Product Labels Quality Assurance - Wirral, Merseyside, United Kingdom - Gibbs Hybrid Programme Solutions & Consultancy

Description

PAYEPay: £20/hourLocation: Wirral – hybrid working 50/50 My pharmaceutical client based in Moreton (Wirral) requires a number of QA Specialists to join a team who are responsible for assuring the quality of labels on pharmaceutical drug products.

• Reviews company's own and label vendor specifications in accordance with relevant regulatory requirements for assigned projects.
• Review and approve vendor generated label proofs/specifications and other related documents.
• Utilizes electronic verification software to perform check on label proof. Routes final label for review and approval accordingly.
• Work cross-functionally with individuals and project teams. Other Responsibilities
• Performs specific quality related functions such as Quality/GMP training, materials/products releasing, validation, quality incident investigations to ensure compliance with GMP regulations and company standards.
• Supports in the investigation of non-conformances and quality incidents. Resolves and documents any deviation or problem pertaining to the audit of documents.
• Reviews and approves documents related to Quality Systems such as validation protocols/reports, change control, or Procedural Documents to support the release function.
• Support internal and/or external audits as required.
• Participates in assigned training including GMP and safety training.
• Ensures regulatory, GMP, GDP compliance of activities in assigned areas of responsibility. Reports any deviations to the appropriate management.
• Liaises with responsible Trial Supplies Manager on aspects of clinical supplies packaging and labelling design and study requirements and resolves issues

• Ability to plan, manage and execute multiple projects and to deliver against critical timelines in a fast-paced, rapidly changing environment.
• Attention to detail and a strong ability to concentrate
• Exceptional project management skills and detail oriented.
• Possesses solid oral and written communication skills.
• Good decision making and organizational skills.
• Ability to effectively communicate ideas and to influence others to achieve results.
• Ability to understand and apply regulatory and CGMP principles.
• Good understanding of pharmaceutical or medical terminology
• Proficiency in standard office technology, including Microsoft Suite (Outlook, PowerPoint, Excel) Additional applications such as Adobe. Willing to learn additional applications as needed.
• Experience working on multi-disciplinary teams and projects.
• Good knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (e.g., revision control) is preferred.