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Job Ref.: 1737

Job Title: Director of Quality/QP – Pharma Consultancy – Dublin North – Urgent - April 2019

Posted Date: 20/04/2019

Sector: Quality/QP Director

Location: Ireland, Dublin North

Job Type: Permanent full-time

Job description:

Director of Quality/QP – Pharma Consultancy – Dublin North – Urgent - April 2019

Our client, a privately-owned pharmaceutical consultancy firm wish to appoint a Director of Quality/QP to join their expanding team.

The position is permanent and will be based in North Dublin.

Key Objectives

1.To lead direct and develop our clients’ quality team. Establish plans, strategies and provide direction to team. Ensure the business complies with its client commitments, has adequate capacity/resources and delivers customer service efficiently.

2. Drive for continuous improvement, Set clear goals/targets and monitor performance of quality team including associates. Ensure training and upskilling of team is carried out to current standards.

3. Maintain Quality standards in-order to maintain/retain licences to operate. Ensure PQS is current and effective and requirements are met by quality team. Drive and support improvements to the PQS system, quality risk management and continuous improvement.

4. To deliver high quality service for all the activities under the

Manufacturers/lmporters MIA(s), including provision of quality oversight for material/product importation and completion of material/product disposition, within timelines agreed with the client companies, as appropriate.

5. To engage with new business and deliver efficient and effective services to client companies. This includes establishment of QTAs, completion of audits, if required, and completion of training on the client/third party company PQS, material/products and associated systems/controls. Ensure that the client/third party company PQS complies with the regulatory requirements prior to commencing duties as a QP.

6. To perform a range of Quality activities relating to product disposition for client companies, to include the provision of quality oversight for importation of materials/products to the EU/EEA and adherence to/improvement of the company Quality System (PQS). This shall include client liaison, batch document review/control, material/product disposition, active participation in deviation/complaint/quality defect/recall/other investigation matters along with input to/participation in change management processes.

 

 

Qualification/Years of Experience:

(short description, not a full job specification)

Minimum of an honours degree with at least ten years experience in Quality management, with operational experience within the pharmaceutical industry and at least five years working as a QP. Proven leadership and decision making skills.

 

Key Responsibilities/Tasks

(note that the training required for each key task is reflected in the accompanying training programme document)

List:

1. Achieve Quality compliance and provide Quality authorisation for our clients’ business that is conducted under the MIA(s).

Achieve and retain Quality licence(s) to operate and keep a high focus level on Quality performance at MIAS Pharma. Keep abreast of current Quality legislation, guidelines and standards. Maintain the company MIA(s) and ensure they are up-to-date. Ensure that the company PQS complies with regulatory requirements and is line with best practice standards. Complete the job-training programme for a Qualified Person (QP) within the company. Set clear goals/objectives and clarify key quality focus/improvement areas for MIAS Pharma and the Quality team. Maintain a regular documented Quality review process, that includes a review of Quality performance versus key Quality metrics/KPIs, for all key elements of the PQS including:

> Quality Technical Agreements

> Document Control, Retention and IT Systems

> Training

> Complaint Management

> Deviation Management

> CAPA Management

> Quality/PQS Reviews

> Change Management

> Licence Management and Quality Support for Regulatory Affairs

>Client Engagement/Management including quality oversight of importation and

batch disposition activities

2. Provide leadership and direction to Qualified Persons to ensure compliance of the QP activities with Eudralex Volume IV, Annex 13, Annex 16, with the relevant MA, PSF and with the conditions of the MPI MIA(s).

Adhere to the requirements of Eudralex Volume IV, Annex 13 (Investigational Medicinal Products), Annex 16 (certification by a Qualified person and batch release). Ensure compliance of batches certified for release with the requirements of Good Manufacturing (GMP) and the Marketing Authorisation (MA)/ Product Specification File (PSF). Perform batch document review/control, material/product disposition and actively participate in deviation/complaint/quality defect/stability investigation/recall and other investigation matters and input to change management processes. Provide QP Declarations, Quality Statements and other such support for regulatory affairs if/as required. Work alongside the QS Co-ordinator to ensure the completion and review of all required PQS documentation, including forms, logbooks and registers.

Expected amount of travel required: 25%

An excellent salary, depending on experience, will be offered to the successful candidate. In addition, an excellent benefits package will apply.

For further information, please call Paul Flanagan at Dublin 01 805 5522 or email your details in the strictest confidence to paul@pharmasolutions.ie asap

 

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