Product Labels Quality Assurance - Pharmaceutical
Role: 12 months contract (multiple headcount)
Assignment type: PAYE
Pay: GBP20/hour
Location: 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. Labelling experience in the pharmaceutical industry is highly desired.
Primary Responsibility:• 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.Competencies Required:• 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.