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QA GMP Specialist

TemplarFox Consultancy
Job LocationNewcastle Upon Tyne
EducationNot Mentioned
Salary£40,000 - £55,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

QA Specialist I am recruiting for a QA specialist for a pharmaceutical clinical development business based in the UK. This is an excellent opportunity to join an established business who’s growth and investment to deliver the first clinical trial product. The role willbe remote and support the development of QMS, suppliers and building a team.Purpose of the Role of QA specialist

  • Develop, manage, and maintain appropriate procedures to ensure regulatory compliance.
  • Support the development across the QMS. Deviations, CAPA, Change control, Audits, complaints, artwork and supplier qualification.
  • Liaise with customers and suppliers for issues, investigations and projects
  • Review and approval if CMO batch documentation and support documentation for QP.
  • Perform Quality Risk Assessments, manage quality risk management system
  • Perform and participation of customer Audits and regulatory audits
  • Comply reports for quality metrics - deviations, change control, customer complaints.
  • Adhere to and suggest improvements to the Quality Management System and GMP documentation
Requirements of the QA specialist
  • Experience working in a QA role in pharmaceutical business - GMP QA for 5 years plus, QMS Compliance
  • Knowledge of GXP regulations (ICH, EU, GMP, ISO, FDA etc).
  • Knowledge of electronic document management systems
  • Good communication skills to ensure information is taken, used and given at all levels for maximum benefit to the business.
  • Ability to travel to support the CMO, suppliers compliance.
If you believe you hold the relevant background experience and looking for a new role as QA specialist within successful and growing business then this is the role for you.About us: Templarfox is a privately owned recruitment business leading in executive search, management selection, Salary benchmarking and Business development services. The recruiter has stated that all applicants for this job should be able to prove thatthey are legally entitled to work in the UK and on this occasion TemplarFox Consultancy is acting as an employment agency.

Keyskills :
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