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Quality Assurance Manager
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: Effectively manage all Quality Assurance aspects of the Quality Management System to ensure that processes and procedures are in compliance with ISO9001; ISO13485; 21 CFR 600; IVDD 98/79/EC and other appropriate regulations and standards. This includes site safety requirements and applicable Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
Essential Job Functions:
- Management and development of robust and compliant QA processes for the following functions:
- Batch Review and Release
- Incoming Inspection
- CAPA and Non-Conforming Systems
- Document Control System and Change Control
- Internal Audit Program
- Supplier Quality
- Complaint Management
- Development of cross functional and collaborative relationships within the facility to support Manufacturing deadlines and product delivery schedules. Coordinate team activities to meet product planning and release schedules.
- Development of effective internal and external customer relationships to ensure quality and regulatory compliance for the business.
- Accountable for the review of quality records for compliance to required standards and oversee Batch Release process to ensure product release in a timely manner.
- Provide guidance and expertise for investigation of failures and participate in CAPA and continuous improvement initiatives.
- Preparation of quality reports, data and Key Performance Indicators for presentation to senior management as required and as an input to Management Reviews.
- Management of the facility internal and supplier audit program to ensure timely and effective execution of audit.
- Development of a risk based Supplier Management process in conjunction with other relevant departments.
- Development and execution of an annual GMP training program(s) for all personnel in addition to an induction GMP training program for all new employees.
- Any other activities as required to meet the needs of the department and / or business.
Who you are:
- Batchelor’s Degree in Science (Chemistry, Biology, Medical Technology) or equivalent professional training.
- Extensive experience in a drug manufacturing, medical device, biologics or related industry.
- Must demonstrate expertise in GMP, FDA regulations, SOP development, as well as an understanding of Quality Assurance audit functions and Quality principles.
- Experience of managing and motivating personnel, managing by objectives and conducting personnel appraisals/performance reviews.
- Six Sigma Qualified (Green Belt or above).
- Strong analytical and problem solving skills.
- Competent in the use of IT technology such as Microsoft Word, Excel and Powerpoint.
- Good communication skills with the ability to collaborate and present at all levels and functions of the organization.
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