JOB DESCRIPTION
Contract Type
Candidate (Freelancer)
Company Type
CRO / CDMO
Company Size
Small 100 – 1000
Requested Expertise
Quality / Clinical study / Clinical development /
Profile Required
– Key infos –
PharmD or scientific background with strong GCLP experience (or GLP + clinical trial experience).
Senior profile.
English fluent, French is a plus.
Available from September to December 2025 for 5 to 10 audit in Europe (1 week each).
More infos on what can be expected:
▪ Bachelor of Science degree in life or natural science
▪ Minimum of five-eight (5-8) years of experience in Clinical Laboratory operations or clinical research focusing on GCLP
▪ Minimum 5 years of experience in Quality Assurance, GCLP Audit
▪ In-depth knowledge of drug development process, compliance regulations
(domestic and international), GCLP regulations, Good Laboratory Practice (GLP) and ISO 15189 – FDA, EMEA and ICH guidelines
▪ Experience in regulatory authority inspection
▪ Strong understanding of clinical laboratory processes and QMS
▪ Excellent auditing, analytical, and problem-solving skills
▪ Strong attention to detail and ability to assess complex compliance issues
▪ Effective communication skills
▪ Good organizational skills, interpersonal and communication skills
▪ Good computer skills – MS office, Internet
▪ A good knowledge of English in addition to local language(s)
▪ This role may require coverage beyond normal working hours.
Project Description
– Key infos –
Client is an international CRO working for international organizations.
Looking for a EU GCLP Audit specialist to perform 5 to 10 audit (5 days each : 1 day prep, 2 days on site, 2 days post audit) on Q3 / Q4 2025 in whole Europe.
More infos on what can be expected :
– Position summary –
Laboratory Services GCLP Specialist is responsible is responsible for monitoring the GCLP.
Accreditation Schedule to ensure that all audits are scheduled and conducted prior to their certificate expiry dates.
Ensuring GCLP Audit are conducted to relevant regulations and Procedures.
– Principal Accountabilities –
Departmental activities
o Manage the GCLP accreditation scheme according to the corresponding
SOP
o Schedule external GCLP Audits of Clinical Laboratories
o Write and execute the detailed GCLP audit Plan
o Conduct GCLP audit ensuring compliance with GCLP and GLP regulations
(FDA, EMA, ICH), and procedures
o Assess Laboratory activities, documentation and processes to identify area
of non compliance, risks or inefficiencies
o Write detailed audit report summarizing each observations
o Review and follow up all proposed Corrective Action and Preventive Action
(CAPA) indicated by Laboratory
o Issue the final GCLP audit report and the accreditation certificate
o Monitors and communicates standards created by regulatory bodies, and
integrate within internal Quality Management systems
o Advise of Management of any deficiencies in regulatory requirements
o Act as a subject matter expert on GCLP-related issues and provide expert
QM advice to employees concerning the GCLP activities in accordance with
applicable procedural documents, regulatory requirements and guidelines.
o Monitors and communicates standards created by regulatory bodies, and
integrate within internal Quality Management systems
o Provide support to Quality Management team on any activities handled by
QM department
o Identifying opportunities for improving compliance processes and
procedures.
o Works closely and cross functionally with other departments involved in
risk management, compliance and business continuity
o Develops and provide training on topics of interest
o Contribute in the development of the QM departmental and corporate
controlled document (SOPs, Working Practice and Polices)
o Provide expert QM advice to employees concerning the conduct of clinical
trial and GCLP activities in accordance with applicable procedural
documents, regulatory requirements and guidelines.
o Perform administrative tasks as required;
▪ Travel commitment:
As an international organisation operating globally, staff agrees to travel
according to their roles and responsibilities in the organisation. As an indication, an average of two (2) business trips per month is anticipated.
Therapeutic Area
All
Language
English
Hard Skills
Soft Skills
Seniority Level
Experience > 10 years
Starting Date
2025-09-01
Project Duration
25 to 50 days (5 days per audit)
FTE / nb of days per week
2
Project Location
Europe, United Kingdom
Remote Flexibility
Yes
Travel Expected
Yes
Approximative Budget
Any other information of interest
or recommend someone & get 1000€ from pharmatch.co !
contact@pharmatch.co