Back to Job SearchROLE OVERVIEW
We are currently looking for a Data Integrity Consultant to join a leading organisation in the pharmaceutical industry, based at their site. This is an exciting opportunity for a professional with proven experience in GMP QC laboratory environments to support critical retrospective Data Integrity reviews following a recent assessment.
As a Data Integrity Consultant, you will play a key role in ensuring the accuracy and compliance of laboratory data, helping to maintain the highest standards of GMP and data integrity across the organisation.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Data Integrity Consultant will be varied; however, the key duties and responsibilities are as follows:
• Review historical laboratory records and data as part of retrospective Data Integrity assessments.
• Support review of unexplained trial injections, especially related to HPLC / chromatography data.
• Assess completeness, accuracy, and compliance of laboratory records, focusing on GDP documentation issues.
• Support retrospective review of OOS investigations to confirm appropriate investigation, root cause, impact assessment, and closure.
• As the Data Integrity Consultant you will ensure documentation is accurate, compliant, and aligns with regulatory standards.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Data Integrity Consultant, we are looking to identify the following on your profile and past history:
• A Degree or higher level in a scientific discipline.
• Proven industry experience in GMP QC laboratory environments.
• A working knowledge and practical experience with Data Integrity, ALCOA+ / ALCOA++, and laboratory documentation review.
WHAT’S IN IT FOR YOU?
This role offers an excellent opportunity to contribute to high standards within the pharmaceutical industry, in a reputable organisation committed to compliance and quality. You will gain valuable experience in Data Integrity and GMP practices, with the chance to influence critical quality processes.
Key Words: Data Integrity / GMP QC laboratory / retrospective review / HPLC / chromatography / GDP documentation / OOS investigations / CAPA / remediation / Albuquerque / pharmaceutical industry
"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career."
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
