GMP Quality Auditor

Location
Remote working in the UK and some office work in Surrey
Salary
Competitive hourly rate of pay
Posted
01 Apr 2021
Closes
01 May 2021
Ref
0203GMPQA
Hours
Full Time
Contract Type
Contract
Experience Level
Management

DETAILS:

  • Full-time contract position
  • ASAP start for minimum 12 month contract
  • Remote UK working with 40% UK and EU travel post restrictions
  • Competitive hourly rate of pay
  • Global pharma company

THE ROLE:

The GMP Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GMP portfolio/programs/entities. This role is responsible for GMP Oversight and for assuring the compliance of projects, products and programs with Client Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations, guidelines and standards (e.g., US FDA, EU Directives, National regulations, ICH, ISO)..

• Independently plans/leads/conducts wide range of (non-routine) complex audits including commercial/clinical manufacturing sites and contract manufacturers and performs complex process audits with oversight.
• Executes audit strategy, leads process audits and performs special assessments
• Acts as a reviewer of audit reports from outsourced or routine audits
• Assesses audit plans and quality metrics to identify potential areas of risk
• Actively supports regulatory inspections as needed

Full job description available on application

THE CANDIDATE:

• BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent
• Demonstrates advanced knowledge in ICH and global regulations (e.g., FDA, EMA, HC, ANVISA, TGA) and international standards (e.g., ISO, WHO)
• Acts as a specialist in complex technologies (e.g., sterile injectables, low bioburden, biotech, MDCP); Can perform special assessments and participate on process audit teams
• Has 5+ years of experience (2 levels; operations and auditing required)
• Lead audit teams (2-6 ppl per team)

The travel requirement may be approx. 40%

  • Only candidates with existing right to work in the UK/EU will be considered

TO APPLY:

Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email alex@apexrecruitment.com

To view our other vacancies, please visit our website on www.apexrecruitment.com

Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.

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