Quality Assurance Officer
Req #: 180001U3_en
Location: Thetford, ENG UK
Job Category: Quality
Date Posted: 2/20/2018 9:51:10 AM
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
The role of the Quality Assurance Officer is to work within Compounding Unit checking the product to allow for its release. In this role, you will be responsible for the release of batch, production complaints, deviations, change controls, updating emails and review of SOPS. You will also responsible for the morning fridge rota which is the release of product whilst in the cold room. The product is manufactured outside of QA hours and stored in a cold room which means there is a backlog of product waiting on release. There will be approx. 100 plus batches released a day and 24 validations from the compounding unit. There is also an element of lifting in this role which is done on a rota basis and is predominately on the production floor with only 25% in office.
Support delivery of product release targets
Lead and support the execution of timely deviations and investigations
Support the preparation & development of Annual Product reviews
Support validation programs and change control implementation as required
Ensure that the facility is always ready for a MHRA, corporate, an internal or 3rd party audit and ensure that audit findings are fully investigated and actions are managed in a timely manner to address the issue.
Regularly communicate with all site staff quality issues and promote the Quality System as a business process for improvement of customer satisfaction and regulatory compliance
Monitor all Quality System processes to identify improvement opportunities;
Ensuring product complaints are adequately investigated and appropriate corrective and/or preventative actions are implemented
Providing QA oversight to product and process changes and validation and Maintain a local change control process to ensure all changes are fully documented;
Skills and Experience
Must have QA (not QC) experience
Must have GMP experience (MHRA requirement)
Must have Pharma/science qualification – Btech or higher
Aseptic or clean room experience ideal
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, colour, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.