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A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Your role: As Quality Assurance Supervisor you will be responsible for management and oversight of the daily operations of the Quality Assurance Group. You will manage site quality and cGMP activities and compliance. This compliance to be maintained with the implementation of global policies and effective SOPs and systems, validation of test methods equipment and processes, cGMP training programs and effective auditing and self-inspection programs. Lead and develop QA personnel and develop Best Practice cGMP systems.
- Assists the Quality Manager in overseeing and managing all Quality Assurance Systems within the facility. Support the preparation of annual work schedules.
- Lead and support the use of Daily Management System to manage team.
- Supervises the Quality Assurance Staff activities and manages the day to day QA operations to ensure that assigned tasks are performed in a compliant manner within assigned timeframes. Complete Performance Management and Staff appraisals.
- Investigation reporting including Process Deviation, OOS, Material failures and customer complaints.
- Review and approval of batch related documentation and final product release.
- Provide Regulatory and cGMP leadership to all Site and Business Unit Functions.
- Provide QA input to (and manage, as necessary) company validation programs.
- Ensure the cleaning validation protocol and programs are progressed in accordance with current cGMP norms
- Complete QA audits, inspections and investigations in a timely manner consistent with shipping deadlines.
- Investigates customer complaints and regulatory queries thoroughly, in a timely manner and ensure that all corrective and preventive actions are fully implemented.
- Preparation of APRs, DMFs and other recurring cGMP requirements in a timely manner.
- Oversee the Plant Documentation and Change Control system including drafting of SOP’s, Monographs and Master Batch Records.
- Provide continuous improvement leadership in QA activities to secure process efficiencies and enhancements.
Who you are:
- Degree, or equivalent, qualified in a relevant life science. Masters level qualification would be beneficial.
- Extensive supervisory experience in a Quality environment with demonstrated leadership behaviours; Ability to positively influence colleagues.
- Significant experience at Senior Quality level, in a FDA regulated company, experience in a global role.
- Broad experience of regulatory and cGMP activities.
- Proactive Individual with Change Agent Capabilities with ability to identify, plan and implement improvement activities.
- Knowledge of Deviation, CAPA, Audit, Change Control and Customer complaint Trackwise Modules and SAP.
- Knowledge of ISO9001:2015
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com