International QA Auditor

Location: Scotland  |  Scotland  |  United Kingdom
Sector: Life Sciences
Consultant: Matthew Pitcher
Job Reference: SVJ089
Salary: £40000 - £60000
Job Status: Permanent / Full Time

We are excited to be working with this fantastic client, looking for a International QA Auditor, this role is based in Scotland and would be perm office based position.

Job description

 

  • To Carry out GXP audits for CMO, Suppliers, Service providers etc 
  • Key Responsibilities: (what are the tasks, duties and responsibilities?)
  • To prepare annual audit plan.
  • To carry out GXP audits of suppliers, CMOs and Service providers
  • To carry out self-inspection of affiliates and our departments.
  • To support for hosting GXP audits.
  • To review and approve stability, validation, tech transfer and technical protocols.
  • To carry out GXP trainings.

Key requirements

 

  • A Life Science degree or equivalent
  • A broad experience of working within the Pharmaceutical industry of which several years should have been in QA GMP auditing.
  • Excellent working knowledge of international GxPs, especially in the interpretation of MHRA and FDA requirements, for the manufacture, control and distribution of commercial product and clinical trial materials
  • Sound knowledge of the principles of solid and semi-solid dosage manufacturing processes (tablets, capsules, gels, creams, ointments)
  • Sound knowledge of QC and Stability chemical analytical testing techniques for solids and semi solids
  • Familiar with the regulatory requirements for validation activities as applied to manufacturing and packaging processes, analytical methods, cleaning procedures, computerised systems
  • Familiar with the appropriate EU Directives, EU and USA regulatory processes, ICH Guidelines
  • Familiar with Quality Management Systems e.g. ICH Q10
  • Regular Worldwide travel (50-70%)

About you

 

  • Good interpersonal and communication skills
  • Sound technical knowledge of Pharmaceuticals
  • Good analytical and problem solving skills
  • Good writing and presentation skills
  • Team working and team development
  • Working experience of Quality Systems
  • Ability to operate in a “virtual” pharmaceutical environment
  • Maintain a high visibility and credibility with management and staff