Essential Duties and Responsibilities

• Sampling of intermediate products within the manufacturing process.
• Testing and inspection of product, as required by SOP and Finished Product Specification.
• Co-ordination of product testing with external contract laboratories.
• Maintain compliance with ISO 13485 and FDA (21 CFR) part 820 and the requirements of MDSAP.

Product Release:

• Compilation of release data for finished products.
• Co-ordination of product bioburden data.
• Collation and completion of documentation to support release.
• Inspection of sterilized finished product received back from subcontractors.
• Support to releasers for disposition/release of finished product.

Goods Inwards Quality Control:

• Inspection of goods and material dispositioning.
• Co-ordination of investigations into non-conforming product.

Calibration/Maintenance Control:

• Support of calibration, maintenance and revalidation activities for equipment and facilities.
• Monitoring of schedule and tracking execution of activities.

Quality Assurance/Control:

• Adherence to Baxter Elstree’s relevant policies and procedures at all times, and notification of any deviations/exceptions from process.
• Support for all aspects of the QMS through participation in internal audit as trained and approved auditors and support for incidences such as complaints, and any subsequent field corrective actions/recalls.
• Support for and co-ordination of Quality Investigations i.e. NCR/CAPA/Complaint handling, and logging/issuing of QMS numbers.

Experience / Qualifications

• QA, cGMP and Quality Systems in an Operational Quality environment. Knowledge of clean room control requirements. 
• Bachelor’s degree in scientific or technological subject
• A minimum of 2 plus years’ experience required in the areas of GMP regulations that pertain to the medical devices / pharma / biologics - Quality, Manufacturing, Engineering or related field which where possible 1-2 years of supervisory experience is preferable
• Internal Auditing experience. Familiarity with NCR/CAPA, complaint and document control processes within a regulated Quality Management System.
• Working in a fast paced, rapidly changing environment, supporting new product introduction.
• Excellent investigational, analytical and problem solving skills. Ability to review and monitor data, and identify trends.
• Highly proficient communicator, both verbal and written.
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