Qualified Person - #2062456

Qualified Person – North West England – Competitive Package

BioTalent are currently representing a growing pharmaceutical manufacturer based in the North West in their search for an experienced Qualified Person.

You will be integral to the Quality department supporting on the week to week release activities alongside other major QA projects for the site. This position requires individuals to have prior experience working on a license and preferably with terminally sterilised products.

Key requirements –

• Review and evaluate batch records and authorise batch disposition.
• Manage the site QMS, monitor compliance with GMP and drive quality improvements.
• To review and approve deviations and laboratory investigations in compliance with GMP.
• To investigate and respond to complaints.
• Highly collaborative, regular interaction with senior management, Regulatory groups, QPPV, Supply chain, site-based QA, distributors, testing labs, warehouses, sales departments, customers and regulators.
• Ability to work independently with limited supervision, self-driven, responsive and results orientated.

Duties:

• The successful candidate will be qualified to degree level (as a minimum) in a relevant scientific discipline.
• The candidate must be eligible to act as a Qualified Person for medicinal products (as defined in EU Directive 2001/83/EC) and have been named on a UK MIA.
• Robust technical knowledge of EU GMP, regulations and guidelines. Experienced in the operation of an EU regulatory approved QMS.
• At least 5 years’ experience in a GMP QA role within the pharmaceutical industry and experience of managing quality systems.
• Ability to work independently with limited supervision, self-driven, responsive and results orientated.

This is an excellent opportunity for an individual who is looking to work in a fast paced, dynamic environment supported by a wider QA team.

Shortlisting for this role has begun with a view to holding first stage interviews over the next couple of weeks. For further information please contact Sarah Pawar on 0203 9115 888 or email a copy of your CV to [email protected]