Quality Lead - Slough, United Kingdom - Star OUTiCO

Star OUTiCO
Star OUTiCO
Verified Company
Slough, United Kingdom

2 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

Quality Lead:


Office Based:


Star OUTiCO is recruiting for an exciting opportunity as a Quality Lead Our client is an international biopharmaceutical company, who are passionate about promoting health and wellbeing for all by developing a portfolio of innovative, next-generation products.


Key Responsibilities:


  • Implementation and maintenance of the Quality Management System (QMS), including SOP generation and review, ensuring compliance with GDP regulations
  • Provide the Leadership Team with regular reports regarding the Company's Quality KPIs, including CAPA plan
  • Deviation and change control management, training, outsourced activities, and selfinspections
  • Conduct supplier checks, approvals and audits, ensuring adherence to the relevant GDP/GMP standards.
  • Ensuring the correct GDP training programmes are rolled out to both new starters as well as existing employees within the business.
  • Line management of QA/RA Associate with defined delegation of QA and RA responsibilities, keeping appropriate records of these delegated duties
  • A bachelor's degree in pharmacy, chemistry, or other related field, with a strong understanding of GMP and GDP principles
  • Minimum of three years' experience as a Responsible Person in a pharmaceutical environment
  • Previously named as an RP/RPi on a WDA licence.
  • Accomplished and experience in conducting internal audits and hosting regulatory inspections
  • Excellent knowledge of EU & UK GDP, GMP, and regulatory requirements for pharmaceutical products
  • Excellent communication, organisational and leadership skills

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