Quality Assurance Supervisor-QMS -ISO 13485-GMP-IVD - Biotechnology - CAPA - Audit - £40-45K + Bonus + Excellent benefits
A Quality Assurance (QA) Supervisor is required to join a leading biotechnology company. IN your position Quality Assurance Supervisor you will be required to lead the company's QMS implementation and improvement. You will have a small team to supervise and as such it is required that you do have prior supervisory or management experience. It is essential that you have significant QA experience gained within an ISO 13485 environment and sound knowledge of GMP.
As QMS Supervisor you will champion the implementation, improvement and continuation of quality assurance practices in support of products manufactured and / or sold by the Hampshire site and lead a small team of QA personnel in support of the site QMS. This role will partner with internal stakeholders to drive continual improvement of quality and compliance in all areas including Quality Assurance with a focus on quality systems.
You will assist in facilitating SOP management and procedural adherence, training efficacy, change controls, validation, CAPA and product recalls. It is the responsibility of the QMS Supervisor to ensure the quality improvements resulting from audits are completed and documented and that their team meets the QMS objectives for the site. In addition, this role is responsible for the execution of internal and external quality audits / assessments at the Hampshire site including the planning, reporting and CAPA activities resulting from internal, supplier, customer, Notified Body and Regulatory Authority audits.
*Prepare the annual audit plans and carry out internal and external quality audits to ensure compliance with ISO 13485, ISO 9001, FDA 21 CFR 820 and the European IVD Directive.
*Organize and host customer audits.
*Coorindate and minute site management review meetings.
*Ensure that product quality is maintained throughout the manufacturing process by quality audit / assessment and implementation of recommended quality improvements.
*Investigate Quality Notifications (Customer complaints).
*Load product formulations and SOPs onto SAP as and when required.
*Act as training Co-ordinator for MasterControl - Electronic Document Management system.
*Manage the change control system.
*Provide Quality input to product-related investigations, deviations, change controls, validation protocols, validation reports, and SOPs.
*Work closely with Operations, R & D, Purchasing and Engineering to improve quality while reducing material scrap and costs.
*Assure that site standards comply with division policies, national and international codes, and applicable safety requirements.
*Provide QA oversight of CSV activities pertaining to e-QMS applications.
*Review and approve validation documentation.
*Effectively lead a team of QA members in the maintenance of existing QMS and implementation of system improvements
*Ensure the internal audit programme is maintained appropriately.
*Effectively lead a team of at least 3 QA members in achieving department and individual team members' objectives.
*Bachelor's degree preferred in science discipline (chemistry, biology, etc) or related field.
*Medical device (ISO 13485, 21 CFR 820), or GMP (21 CFR 820, 210, 211, Eudralex) background.
*Experience in auditing practices and principles; formal internal and external auditor training required.
*Demonstrated working knowledge of compliance, quality and scientific principles.
*Strong oral and written communication skills.
Willingness to undertake on the job training in all areas of the product supply chain.
Demonstrated ability to work effectively as a member of a cross-functional team.
*Strong working knowledge of quality related tools, such as structured problem solving, FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control), DOE (Design of Experiments) and Six Sigma / PPI.
*Strong working knowledge of various computer software, such as SAP, MasterControl, as well as Microsoft Word, Excel and PowerPoint.
*Experience with lean manufacturing practices.
*Develop others as well as self.
Non-Negotiable Hiring Criteria:
*Proven experience in supervising a small team.
*Medical device, GMP, EU Regulation or ISO 13485 background.
*Significant experience in administering quality systems such as change control, CAPA, training, etc.
*In-depth experience in the development and implementation of electronic Quality Management Systems such as CAPA, change control, training, documentation, etc.
*Strong working knowledge of various computer software, such as SAP, as well as Microsoft Word, Excel and PowerPoint.
*Excellent oral and written communication skills.
*Strong leadership skills with the ability to challenge, influence, and build consensus.
*Strong quality background and problem analysis and decision-making skills.
You must be eligible to work in the UK. Learn more
- Agency: Cranleigh Scientific
- Posted: 7th December 2017
- Expires: 4th January 2018
- Reference: BBBH48841