DI & Remediation
Copilot said:
Location: Southern France (exact site location to be discussed)
Contract: 3-6 months (extension potential)
Working Pattern: Primarily onsite
Languages: Fluent French required
Overview
We are currently seeking experienced GMP Data Integrity & Remediation Consultants to support a major pharmaceutical manufacturing programme focused on improving compliance, remediating legacy systems and strengthening data integrity controls across regulated environments. This is a hands-on role requiring consultants who can execute remediation activities, implement corrective actions, support system improvements and deliver inspection-ready documentation within GMP-regulated operations.
Key Responsibilities
* Execute data integrity remediation activities across manufacturing, laboratory and business systems.
* Support the review and improvement of user access management, audit trails, electronic records and system controls.
* Implement corrective and preventive actions associated with data integrity findings and compliance gaps.
* Support investigations, deviations, CAPAs and risk assessments related to computerized systems.
* Perform audit trail testing, security testing, access reviews and verification activities.
* Develop and revise procedures, work instructions and compliance documentation.
* Support system upgrades and remediation activities designed to address data integrity deficiencies.
* Work closely with Quality, IT, Validation, Manufacturing, QC and system owners.
* Produce complete, compliant and inspection-ready documentation to support remediation activities.
Preferred Experience
* Experience within pharmaceutical, biotechnology, vaccine, sterile manufacturing or other GMP-regulated environments.
* Strong knowledge of Data Integrity principles including ALCOA+.
* Experience with EU GMP Annex 11, 21 CFR Part 11 and electronic records compliance requirements.
* Hands-on experience supporting remediation programmes, audit trail reviews, access management and system security improvements.
* Experience investigating and resolving compliance gaps within GMP computerized systems.
* Strong understanding of change control, deviation management, CAPA processes and computerized system lifecycle requirements.
* Recent hands-on remediation, testing, verification and implementation experience.
* Ability to work directly with cross-functional teams to drive practical and sustainable compliance improvements.