2mesjobs 2M Employment Solutions Ltd
As a GMP/GLP compliant laboratory with over 50 years of experience, Wickham Laboratories Ltd is an established name in the fields of pharmaceutical and medical device contract testing, research and consultancy.
Quality Assurance Technician
We currently have a full-time vacancy for an experienced Quality Assurance (QA) Technician with a proven background in GMP standards.
Working hours would be 37.5 per week, Monday to Friday. Occasional weekend working might be required.
• Good organisational skills
• Clear and effective verbal and written communication
• Lead auditing skills
• Ability to review data accurately
• Ability to manage own work and work as part of a team
• Ability to prioritise and work well under pressure
• To work in compliance with GLP, GMP and the policies and procedures of our Quality System.
• Assist in issuing of controlled documentation
• QA review of technical Protocols, Final Reports and raw data
• Assist in the QA review of Out of Specifications (OOS), Non-Conformance Reports (NCR), Corrective and Preventive Action (CAPA)
• Undertake the QA review and approval of Risk Assessment , Change Control, IQ, OQ, PQ and Post Implementation
• Update Quality databases and produce data reports and KPI’s monthly
• Assist in QA checks of internal Booking and Reporting System
• Lead internal inspections/audits of departments for compliance with Good Laboratory Practice, Good Manufacturing Practice and other quality standards
• Review and undertake supplier audits as part of the supplier approval process
• Provide support to initiate, engage and escalate critical and major compliance issues through the QMS processes
• Participate in client / regulatory inspections
• Degree (or equivalent) in a life sciences subject would be desirable.
• Proven and significant experience within a GMP environment. GXP experience would be an advantage.
• Knowledge of the MS Office suite and Outlook, in particular Excel is essential.
• Experience of computerised systems would be beneficial for future implementation of electronic Quality Management System (QMS) is desirable.
• Previous knowledge of QMS and an understanding of auditing is essential.
• Up to £25K depending on qualifications and experience (please state salary expectation when applying)
Please click ‘apply’ to forward your CV.
Wickham Laboratories Limited is an Equal Opportunities Employer.