Our Client is a leading Clinical Trial Services Provider and due to expansion they are looking for a Quality Officer to join their team on a part time basis (Approx 20 hours per week).  This role could lead to a full time role in the future. 

The Quality Officer is the local support for all quality matters including implementation of quality procedures, standards and specifications across all activities, auditing to ensure compliance and making sure corrective actions are taken to minimise future occurrences. Supporting and building the capability of the team to effectively engage, inspire, motivate all stakeholders to the QA strategy, advocating the company’s values and culture.

Responsibilities

• Assist in implementing global QA strategy locally that outlines goals for activities such as building effective QA procedures, and audit standards and ensuring consistent application, making sure appropriate corrective actions are conducted to minimise future occurrences.
• Conduct Quality Management System training: procedures, GxP training, and onboarding training locally.
• Assist in client’s external audits, providing documentation required during external audits and assessments, and providing responses concerning observations that occurred during external audits.
• Approve non-conformity investigation and control its timely closure. Perform Follow up actions.
• Approve change control and control its timely closure. Perform Follow up actions.
• Prepare Supplier’s audit plans/schedules and assist in audits of suppliers, preparation of audit reports, and control of CAPA implementation.
• Evaluate and re-evaluate annually the Vendors/Suppliers.
• Prepare internal audit plans/schedules, conduct internal audits, and preparation of internal audit reports.
• Control of timely closure of Corrective and Preventive Actions locally.
• Participate in the review and approval various documents.
• Ensure that all operations are performed according to the applicable standard procedures, working instructions, ISO 9001, GxP requirements, and legislation requirements.
• Control of timely update of local SOP, WI, SF and other QMS documents, notify the QMS Document owner when the document is due for review and provide with editable version.
• Check and approve Periodic System Evaluation report.
• Manage electronic versions of QMS Documents on server (timely move files to the appropriate folder: Effective, Superseded, Cancelled).
• Vendors/Suppliers management: creating Vendor/Supplier cards in DMS, sending for approval of start and suspension of cooperation.
• Audits of Clients and Suppliers, Internal audits Registration in
• Client Technical Quality Agreements uploads in the system.
• Monthly coordination of on time training for UK Employees

Qualification and Experience  

• Higher education (bachelor’s degree or equivalent).
• Relevant, demonstratable experience in a similar level role (QA experience of at least 2 years - pharmaceutical or food industry desirable).
• Knowledge and experience in global, multi-site, multi-cultural organisation
• Excellent national and international QA systems experience Skills, Knowledge, and Qualities
• Good knowledge of Microsoft Excel and Word applications
• Good commercial acumen
• Fluent in English language written and verbal.
• Engage and build credibility with internally influential individuals.
• Exceptional attention to detail that delivers quality information.
• Reliable, punctual, and organized.
• Ability to effectively adapt to change to deliver a quality service.
   

Please apply online or contact Ark Talent Group for further information.