As part of the QA Operations Team, take ownership of all aspects of QA activities relating to the production and QA review of Products. Ensuring compliance with all applicable (EHS and GXP) regulatory and internal Quality standards and industry best practice are adhered to within the team. Be committed to, and passionate about, providing the highest quality standards within the team and across the business, whilst appreciating business needs.
This is a customer facing role, and as such the ability to form relationships across the organisation is essential for success.
Ensure you and the personnel (internal and external) operating under your remit comply with all applicable Quality, GXP and EHS.
Be responsible for closing out major and minor deviation records and leading major quality investigations where applicable.
Maintain an ongoing dialogue with Quality Operations Management to ensure quality target and objectives are able to meet business priorities.
Manage the Quality Management System including oversight of TW records.
Ensure customer complaints, Deviations, CAPA are completed and progress in a timely manner on the Quality Management System.
Identify and implement Quality System improvements where necessary
Lead a team of QA officers in the completion of their day to day activities, ensuring objectives, targets and workloads are achieved and distributed within the team appropriately.
Support the Manufacturing departments in handling deviations, CAPA and quality incidents.
Provide support and advice to internal departments to maintain and, where required, improve compliance to quality standards and processes.
Perform regular trend analysis of deviations, CAPA reviews and customer complaints to identify trends and suggest improvement strategies where required.
Highlight risk to product quality, patient safety and/or data integrity throughout the quality life cycle so that they are understood, transparent and can be managed through the application of quality risk management approach.
Deputise for the QA operations manager where required
Assist and lead in internal audits as part of the self-inspection programme and assist where necessary hosting regulatory audits on site.
Identify skills and competency development needs within the team. Support individual team development through the training and coaching processes.
Review and communicate key performance indicators for the team and implement actions to improve these where necessary.
Support Quality Operations Management in the identification, recruitment and on-boarding of employees into the organisation
Ensure that the performance of your direct reports meet the standards (competence and behaviours) required.
Escalation to the Quality Operations management, at the earliest opportunity, when issues or obstacles that impact on compliance or on time delivery.
All other tasks as duties, as necessary, to maintain the effectiveness of the Quality Operations activities as required by the business and/or Quality management.
- Agency: Cpl Life Sciences
- Reference: JO-2305-515918
Website: Cpl Life Sciences
- Posted: 12th May 2023
- Expires: 9th June 2023