2 weeks ago

Qualified Person - QP

Merthyr Tydfill Competitive Contract

Position: Qualified Person - QP

Tenure: Permanent (5 days per week), and Contract (ongoing, 2/3 days per week)

Location: 

Permanent; on site Nr. Merthyr Tydfill.

Contractor; ideally on site, but can be remote.


Purpose:

To organise and provide QP certification for pharmaceutical products (commercial and investigational medicinal products), primarily those manufactured and assembled at the firm, but may take responsibility for products manufactured elsewhere (i.e. third country imports on occasion).

 

Responsible for QP certification of commercial and investigational medicinal products ensuring on-time, onbudget and GMP-compliant delivery of completed projects for internal and external clients in accordance with service level agreements.  Member of the Quality Management team.



Responsibilities:

  • Act as a named operational Qualified Person under the site manufacturing authorisations, and organise the certification of commercial and investigational medicinal pharmaceutical product. To maintain a register of all products certified.
  • To maintain client contact to ensure all information and documents are available to allow release to occur.
  • Devise, review, implement and manage systems within the group, including communication and information management, to achieve continuous process improvement.
  • To liaise with Business Development in the preparation of proposals requiring QP input. 
  • To liaise with customer services to ensure invoices are raised promptly.
  • Assist the Director of Quality to maintain the audit schedule for pharmaceutical products from outside the EU.
  • To liaise with key clients when necessary and, as appropriate host client audits to ensure continued successful business relationships.
  • To support the Director of Quality in interactions with UK and International regulatory bodies, taking an active part in hosting inspections.
  • To ensure GMP compliance across the firm by:

       o         Making regular visits to operational departments and offering advice and guidance with respect to regulatory expectations and recognised best practice.

o    Supporting Line QA staff in their inspection and checking duties as required.

o    Providing training to staff to increase understanding of the regulatory GMP requirements and implementation of best practices.

o    Promoting compliance across the site by adherence to, Quality Policies, SOPs and training programmes.

o    Taking an active part in the self-inspection schedule.

o    To provide advice and guidance to operational groups and clients.

  • To perform external audits to facilitate the importation of Commercial or IMP materials, including Active Pharmaceutical Ingredient and finished product manufacturing and packaging sites or as defined to meet business needs.
  • To perform audits of vendors and suppliers to firm, in order to maintain compliance with the approved supplier list as required.
  • Approve Changes as per change control SOP and take an active role in the Change Control Committee when required.
  •        To take part in Deviation investigations and review of completed deviations.
  •        To provide reviews and reports as required summarising the performance of the Quality Management System in relation to Key Performance Indicators. 
  •        To attend meetings of Quality Council to present summaries of any such reports. 
  •        To keep abreast of current legislation (CPD).


Competitive package and day rates.


Keywords:

QP, Qualified Person, Pharmaceuticals, Manufacturing, Release, Certificates, Quality, Assurance, GMP, Good Manufacturing Practice

Share this job:

Apply now

Similar Jobs

2 days ago

Interim Project Manager NEC4

Cardiff Competitive Contract

2 days ago

Senior Design Engineer - Medical Devices

Crawley Competitive Permanent

3 days ago

Head of Research & Development Manager (R&D)

Crawley Competitive Permanent