QP (Qualified Person) Pharmaceutical
- Reference: JLS QPP
- Location: Cardiff
- Salary: Upto £80k
- Type: Full time
- Start: ASAP
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.
Qualifications, Skills and Experience
- Technical/Quality Assurance
? Act as a named operational Qualified Person under the site manufacturing authorisations, and organise the certification of commercial and investigational medicinal pharmaceutical products. 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 Pharmaceutical Services Organisation 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 the company, 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).
? Review and improve departmental processes and eliminate waste.
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
- 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.
If you have the experience in this role and have the relevant experience please email justyn at justlifesciences dot com or visit our website justlifesciences dot com
Just Life Sciences
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