Brexit QA Officer - Maidenhead
Jenni Woolley at CK Group is recruiting for a Brexit QA Officer to join a company in the Pharmaceutical industry at their site based in Hurley near Maidenhead on a 6 month contract basis.
Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.
In the UK, they have around 2,500 colleagues across five locations, working within their commercial business, research and development (R&D), manufacturing, packaging and distribution operations. This position will be working out of their site in Hurley near Maidenhead.Located in the countryside close to Maidenhead the Hurley site is home to around 140 employees. Hurley is an office-based site with global and regional teams representing vaccines research & development and customer services, marketing, quality operations, regulatory affairs, medical information and safety.
Reporting to a QA Manager the Brexit QA Officer will provide day-to-day assistance for commercial QA activities associated with the effective running of the site QMS to support batch disposition activities with relation to the companies BREXIT preparations. The QA officer will ensure assigned tasks are performed in a timely manner to meet internal standards and all associated international GMP/GDP requirements.
Additionally the QA Officer will:
- Provide maintenance of quality systems primarily the creation of QP declarations and associated electronic system changes to support BREXIT preparations.
- Supporting change management activities relating to BREXIT and site compliance activities.
- Complete scheduled records and quality system tasks in a timely manner and in compliance with internal standards and EU GMP.
- Support inspection readiness for BOH inspections and external vendor audits in relation to BREXIT changes.
- Collaborate with internal and external stakeholders to resolve quality issues and ensure compliance to EU GMP standards.
- To compile & review Product quality review sets for completeness & compliance to EU GMP, Hospira internal requirements and regulatory dossier submissions.
- Project execution and support as required.
To be a successful Brexit QA Officer your should have the following skills, knowledge and experience:
- Bachelor's degree in a related scientific discipline with relevant experience (Preferably Biology/Chemistry/Pharmacy/Life Sciences).
- Basic experience in pharmaceutical manufacturing, distribution and control measures.
- Experience in Quality administered systems.
- Experience in preparing or supporting QP declarations.
- Experience in raising and management of change controls.
- Ability to apply technical knowledge and understanding to making appropriate and timely risk based decisions.
- Quality and process orientation and mindset.
- Ability to accept responsibility and be pro-active within defined limits.
- Excellent system skills - Word and Excel essential, experience with electronic documentation control systems advantageous.
- Enthusiastic, positive individual driven to meet targets and standards.
- High level of self- integrity and ethical conduct.
- Biotechnology/Biologics/Sterile injectable manufacture.
- Manufacture of novel dosage forms.
- Secondary/outsourced packaging activities.
- Global manufacture and supply chains.
- New product launches & commercial supply chain.
For more information or to apply for this position, please contact Jenni Woolley on 01438 768 710 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA44244 in all correspondence.