Sector: Life Sciences
Consultant: Life Sciences Team
Job Status: Contract / Full Time
Exciting opportunity 9 month contract looking for someone with an extensive understanding of Medical Device Quality and the quality systems around it.
Quality Specialist (Life Sciences)
- Closely interacts and builds effective relationships with people across site to promote quality, consistency and compliance. Provides quality support to manufacturing and NPI projects. Demonstrates courage and willingness to determine appropriate action and make risk-based, sound and timely decisions. Ensures and maintains compliance with internal and external (ISO 9001, ISO 13485 etc) standards and regulatory requirements.
- Identifies and drives improvement opportunities with areas through effective communication and ensures where quality issues arise that root cause is deternied and the appropriate actions are agreed and implemented. Manages corrective and preventive action processes ensuring the timely and accurate resolution of problems identified.
- Takes responsibility for the measuring and monitoring of performance against agreed KPI’s. Collates and shares information/data and trending as appropriate through reports and follows up on improvement opportunities. Actively participates and/or drives EU/Global QMS improvements as required. Actively contributes to the success of the overall QA team and the site. Identifies, advise and implements training/coaching to meet defined Quality Systems requirements.
- Performs/takes part in internal audits and external audits as required according to site and global plans.Uses auditing as a proactive tool for improvement as well as compliance and challenges existing practice where appropriate. Takes responsibility for ensuring timely completion and follow up through to closure.
- Participates in personal development to further enhance skills and knowledge relevant to the position. Supports and maintains Company’s Safety, environmental and Waste Management programme.
- Degree in a scientific discipline or equivalent experience in a relevant discipline
- Knowledge of ISO 13485.
- Quality Assurance / Auditing experience in a chemical, pharma or manufacturing industry. Lead auditor status is preferred.
- Experience in the one or more of the following – training, validation, problem solving tools. Understanding of statistics based management & procedure is preferred.
- Excellent MS Office skills in particular Excel (Trackwise and Statistical Software or comparable experience)
- Coaching skills – in order to support and help to improve on site
- Ability to perform duties with minimum supervision.
- Ability to work on a variety of assignments at one time.
- Ability to recognize deviation from requirements and standard practice and understanding associated risks is essential in role.
- Good communication skills (spoken and written)