Quality Assurance Associate
Req #: 1800028W_en
Location: Oxford, ENG UK
Job Category: Quality
Date Posted: 2/14/2018 10:51:32 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 main role and responsibilities of a Quality Assessment Associate will be to work closely with the manufacturing team to ensure the QA Unit meets Customer expectations on the delivery and the quality of the product prescription release. As a QA you will be responsible for the release of product on the system and will be supporting production in the review and post compounding check operation. You will be interpreting data, checking and validating prescription and product release ensuring errors picked up and rectified. You will ensure that the unit is compliant with corporate processes, policies and procedures.
Responsible for release activities associated with products manufactured at the compounding units.
Ensuring that all changes are completed fully as per impact assessment and in the appropriate time frame
Ensuring all equipment used for the manufacture and storage of product is re-validated as required per the validation master plan.
Ensure that a schedule of environmental monitoring is in place that complies with GMP and that any out of limits or alerts are investigated and actions taken to correct.
Track and trend on a monthly basis quality system data and indicators, including but not limited to Exceptions, Errors and Complaints. Trending should include timeliness in completion as well as actual numbers
Manages the audit process for the facility, organisation of the management team and staff to ensure a successful audit
Ensures all quality records are reviewed and that they are complete, comprehensive and legible and comply with good documentation practice.
Skills and Experience
- Science Degree – Pharmacy / Chemistry / Microbiology OR Btech in Pharmaceutical Science or equivalent
- Must have demonstrable skills and experiences doing a very similar role
- Drive, Right attitude and professionalism within previous roles
- Check, validation, calibration, documentation experience is preferable
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.