Our client, a pharmaceutical manufacturing and marketing company is seeking a Quality Assurance Officer to join their time in Berkshire, UK. The company's primary focus is on the European and Australian markets with a longer-term view towards IP respecting geographies.
- The purpose of the QA Officer role is to provide direct support to the Quality Assurance Manager in the management of the day to day aspects of the QA Department, including deviation close out and associated investigations, conducting self-inspections and participating in quality based projects.
- To effectively work within the QA department to ensure both QA regulatory and business requirements are met at all times.
- To work with other departments to ensure a strong QA culture throughout the business and providing guidance as required.
- Ensuring GMP compliance and GDP compliance
- Coordinate with commercial /Logistics for planning timely release of the batches.
- Coordinate with all departments to get the documents in time.
- Ensure batch documentation is obtained & reviewed on timely basis & provide necessary feedback to QPs for batch release.
- Ensure data logger information is available, Investigation of temperature excursion
- Ensure that the batches going to pack are in compliance with licence i.e. artwork of carton, leaflet & foil, expiry date, pack type & storage conditions.
- Maintaining QMS and comply with all the requirements like Change control, Deviation CAPAs, Training, Risk management documentation
- Responding to Quality related market complaints & documentation.
- Sampling, testing and Releases of Packaging Materials
- In-process, quality checks and internal audit compliance
- Leading Quality based projects working as part of a multidisciplinary team as required
- Responsible for supporting quality related customer complaint investigations and trending activities
- Supporting the development and implementation of improved quality reporting measures
- To promote continuous improvement of the Quality Management System
- Providing support and advice during cross-functional investigations / projects and as required
- Approving pre and post execution validation documents
- Able to conduct self-inspections and external audits as appropriate
Education and Experience:
- 2 years’ experience of working in a similar Quality Assurance related role in the Pharmaceutical Industry (preferably manufacturing)
- Knowledge of EU quality related pharmaceutical regulations
- Experience of conducting quality based investigations and root cause analysis
- Experience of conducting self-inspections
- Understanding of solid dose manufacture
- Understanding of Product Quality Review requirements
- Understanding and experience of Change Control
- Good communicator
- Good IT skills (Excel is a must)
- Decisive thinker able to work within agreed timescales
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 call Courtney Russell on +44 203 8141 315 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.