QA Associate Auditor - GMP

CORE RESPONSIBILITIES

Job Purpose

The QA Associate is a member of a team within Development Quality and is involved in supporting the GMP Quality Assurance.

Key Result Areas and Primary Activities

• Completes review of data, information, procedures, facilities, equipment and systems (inc computer systems) to
• ensure compliance to SOPs, GMPs and applicable regulations.
• Review and approve production and analytical documentation accompanying the release of drug substance, drug
• product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory
• requirements, including supporting QP certification.
• Actively communicate and collaborate with functional areas to develop a strong working relationship and
• understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise
• during audit and review.
• Support product recalls and stock recoveries as appropriate.
• Identify compliance gaps and make recommendations for continuous improvement
• Creates and maintains assigned SOPs.
• Perform and review complaints and deviation investigations, change controls and CAPA’s.
• May assist in the induction process for new starters.
• Generally follows standard procedures and consults with manager/supervisor on exceptions.
• Compiles data for reports and presentations - May interpret data and draw conclusions.
• Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in
• accordance with Company and regulatory requirements.
• Keep abreast of cGMP requirements as described in applicable worldwide regulations.
• Additional activities may be assigned by the manager/supervisor

QUALIFICATIONS

- Life science degree (MSc / BSc)

- Knowledge of GMP

- Pharmaceutical industry experience

DURATION

1 year rolling contract

SALARY

Attractive pay rate (hourly)

LOCATION

Hertfordshire / Cambridge / London

ABOUT PLANET PHARMA

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com