Senior GMP QA Auditor

Location: Harrogate, North Yorkshire
Company: LabCorp
Industry: IT
Job Type: Permanent
Posted: Yesterday

Are you a skilled and experienced GMP Auditor looking for a new role offering career development?

Do you want to join a company that understands flexible and remote working?

Are you committed to supporting process improvement and change?

Labcorp is a leading global life sciences company. With a mission to improve health and improve lives, Labcorp delivers world-class diagnostic solutions, brings innovative medicines to patients faster and uses technology to improve the delivery of care.

We are recruiting for our BioPharmaceutical CMC Chemistry team covering both the Harrogate & York facilities and are currently seeking to hire a QA GMP Auditor to support the team.

This is a full time position, to be based in our Harrogate office. It should be noted that neither the Harrogate or York facilities hold a manufacturing licence and that the nature of the GMP work undertaken is limited to outsourced QC analysis and product stability testing.

Duties include:

  • Performing regulatory review of study related documentation (ie batch records, protocols, methods, reports, certificates of analysis, etc.) to ensure compliance with GMP, LabCorp document management procedures, Client requirements and other applicable quality standards

  • Reviewing and approving of deviation investigations and associated CAPA (addressing the cause and resolution of quality defects)

  • Supporting the GMP QA internal audit programme by participating in audits of GMP-related systems, processes and facilities

  • Reviewing metrology methods and specifications for accuracy/relevance and compliance with appropriate quality standards

  • Supporting root cause investigations/risk assessments

  • Contributing to continual improvement initiatives aimed at improving the efficiency/effectiveness of GMP operations

What Labcorp can offer you:

  • Competitive salaries and a comprehensive benefits package including health cover and contributory pension

  • Flexible and remote working

  • Unrivalled opportunities to develop a successful career in the scientific industry, including management training and senior apprenticeships

  • Unsurpassed career development opportunities and the chance to progress quickly up the career development framework

  • Relocation package subject to criteria

What we're looking for :

To be successful in this position, you should ideally hold a Bachelor's Degree in a Chemistry or Biology related discipline

Additionally, you will need to demonstrate:

  • Experience of analytical work within a GMP laboratory environment (or an equivalent level of experience in a non-GMP quality role within the Pharmaceutical Industry)

  • Good verbal and written communication in English

  • In depth knowledge of Good Manufacturing Practice Regulations

  • General awareness of industry quality systems/standards, eg ICHQ10

  • Decision making, negotiating, and problem solving skills

  • Ability to work under minimal supervision

  • Computer literate

  • Experience in process improvement preferable

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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Web Reference : AJF/373135802-19
Posted Date : Wed, 17 Aug 2022

To apply for this position you will complete an application form on another website provided by or on behalf of LabCorp. Please note Entire Jobs is not responsible for the application process on any external website.