Senior QA Associate Operations Lead
3 weeks ago
Transforming Healthcare through Quality Excellence
Baxter, a global leader in pharmaceuticals, seeks a Senior QA Associate Operations Lead to join our Elstree, UK team. As a key member of our manufacturing operations, you will play a crucial role in ensuring the quality and compliance of our life-saving products.
Main Responsibilities:
- Support the batch review process to ensure flawless quality
- Release raw materials and components for processing, and finished products to market
- Investigate non-conformances, CAPAs, and complaints to maintain compliance with ISO13485 and FDA regulations
- Compile release data for finished products, including product bioburden, sterilization, and test results
- Collate, review, and complete batch documentation to support release
- Ensure closure of deviations prior to release to ensure timely release of product
- Document control: support document control activities, responsibility for filing/archiving completed DHRs and batch/order documentation
- Deviation management: support quality investigations to support release of finished product
- Liaise with Baxter staff and sub-contractors as appropriate to carry out investigations
- Quality Assurance/Control: adhere to Baxter policies and procedures at all times and notify any deviations/exceptions from process
- Support all aspects of the QMS through participation in internal audit and supplier audits
- Support investigations into incidents such as complaints, and any subsequent field correct actions/recalls
- Support regulatory inspections as required
- Support change control projects, new product development projects, sterilization validations, endotoxin testing, environmental monitoring, and purified water testing
- Manage the statistical process control (SPC) process for review of manufacturing and quality data
- Administrative tasks for supplier quality QMS, creation of part numbers, and update of Bill of Materials
- Participate in cross-functional project teams and attend meetings as a representative of Quality
Requirements:
- Degree or equivalent qualification in a scientific, technical, or engineering subject desired but not essential if you can demonstrate 2+ years experience in a GMP environment
- Experience working to ISO13485, FDA (21 CFR) part 820 or GMP (Orange Guide) compliant systems
- Experience in reviewing and releasing finished product to market or for final disposition
- Quality investigational tool training
- Familiarity with NCR/CAPA, document control processes within a regulated QMS, and auditing
- QA experience in cleanroom environments – sterile/aseptic manufacturing
- Field of expertise: QA, cGMP, and Quality Systems in an Operational Quality environment
- Knowledge of clean room control requirements
- Excellent communication skills
About Baxter:
Baxter is a global pharmaceutical company dedicated to saving and sustaining lives. Our products and therapies are found in almost every hospital worldwide, in clinics, and in the home. We have pioneered significant medical innovations that transform healthcare.
Join us at Baxter:
As a Senior QA Associate Operations Lead, you will be part of a close-knit team of 36 employees in Elstree, UK. You will have the opportunity to work on a wide range of projects, from batch review to regulatory compliance, and contribute to the success of our manufacturing operations.
What we offer:
Baxter offers a competitive salary and benefits package, as well as opportunities for professional growth and development. We are committed to creating a workplace where you can do your best work and make a positive impact on people's lives.
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