Quality Control(Reviewer)

Role & responsibilities

Key Roles & Responsibilities

1. Analytical Data Review

• Review raw data, chromatograms, spectra, worksheets, and analytical results.
• Verify accuracy, completeness, and traceability of laboratory data.
• Review HPLC, GC, LC-MS/MS and other analytical data, where applicable.
• Verify calculations, dilutions, standard preparations, and result reporting.

2. Laboratory Documentation Review

• Review analytical test reports, worksheets, notebooks, logbooks, and instrument records.
• Ensure all entries are complete, legible, contemporaneous, and properly documented.
• Verify adherence to approved SOPs, specifications, and analytical methods.

3. Chromatographic Data Review

• Review chromatograms for:

• Peak integration

• System suitability

• Retention time

• Resolution

• Tailing factor

• Theoretical plates

• %RSD

• Blank and placebo interference

• Identify abnormal trends, atypical results, and potential data integrity concerns.

4. OOS / OOT Review

• Support the review and investigation of Out-of-Specification (OOS) and Out-of-Trend (OOT) results.
• Check laboratory investigation records and supporting analytical data.
• Ensure investigations are properly documented and scientifically justified.

5. Data Integrity

• Ensure compliance with ALCOA+ principles.
• Review audit trails, electronic records, and system-generated data where applicable.
• Identify discrepancies, unauthorized changes, missing data, or unusual laboratory practices.

6. Instrument & System Review

• Verify instrument usage, calibration, qualification, maintenance, and suitability.
• Review sequence details, method parameters, processing methods, and system suitability results.
• Ensure analytical instruments are used according to approved procedures.

7. Method & Specification Compliance

• Verify testing against approved analytical methods and specifications.
• Ensure current versions of methods, SOPs, specifications, and protocols are being followed.
• Identify deviations from approved procedures.

8. Deviation & CAPA Support

• Review QC-related deviations and provide technical input.
• Support root-cause analysis and CAPA implementation.
• Ensure corrective and preventive actions are adequately documented.

9. Certificate of Analysis (COA) Review

• Review analytical results before final approval of COA.
• Verify results against approved specifications.
• Ensure correct calculations, units, limits, and reported results.

10. Regulatory & GMP Compliance

• Ensure laboratory activities comply with applicable GMP and regulatory requirements.
• Support internal, customer, and regulatory inspections/audits.
• Provide required QC documentation and explanations during audits.

Essential Skills

• Strong knowledge of GMP/GLP and data integrity
• HPLC, GC, LC-MS/MS and other analytical techniques
• Chromatographic data interpretation
• OOS/OOT investigation
• Deviation and CAPA management
• Analytical method and specification review
• Excellent documentation and attention to detail
• Knowledge of electronic laboratory systems/CDS and audit-trail review
• Good communication and technical writing skills

Preferred candidate profile

• Qualification: M.Sc. / M.Pharm / B.Pharm / M.Tech in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, or a relevant discipline.
• Experience: 15 years of experience in QC, analytical testing, or QC data review within the pharmaceutical industry.
• Hands-on or strong review experience with HPLC, GC, LC-MS/MS, and other analytical techniques.
• Good knowledge of GMP, GLP, GDP, and ALCOA+ data integrity principles.
• Experience in reviewing chromatographic data, analytical worksheets, calculations, specifications, methods, and COAs.
• Knowledge of OOS, OOT, deviations, CAPA, laboratory investigations, and audit-trail review.
• Strong understanding of analytical method validation/verification and system suitability requirements.
• Good attention to detail with the ability to identify data discrepancies, calculation errors, documentation gaps, and compliance issues.
• Good communication, documentation, and analytical problem-solving skills.
• Ability to work independently and coordinate effectively with QC, QA, and other laboratory teams.
• Candidates with exposure to regulated pharmaceutical environments and regulatory inspections will be preferred.