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Product Safety Engineer
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Quality Assurance Specialist - Moreton, Merseyside, United Kingdom - Gibbs Hybrid Programme Solutions & Consultancy
Description
QA SpecialistMoreton, GB (Hybrid)12 Month Contract – Likely Extensions/ permanency£20 per hour FunctionPDQ Good Manufacturing Practice (GMP) serves as the Quality Assurance Unit overseeing manufacture, testing and distribution of clinical supplies (investigational products) to assure quality and compliance with Good Manufacturing Practices (GMP) and other applicable regulations and internal procedures.
Key responsibilities include drug substance and drug product batch disposition (release/reject decision), product certification and release by the UK/EU Qualified Person, and audit of internal GMP systems/processes and suppliers/third party contractors, as well as assist stakeholders with regulatory advice and preparation for and management of regulatory agency inspections.
Primary Responsibility:
Review 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 ResponsibilitiesPerforms specific quality related functions such as Quality/GMP training, materials/products releasing, validation, quality incident investigations to ensure compliance with GMP regulations and 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.
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 terminologyProficiency 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.
Experience:
Bachelor's degree or equivalent in pharmacy, engineering, or life sciences.
Relevant experience in the pharmaceutical industry or related healthcare environment.
Labelling experience in the pharmaceutical industry is highly desired.
If you are interested, please do not hesitate to apply Either apply direct or reach out
