Audit Specialist – Gmp / Gdp – 6 Month Fixed Term Contract

I am currently recruiting for a unique Pharmaceutical organisation with an innovative business model who are looking to appoint an Audit Specialist. The organisation, on the cusp of exciting changes, are looking to build up their well-established QA team with individuals with a strong GMP and GDP background.

The company are able to offer a fantastic working environment alongside opportunity for progression, training and development.

The organisation are seeking to appoint an Audit Specialist to lead GDP. GMP audit preparation activities to support an upcoming inspection. This role is offered on a 6 month fixed term contract basis, however, given company growth, there could be opportunity for a longer term position.

Key Responsibilities:

Review and assessment of QMS documentation and records e.g. Deviations, CAPAs, Change Controls, Adverse events etc.
Management of functional designees to implement a feedback/ improvement process so that pre and post audit non-conformances are addressed in a timely manner.
Review of evidence to support the closure of actions
Effective and timely escalation of identified and critical risks to Head of Quality
Monitoring, tracking and follow-up with action owners to ensure the completion of actions
Routine reporting of progress to agreed milestones

To apply you must have:

A lifescience or equivalent degree
GDP and/ or GMP knowledge
Strong data manipulation skills
Ability to prioritise and multitask
Strong understanding of PQS (QMS) and compliance
Prior experience in leading audit preparation teams
Experience in the design and implementation of PQS (QMS)
Keen attention to detail
This client is able to provide not only a unique opportunity but also support, mentoring and training for the right candidate.

They are looking to pay between £42,000 – £48,000 + Benefits for the right candidate and can offer the opportunity to work within a successful team and to progress within the organisation.

For further information, please apply with an updated CV.