Website Asset Recruitment
Reporting to the Head of Quality Systems, the Quality Systems Specialist will be responsible and accountable for oversight of the main quality systems for SOP management, training, deviation management, CAPA, and change control. This includes processing of documents, driving and following up on quality workflows, document review and approval, as well as training management.
Essential Duties and Responsibilities
• Responsible for processing quality documents, e.g. SOPs and Forms, in the document management system MasterControl.
• Setup and maintain a robust training system with clearly defined and assigned job codes, training content and success controls. Request regular training status checks by responsible department heads.
• Manage the process to request trainings and assign trainings to new employees/ employees with changed responsibilities.
• Provide oversight of deviation management, CAPA and change control in Trackwise. This includes review of content with regard to GDP requirements, clarity, conpleteness and quality of root cause analysis, as well as follow-up of timelines and completion of open actions.
• Ensure GMP documentation, both paper and electronically, is prepared and archived in compliance with industry standards and regulatory expectations. Create and maintain oversight of archived documents, copies and review or retention periods, as applicable.
• Lead by example and ensure documentation and trainings are performed by complying with all applicable standards, rules and regulations.
• Liaise actively with other functional areas and provide support/ advice to ensure standards are met. Actively communicate with stakeholders and report issues within established reporting lines.
• Actively participate in internal and external audits as SME for documentation, training, and the quality systems for deviations, CAPA and change control.
• Perform all activities in compliance with applicable safety standards and SOPs
• Participate in other duties as assigned.
• Experience in GMP documentation and training management, as well as GDP practices.
• Experience with change control, non-conformance management, corrective and preventative actions, and SOP writing in a GMP regulated environment.
• Minimum of 3 years’ experience working in a Biologics or similar GMP environment as part of a quality, technical or operations function or other combination of experience and educational background that may otherwise satisfy the requirements of the role
• Previous experience with quality systems and processes, preferably working in a green field environment.
• Experience working in Quality Assurance role in a GMP Life Science environment.
• Demonstrated understanding of principles of Good Documentation Practice and GMP requirements for training.
• Strong knowledge of GxP regulations (e.g. EU-GMP Guideline)
• B.Sc or B.Eng in a Scientific or Engineering related discipline preferred.
• Strong organisational, communication, coordination, and meeting facilitation skills
• Excellent interpersonal, verbal, and written communication skills
• Good critical thinking skills and troubleshooting to drive improvement and build opportunities
• Self-starter and self-motivated; organized with good attention to detail
• Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities
• Results oriented, with the ability to manage multiple priorities in a short period of time
• Collaborative and inclusive approach to work and your colleagues
• Engage cross functionally in conjunction with a site-based team
This is a 6 months contractor role and the client can extend it for another 4 or 6 months with 2 weeks’ notice in advance.