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Job Ref.: 1711

Job Title: Qualified Person (QP) – Pharmaceuticals – Dublin West based – February 2019 – Immediate vacancy

Posted Date: 16/02/2019

Sector: Qualified Person (QP)

Location: Ireland, Dublin West

Job Type: Permanent full-time

Job description:

Qualified Person (QP) – Pharmaceuticals – Dublin West based – February 2019 – Immediate vacancy

Our client is a pharmaceutical wholesaler established in West Dublin since 2005. They are part of a large international group which is a key player in trading finished pharmaceuticals all over Europe and worldwide for the past 60 years. They supply finished medicines to wholesalers, pharmaceutical importers, clinical trials comparator, hospitals and governments. They also offer third party warehousing and distribution services.

They are now looking to recruit a Qualified Person to run their current GDP QMS and lead the company through acquiring and running a Manufacturer Import Authorisation.

The applicant must hold a pharmacist degree with good knowledge and experience in GMDP procedures.

The role is is permanent but they are also flexible to someone who wants to work a four day week.

Job Duties:

  • Insure company’s compliance with all GMDP requirements

  • Deviation/Change Control/ Risk assessment/Regulatory Compliance/CAPA

  • Review, maintenance and development of the company’s Quality Management System

  • Liaising with local and external affiliates to ensure regulatory compliance is maintained

  • Initiating and managing regulatory compliance remediation activities to ensure compliance with GMDP practices

  • Assures completeness in terms of root cause analysis, action taken, and preventative measures (CAPA).

  • Authors, tracks, and ensures timely closure of commitments (Regulatory Agency, investigation, audit, and other).

  • Performs installation qualification, operational qualification, performance qualification (IQ, OQ, PQ) on site’s equipment.

  • Authors and ensures timely completion of Change Controls, Action Requests, and overall CAPAs

  • Provide training and insure training is maintained for all relevant staff.

  • Validation and auditing of Suppliers and Customers.

  • Insure internal audit, self-inspection, management reports

  • Auditing and validation of transporters and third party contractors

  • Responsible for the liaison with regulatory authorities.

  • Provide batch release for Non-EU medicines to be released in the EU.

An excellent salary plus strong benefits package will be offered to the successful candidate.

For further information, please call Paul Flanagan at +353 1 805 5522 or email your c/v in the strictest confidence to paul@pharmasolutions.ie

 

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