Qualified Person/QP

Proclinical are recruiting a Qualified Person/QP for a pharmaceutical organisation. This role is on a permanent basis and is located in Wrexham. The client is focused on various life-changing remedies within multiple therapeutic areas.

Responsibilities:

• Assist in developments of site processing techniques.
• Guarantee that all training is kept up to date and reported by adhering to training plan needs.
• Ensure disposition of batches are aligned with the expectations of Annex 16 and GMP.
• Offer advice concerning observations and trends particularly areas for improvement.
• Evaluate and sanction change controls, unplanned events, out of specifications and any other investigations as needed rendering to site processes.
• When required, you will perform audits both internally and externally.
• You will guarantee that evaluation of batches to assure business expectations are maintained in a timely manner.
• Uphold divisional processes in compliant state.
• Recognise and initiate improvements.
• The ideal candidate will offer Quality assistance for local projects pertaining to site operations.
• Other duties may be assigned to this role.

Skills & Requirements:

• Educated to a degree level in a pertinent scientific field such as biology, biochemistry, chemistry, pharmacy, etc.
• Qualified Person certification.
• Fluency in the English language.
• Know-how connected to the manufacture of sterile biological drug products.
• At least 10 years of experience within a pharmaceutical organisation in a sterile manufacturing setting of which at least 5+ years are in quality assurance.
• An organised individual who is objective focused.
• Able to think laterally.
• Communication skills both verbally and in writing.
• Deliberation and influential abilities.
• Ability to prioritise workload while balancing goals.
• A self-motivated individual who can recognise crucial matters within a multifaceted setting and off resolutions to them.

If you are having difficulty in applying or if you have any questions, please contact Josh Godden on +44 203 854 0101.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-JG1

#QualityAssurance