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Senior Quality Assurance Auditor - GMP Group. (3 x vacancies)
At our Early Development site in Harrogate we are recruiting for a Quality Assurance Auditor (Level 3) to support compliance with Good Manufacturing Practice (GMP). The GMP QA Officer 3 is responsible for supporting the local implementation and operation of the GMP Quality Management System. The role aims to ensure the site remains in a state of GMP compliance by participation in investigations, audits, data reviews, validation projects and the delivery of GMP related training, etc.
The successful candidate:
- Reviews and approves departmental quality documents (SOPs, Policies, etc) to ensure compliance with GMP, Covance document management procedures and other applicable quality standards
- Performs regulatory review of study related documentation (i.e. batch records, protocols, reports, certificates of analysis, etc) prior to approval by senior GMP QA person
- Supports the GMP QA internal audit programme by participating in audits of GMP-related systems, processes and facilities
- Participates in projects providing recommendations to ensures facilities, utilities, equipment and computer systems are appropriately validated/qualified
- Conducts review of metrology methods and specifications for accuracy/relevance and compliance with appropriate quality standards
- Monitors the effectiveness of the GMP Quality Management System and provide trend data for input into the Management Review Process
- Participates in investigations (deviations, OOS, customer complaints, etc) to help assign cause and resolution of quality defects.
- Contributes to continual improvement initiatives aimed at improving the efficiency/ effectiveness of GMP operations
Significant experience in Pharmaceutical GMP environment; and / or significant experience in GMP QA.
In depth knowledge of GMP & Awareness of quality systems/standards,e.g. ICHQ10, ISO 9000
Good Communication/ Negotiation/Decision Making/Problem Solving Skills
Customer Service Orientated
Ability to Interact Effectively with Clients
Experienced GMP Auditor
Experience in process improvement
Ability to work with minimal supervision
Degree (or equivalent) in Pharmacy, Chemistry, Biology related discipline Relevent postgraduate degree (e.g. MSc) preferred
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.