QA Specialist - Biopharma - 7am-3.30pm
Could be some quite nice working hours for some - 7am - 3.30pm. (Some support may be required outside of these working hours on occasion)
Duties to include
- To assist in the creation, review, approval and closure of deviations, investigations, CAPAs, change controls and associated quality risk assessments in compliance with internal and external requirements
- Identify opportunities and support continuous improvement of enterprise QMS processes and associated systems
- Monitor QMS process performance to identify trends and best practices
- Author, review and approve of QMS procedural documentation and work instruction
- Create and deliver Quality Systems training (process and technical)
- Compile and present QMS monthly & quarterly metrics at Quality Management Review
- System user access management
- Participate in inspection readiness activities and internal/external audits and inspections.
- 5 years’ + QA experience within the pharmaceutical industry
- Significant, direct experience with development and approval of a minimum of two of the following: Deviations, CAPAs, Change Controls and quality risk assessments
- In-depth knowledge of global cGxP requirements for quality systems
- Experience working with stakeholders in pre-commercial, manufacturing, laboratory and distribution functions
- Excellent communication skills with all levels of the organization and Health Authority representative
- Knowledge of medical device quality system requirements desired
- Direct experience with TrackWise desired.
- Project Management and Lean Six Sigma certifications a plus.
- Qualified Person designation a plus.
- Bachelor’s degree in a technical or life sciences discipline
Call me for more information on this vacancy !
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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