Quality Specialist

PE Global International; City Of London; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A leading recruitment agency is seeking a Quality Specialist for a hybrid role in London. This is an initial 6-month contract requiring experience in the pharmaceutical industry and knowledge of GMP regulations. Main responsibilities include reviewing clinical batch records and conducting audits. Strong communication skills and attention to detail are essential for this role.

Qualifications

• Experience in the pharmaceutical or chemical industry or a government drug-regulatory agency.
• Existing experience in a QA or similar role in a GMP environment.
• Confidence to work with minimal supervision.

Responsibilities

• Final review of clinical batch records for compliance with GMP.
• Conduct routine audits to ensure compliance with SOPs and GMPs.
• Review and approve documentation for API and clinical supply lots.

Skills

Knowledge of cGMP regulations

Effective communication skills

Attention to detail

Job description

Overview

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.

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.
• Conduct routine audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure compliance with SOPs, 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.
• Communicate and resolve audit comments with client areas.
• Issue reports summarizing deficiencies and work with areas to execute remedial action.
• Notify appropriate management of inspection results.

Education/Experience

• Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with 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.

How to Apply

Interested candidates should submit an updated CV. Please click the link below to apply, alternatively send an up to date CV to (url removed).

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

Although it is not possible for us to respond to all applications, we at PE Global will do our utmost to give you feedback on your application. You have sent your CV to us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your CV is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.