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
Experience:
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
Computer Literate
Education:
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.