Boston Scientific QA Specialist 

United Kingdom, England, Waverley 

201367370

United Kingdom-Farnham

To participate in and support activities in the Quality Assurance Department ensuring all goods manufactured and services provided by the Company meet the quality requirements of the Company, customers and regulatory authorities.

1. To coordinate and maintain all activities required for the disposition of finished product by Qualified Persons. This includes partnering closely with manufacturing / operations team; diligent review of batch records for pharmaceutical drug products.
2. To review, check and approve completed batch and ancillary quality documentation to ensure compliance with GXP and assist the disposition of finished product by Qualified Persons.
3. Liaise with external contractors and third party service providers regarding the review and approval of quality documentation.
4. Support in the supplier qualification, review and management processes as necessary as well as maintenance of the Approved Supplier List (ASL)
5. Prepare any required corrective and preventative actions related to the release of finished product.
6. To conduct reviews of artwork and label approval process for manufactured product.
7. To perform the release, shipment, quarantine and rejection procedures for drug finished product.
8. Support the product recall procedure and escalation process.
9. Co-ordinate the generation of APQR reports and communication with relevant SMEs.
10. To resolve customer enquiries and investigate customer complaints.
11. Perform internal audits and ensure timely completion of audits.
12. Track Key Performance Indicators for the quality system processes. Review and monitor trends, communicating out-of-norm issues to department management. Contribute to and assist in providing quality system training.
13. Provide input into the key quality processes of customer complaints, deviations, CAPA’s and change controls, assisting in root cause analysis, prompt responses/ resolution and ongoing data evaluation to ensure any emerging trends are acted on with the support of Quality Leads. Focus on Continuous Improvement opportunities.
14. Prepare and present quality reports, data and Key Performance Indicators to management for review at quality review meetings and Annual Product Quality Reviews.
15. Assist in the management of the SVMP to ensure adherance to the schedule and departmental objectives.
16. Assist in the generation, review or approval of other technical documents i.e. batch documentation and job plans.
17. Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with BSC values.
18. Carry out other reasonable tasks as required by the Line Manger.

The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

• Accountable to: QA Manager

• Internal: Liaise with all departments and Boston sites as necessary.

• External: Maintain external contacts e.g. suppliers, contract facilities and distributors, where appropriate.

• Educated to degree level or equivalent in an appropriate scientific discipline such as Chemistry, Biochemistry, Microbiology, Pharmacy or Life Sciences is preferred.
• Proven experience in an appropriate Quality role within the Pharmaceutical, Biotechnology or Medical Device industry.
• Demonstrated knowledge of Quality Management Systems and relevant standards (GMP, ISO, ICH, CFR etc.) within the medical device and/or pharmaceutical industry.

• Demonstrated advanced computer skills – Microsoft Office preferred.
• Excellent verbal, written and interpersonal skills.
• Demonstrated success working in a team environment.
• Competent, highly organised individual who pays strict attention to detail.
• Ability to work in partnership with personnel in the Site Functional teams, other sites and customers.