Auditor. GCP (Good Clinical Practice) + GxPs (CSV / GLP). EMEA

Recruiter
Morgan Prestwich Recruitment Limited
Location
North London
Salary
£58k - £70k
Posted
29 Nov 2016
Job Sector
Care & Social Work
Contract Type
Permanent
Hours
Full Time
Auditor. GCP (Good Clinical Practice) + GxPs (CSV / GLP). EMEA

· UK / Europe - Home Based Position

· Travel: Across Europe - Auditing

· Solo/Lead GCP (Good Clinical Practice) + GxPs Auditor required

· Additional GxPs Preferred - CSV (Computer System Validation) and GLP

· 4+ Years GCP Lead/Solo Auditing experience required - Clinical Investigator Sites and Vendors in Europe

· Solid working knowledge and understanding of all European regulations

Seeking an experienced clinical research GCP (Good Clinical Practice) auditor with additional GxPs auditing experience, Preferably - CSV (Computer System Validation) or GLP (Good Laboratory Practice)

You will be an established European solo clinical investigator site auditor with a high level experience and knowledge of European/EMEA regulatory requirements and industry guidelines governing global GCP.

You will be living in the UK or Europe, with good local access to a main European connecting airport. Fluent spoken and written English to a high level will be imperative, and additional languages beneficial, although not essential - Other than local country language and English.

Overview:

My client is a leading full service GxP QA Specialist organisation, with true global reach, and a growing team of successful QA auditing professionals working across GxP auditing specialisms with multiple industry leading clients, vendors / CRO's.

As part of their continued EU/EMEA audit team growth, they seek an experienced GCP (Good Clinical Practice) Investigator Site Auditor to work fully remote - home based in Europe.

You will undertake a range of rewarding and challenging solo GCP audits for multiple Clients and Vendors, including Investigator Sites / CRO's and Laboratories involved in Clinical Research.

Additionally, you may also undertake additional GxP audits - Preference for additional CSV or GLP auditing experience. You should have experience in at least one other GxP in addition to your main auditing experience for GCP (Good Clinical Practice).

Requirements:

You will already be an experienced solo/lead GCP (Good Clinical Practice) Auditor, with proven solo auditing experience across Europe and possibly International, auditing multiple GCP Investigator sites/ CRO's and Vendors for at least 4 years to date - Within industry employment direct, and preferably additional consulting work.

· You will have a proven background within QA of at least 5+ years to date and will be able to demonstrate the abilities required to work independently and to manage your travel and audit follow up responsibilities from a home office set up.

· You will demonstrate the skills required to work effectively and smart to meet deadlines and clients time criteria's, and to always demonstrate a professional outlook to uphold the high standards and reputation of the client.

· Auditing experience ideally to include 4+ years continuous work within industry direct (And/Or) additional consulting work to industry with at least 3+ years in industry direct. You will be able to clearly demonstrate your experience working as a solo/lead GCP (Good Clinical Practice) Investigator and vendor site auditor - for at least 3+ years.

· Additional GxPs auditing experience - (CSV, GLP)

Additional Skills / Knowledge Required:

· You will be fully experienced in writing full and detailed audit reports, and will be expected to complete these for each vendor/client site audit undertaken.

· You will clearly demonstrate a strong work ethic to managing daily tasks and working to tight timelines, ensuring each individual client/vendor audit project is completed to the same exemplary high levels and standards every time

Travel Requirements:

* You will be available and eligible to travel across Europe as required, without travel restrictions and be available to travel circa 40-50% of the working time.

* If you are a dynamic, motivated and driven Quality Assurance GCP Auditing professional, seeking more scope to work independently, home based, with a real consulting feel and a guaranteed employed income together with full benefits - This may be the ideal GCP auditing opportunity for you.

Our client has a broad portfolio of clients across the Europe / EMEA, United States, South America, Canada, and APAC. You will be working across a continual broad range of GCP auditing projects.

* Solid knowledge of international regulatory requirements desired + Industry guidelines governing GCP (Good Clinical Practice), GMP, GLP - ICH, EMA, MHRA and local European regulations

* Ability to assimilate and analyse information rapidly

* Life Science Degree minimum. BSc / MSc. PharmD, PhD

* Current resident and working in Europe

* Home Based. With eligibility to travel as required without travel restrictions

* Registrations, accreditations or certifications - Preferred

Package:

Our client offers a competitive base salary, generous start holiday allowance and associated benefits, plus the scope to develop their career, together with an exciting portfolio of clients across Pharma, Biotech and CRO's.

Apply today and forward your CV for consideration