Qualified Person

☞ PCI Pharma Services

View: 110

Update day: 11-06-2024

Location: Tredegar Wales

Category: Pharmaceutical / Chemical / Biotech

Industry: Pharmaceutical

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Job content

To organise and provide QP certification for pharmaceutical products (commercial and investigational medicinal products), primarily those manufactured and assembled at PCI Pharmaceutical Services Limited, 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, on-budget and GMP-compliant delivery of completed projects for internal and external clients in accordance with service level agreements. Member of the Quality Management team.

  • 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

Qualifications
  • A minimum of a first degree in Pharmacy, Chemistry or a Life Science or significant experience (e.g.>10 years) in a regulated pharmaceutical function.
  • Eligible to act as a Qualified Person under Directive 75/319/EC (2001/83/EC).
  • A minimum of 5 years’ experience in a pharmaceutical Quality environment, with previous experience as a certifying QP preferable.
Experience
  • Operational experience within a Pharmaceutical manufacturing or laboratory setting is desirable.
  • Proficient in project management tools, with a proven ability to operate in an international company within a pre-defined timeframe.
  • Excellent communication skills both verbal and written are required in this role and people management skills would be beneficial.
  • Proven track record in the management and hands on hosting of Regulatory Inspections by international regulatory bodies
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Deadline: 26-07-2024

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