A well-known international pharmaceutical company with sites around the globe is looking to hire a QA Officer. The company specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology.
- Providing 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.
- Ensuring assigned tasks are performed in a timely manner to meet internal standards and all associated international GMP/GDP requirements.
- Providing 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.
- Completing 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.
- Collaborating 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.
Skills and Requirements:
- 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. Previous use of Trackwise® QMS beneficial.
- 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.
- Able to demonstrate good planning and organisation skills.
- Attention to detail and accuracy - able to follow verbal and written instruction (SOP's).
- Quality and process orientation and mindset.
- Possession of good verbal and written communication skills.
- 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.
- Prior Experience Preferred:
- 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
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Steven Fuller at +44 203 854 2630 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.