- Experience Level
- Experienced (non-manager)
We are currently looking for a talented and experienced QA Officer to work with a QA Manager to 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.
* 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
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
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.