A role exists for a Senior Quality Assurance Associate to join a vibrant QA team. Woking as part of the QA team you will be driving the development, implementation and maintenance of the quality assurance program to ensure compliance with relevant GLP and GCP requirements.
Key Tasks will include:
• Manage the planning and conduct of study audits to ensure that data are being reported in accordance with applicable regulatory and organisational procedures:
o auditing of Laboratory space (GLP plans, data and bioanalytical reports)
o auditing of Clinical space (GCP databases, Trial Master Files and Clinical Study Reports, Investigator Study Sites)
o facilitate internal facility, process and vendor audits
• Plan and audit Investigator Site against relevant ICH-GCP, Study Protocol and site SOP’s.
• Ensure regulatory compliance ie FDA, TGA, NATA
• Participate in CAPA investigations
• Coordinate the preparation, review and issue of internal SOPs
This is a fulltime permanent role with an immediate start for the right applicant, business hours expected 9am-5pm weekdays. Join a young and vibrant team and put your quality/regulatory expertise to best use.
Skills
• A tertiary level qualification in science
• Extensive senior auditing experience in a GLP &/or GCP regulated environment ie pharmaceutical, bioanalytical
• Formal auditing training or equivalent experience
• Experience in preparing/writing formal documents ie reports, SOPs
• Excellent written and verbal communication skills
• Demonstrates attention to detail and high level of accuracy
• Demonstrated ability to influence and negotiate
• Ability to build and leverage rapport with all levels of staff
• Energetic, Proactive, Self-managed and organised
• Ability to work in a high pressured environment
• Ability to hit the ground running
• Approachable and flexible
Benefits
• Further Training and Development
• Flexible work environment
• On-site parking
• You'll be 100% backed by an enthusiastic team.
Send resume to tehreem@jobs-n-jobs.com
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