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.

- 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.

- 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.

- 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.

- 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.

- 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.

- 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.

- 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.

- 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.

- 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

- Solid 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.

📌 Walk-in || Quality Control(Reviewer) (Balanagar)
🏢 JanSat Labs
📍 Balanagar