quality Manager including supporting the implementation and maintenance of the QMS with specific focus on distribution related activities.
As Responsible Person, in line with EU and local regulations, maintain a high level of QMS and local regulatory knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential adversity with regards to GDP.

Main Responsibilities of the role:

* 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 Licence.
* To manage self-inspections of ensuring that they are performed at regular intervals following a prearranged programme and necessary corrective actions are put in place;
* 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

Desired Experience and Background of the successful candidate

  • 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
    * Excellent interpersonal skills
    * Ability to operate as part of a team is critical.
    * Customer focus
    * Innovative
    * Excellent communication skills both written and verbal

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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