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QA Specialist
3 months ago
Location:
Biopure - Havant
Benefits:
Enhanced Carer/Paternity Leave, Additional Holiday, EAP and more
We're currently seeking a QA Specialist - PureSU to join us.
You'll join a dynamic team of engineers, sales people, marketers, administrators, designers, assemblers, chemists, web developers, accountants, analysts, programmers and many more.
Globally we are united by our shared values that drive our culture. We want to be an employer where you make our difference.At Watson Marlow Fluid Technology Solutions you face different challenges every single day. You are empowered to dream bigger and work smarter. You have time to live your life outside of your job.
We offer a full induction with training and ongoing support for all our systems and products. Along with this you'll gain access to SSE academy where you can upskill and develop at your own pace.
This role will focus on:
This role is responsible for ensuring our single-use assembly products (PureSU) meet the required quality standards for our customers.
Reporting to the Biopure QESH Manager, this will be a key role working with the wider global PureSU team across Watson-Marlow Fluid Technology Solutions (WMFTS).
The role will initially be focused on ensuring quality documentation and processes comprehensively meet ISO 9001 with the aim of achieving ISO 13485 certification in the near future.
Key Accountabilities include:
- Driving quality assurance in PureSU assembly operations. Holding people to account for quality within their remit of responsibilities.
- Creating, updating and maintaining documentation within the QMS. Writing policies and procedures in collaboration with the PureSU team.
- You will be responsible for ensuring Good Documentation Practices are upheld for PureSU, along with archiving and retrieving batch documentation.
- Ensuring ongoing compliance to support critical product claims e.g. adherence to the sterility assurance programme. This includes reviewing and approving reports for test reports from external organisations and raising any issues/concerns promptly to the Validation team to assess impact.
- Promoting the importance of quality across the PureSU organization and associated functions/departments.
- Addressing customer requests for compliance statements quickly and working with the validation team to support requests for regulatory/validation data.
- Raising Non-Conformances on receipt of complaint and communicating to relevant teams for investigation.
- Maintaining and updating calibration records for equipment where necessary.
- Generating change controls from internal and external communications. Working with Product Management on Change Notifications relevant to PureSU.
- Hosting customer audits for PureSU with support from the wider Quality team. Conducting/supporting external supplier audits as required. Undertaking internal audits and ensuring audit actions are assigned and completed.
To be successful in this role, you will need:
- A strong track record of experience in Quality Assurance roles within manufacturing/engineering environments. If you have any life sciences (e.g. biopharma, pharmaceutics or medical devices) even better
- although this is not essential.
- Any experience of working within an ISO 13485 quality management environment is desirable.
- Strong attention to detail and very high level of integrity.
- Good communication skills and the ability to influence.
- Experience of Internal Audit training, Lead Auditor would be preferable.
- Experience of ERP system Microsoft AX and eQMS system TrackWise.
Closing date:
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