Reviewer

Job Description:

The QC Reviewer is responsible for reviewing and approving electronic analytical data and analytical batch records to ensure compliance with Current Good Manufacturing Practices, Data Integrity Principles, and Regulatory Requirements. This role involves audit trail review, analytical record verification, and metadata assessment, ensuring data accuracy, completeness, and integrity. Additionally, the QC Reviewer acts as the Data Integrity Champion within the QC laboratory, supporting training, governance, and compliance enhancement activities.

Key Responsibilities:

Review and approve electronically generated analytical data, analytical batch records, test results, and calculations for accuracy, completeness, and compliance with specifications.
Ensure adherence to cGMP, laboratory SOPs, regulatory standards, and pharmacopeial requirements, and drive improvements in analytical data management.
Perform audit trail review for analytical instruments and software systems, identifying and addressing anomalies.
Identify and resolve discrepancies in analytical data, and verify instrument performance, method execution, and calculation accuracy before batch disposition.
Ensure all data is traceable, attributable, and tamper-proof, following ALCOA++ principles.
Ensure user access control compliance, preventing unauthorized data modifications.
Collaborate with IT and QA to ensure electronic data systems are validated and compliant with 21 CFR Part 11, EU Annex 11, and WHO TRS 996 Annex 4.
Act as the QC Data Integrity Champion, ensuring DI best practices are consistently followed.
Support DI investigations, CAPA implementation, and corrective measures for non-compliance.
Ensure all QC staff are aware of Good Documentation Practices (GDP) and electronic data management policies.
Lead DI investigations in QC, ensuring proper root cause analysis and CAPA implementation.
Identify risks related to electronic and paper-based data handling, proposing effective mitigation strategies.
Develop and conduct training sessions on data integrity and electronic record compliance for QC personnel.
Monitor DI deviations trends and provide required information for Periodic Management Review.
Contribute to the revision and implementation of QC system SOPs.

Your Profile:

Bachelor s or master s degree in Pharmaceutical Sciences, Chemistry, or a related field.
Minimum 7 years of experience in a pharmaceutical QC laboratory, with expertise in analytical data review and data integrity compliance.
In-depth knowledge of GMP, GLP, Data Integrity Guidelines (MHRA, FDA, WHO, EU), and computerized system validation.
Hands-on experience with analytical instruments and software (e.g., Empower, Labsolution, LIMS, OpenLab).
Strong understanding of audit trails, metadata analysis, and electronic data governance.

Key Competencies & Skills:

Expertise in analytical batch record review and approval.
Strong data integrity awareness and compliance mindset.
Ability to identify data anomalies, audit trail inconsistencies, and documentation errors.
Excellent problem-solving and analytical skills.
Effective communication and training skills, capable of leading DI initiatives.