Quality Specialist

Desired Skills: cGMP,SOP,batch

PE Global is currently recruiting for a Quality Specialist for a leading multi-national Pharma client based in Moorgate, London.

This is an initial 6 months contract position offering hybrid work. 37.5 hours per week.

Pay Rate is from £17.79ph up to £30.25ph PAYE. Depending on experience.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***

Duties of the role/Responsibilities

• As a Quality Specialist, you will be responsible for the final review of clinical batch records to ensure compliance with GMP and conformance with regulatory filings.
• The compilation and approval of this data pack and presentation to the QP for final release is the core function of the role.
• Conducts routine audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure the compliance with SOPs and GMPs and worldwide regulations.
• Review and approve production and analytical documentation accompanying the release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements.
• Communicates and resolves audit comments with client areas.
• Issue reports summarizing deficiencies and work with areas to execute remedial action.
• Notify appropriate management of inspection result.

Education/Experience

• Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations.
• Existing experience in a QA or similar role in a GMP environment
• Effective communications (oral/written) and interpersonal skills are necessary.
• Confidence to work with minimal supervision, and a keen eye for detail.

Interested candidates should submit an updated CV.

Please click the link below to apply, alternatively send an up to date CV to anett@peglobal.co.uk

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***