Senior QA Officer - Pharmaceutical
United Kingdom
This is an exciting opportunity to work for a successful and expanding pharmaceutical company based in the South West area, who is seeking to recruit a Senior QA Officer to work in their Quality Department
Duties:
Prepare and review manufacturing and testing instructions for new manufacturing sites
Review and approve master documents related to product licences held within the group, including process validation protocols, BMRs, analytical specifications and methods
Ensure compliance of documentation from third party manufacturers
Liaise with and support contract manufacturing sites associated with particular products
Review quality documentation from third party manufacturers for regulatory submission
Undertake quality investigations (OOS, deviations, complaints) using appropriate tools
Qualification and Experience
Bachelor’s Degree in a science field (minimum)
Relevant experience in the pharmaceutical industry; experience in quality assurance/compliance with at least 5 years’ experience.
A sound understanding of quality compliance, manufacturing and testing principles and process validation.
Awareness of both the EU pharmaceutical regulatory system and EU GMP guidelines.
Experience in prioritizing conflicting demands
Demonstrate good interpersonal skills required to build working relationships with internal stakeholders and third party manufacturers / contractors.
Good computer skills with standard software packages (Word, Excel etc)
Excellent verbal and written communication skills with the ability to communicate in English in a clear and easy to understand manner
Ability to work across cultures/countries/sites
Dependability: team-oriented, reliable, responsible, dedicated, committed and fulfilling obligations
We can only accept applicants who are living in the UK and eligible to work without restrictions.