Part-time opportunity for experienced QA professional. 3-day week contractor opportunity.
Great opportunity for suitably qualified QA candidate seeking a new challenge and flexible working arrangement in a fast-growing company at the intersection of the life sciences and technology industries. The selected candidate will be responsible for the coordination and implementation of the QA aspects of our client’s global clinical trials business.
• Overall responsibility for maintenance, delivery and improvement of company QA function.
• Review existing QA and QMS process, identify gaps and incorporate recommendations into SOP’s and other compliance documents (internal audit plans, company archive, and team training files etc.).
• Coordination with external regulatory experts and incorporation of suggestions into existing procedures.
• Identify process improvements to manage compliance risk and improve processes.
• Preparation and implementation of annual and trial-specific quality plans for the company.
• Liaise with Business Operations and Project Manager to help coordinate and align QA and project delivery objectives.
• Input into overall strategic objectives, performance and quality targets of the departments.
• Participate in pre-project planning and post-project reviews and process improvement initiatives.
• 3rd level qualification, preferably in a Science or Engineering discipline.
• Fluent English.
• At least 5 years experience in a pharmaceutical/CRO/Regulatory environment in a QA role Experience dealing with sponsors and Clinical Research Organisations.
• Familiarity with main Clinical Trials industry regulations and relevant guidelines i.e. ICH GCP, EU Clinical Trials Directive etc.
• Familiarity with relevant ISO 13485 and 21 CFR Part 11
• High attention to detail and strong organisational skills.
• Excellent communication skills.
• Flexible attitude.
• Pro-active, solutions orientated and highly motivated individual.
• PC Skills incl MS Word, PowerPoint, Excel etc.
Contact Brian Christensen on 01 6854747 or submit your CV to firstname.lastname@example.org for immediate consideration
If you would like further Information you can contact the recruiter directly:
Brian Christensen | Tel: +353 (0) 1 685 4747