Overall QC Laboratory Management

- Manage routine QC activities covering chemical analysis, instrumental analysis, microbiology, sterility testing, bacterial endotoxins testing, environmental monitoring, and other applicable laboratory functions.

- Plan and monitor testing of raw materials, active pharmaceutical ingredients (APIs), excipients, primary packaging components, in-process samples, finished products, and stability samples.

- Ensure timely testing and reporting in accordance with approved specifications, analytical methods, pharmacopoeial standards, and internal procedures.

- Review analytical data, calculations, chromatograms, laboratory worksheets, test reports, and certificates of analysis.

- Ensure adequate availability of trained personnel, laboratory equipment, reference standards, reagents, media, and consumables.

- Monitor laboratory performance, testing turnaround time, pending samples, workload, and resource utilization.

Chemical and Instrumental Analysis

- Ensure analysis of injectable products using validated or otherwise appropriately qualified analytical procedures, as applicable.

- Supervise testing for identification, assay, related substances, degradation products, pH, clarity, colour, particulate matter, fill volume, extractable volume, and other product-specific parameters.

- Ensure performance of applicable visible and sub-visible particulate matter testing according to approved methods and pharmacopoeial requirements.

- Ensure appropriate testing of APIs, excipients, container-closure components, and other materials used in sterile product manufacturing.

- Ensure proper operation, calibration, qualification, maintenance, and troubleshooting of HPLC, GC, UV-Visible spectrophotometers, FTIR, TOC analysers, conductivity meters, pH meters, particle counters, and other relevant instruments.

- Review chromatograms, integration parameters, system suitability, calculations, audit trails, and analytical data for accuracy and compliance.

OOS, OOT, Deviations, and CAPA

- Lead and coordinate investigations related to Out-of-Specification (OOS), Out-of-Trend (OOT), atypical results, analytical errors, sterility failures, endotoxin excursions,



environmental monitoring excursions, and water system failures.

- Ensure scientifically sound investigations, documented root-cause analysis, impact assessment, and effective CAPA.

- Ensure that retesting, resampling, and invalidation of results are performed only when scientifically justified and authorized under approved procedures.

- Assess potential impact on affected batches, related batches, utilities, and products already distributed, in coordination with QA.

- Monitor investigation timelines, recurring deviations, and CAPA effectiveness.

Stability Studies

- Plan and monitor stability studies for injectable products according to approved protocols and applicable regulatory requirements.

- Ensure timely withdrawal, testing, review, and reporting of stability samples.

- Review stability trends for assay, degradation products, pH, particulate matter, sterility-related attributes where specified, container-closure integrity-related parameters where applicable, and other product-specific tests.

- Coordinate investigation and escalation of stability failures or adverse trends.

- Ensure stability chambers are qualified, monitored, calibrated, and maintained, with documented management of temperature and humidity excursions.

Analytical Method Validation and Instrument Qualification

- Oversee analytical method validation, verification, transfer, and periodic review as applicable.

- Review protocols and reports for analytical method validation, cleaning-related analytical methods where applicable, and method transfer.

- Ensure qualification, calibration, maintenance, and performance verification of laboratory equipment.

- Ensure compliance with applicable requirements for computerized systems, audit trails, access controls, data backup, and electronic records.





- Coordinate with QA, Engineering, IT, and external service providers for laboratory instrument qualification and system compliance.

Data Integrity and Documentation

- Ensure compliance with Positive Documentation Practices (GDP), data integrity requirements, and ALCOA+ principles.

- Review raw data, chromatograms, audit trails, worksheets, calculations, logbooks, and laboratory reports for completeness, accuracy, traceability, and contemporaneous recording.

- Ensure controlled issuance, review, approval, and periodic revision of QC SOPs, specifications, analytical methods, protocols, and reports.

- Ensure proper management of reference standards, working standards, reagents, volumetric solutions, microbiological media, and laboratory records.

- Investigate data discrepancies, unauthorized data changes, incomplete records, and potential data integrity concerns.

Regulatory Audits and Inspections

- Lead QC preparation for regulatory inspections, customer audits, and internal audits.

- Represent QC during inspections by applicable regulatory authorities, including US FDA, CDSCO, and other authorities relevant to the facility's markets.

- Provide accurate and traceable documentation in response to inspection requests.

- Coordinate responses to QC-related observations and ensure timely implementation and verification of CAPA.

- Maintain inspection readiness across chemical, instrumental, microbiological, sterility testing, and utility monitoring laboratories.

Team Leadership and Training

- Lead QC chemists, microbiologists, analysts, and laboratory support personnel.

- Prepare manpower plans, work schedules, training plans, and competency assessments.

- Ensure personnel are qualified before independently performing critical testing activities.

- Provide training on aseptic processing-related microbiological controls, analytical techniques, GMP, data integrity, laboratory safety, and investigation procedures, as applicable.

- Conduct performance reviews and develop technical and leadership capabilities within the QC team.

Email Id : [email protected]

📌 Manager - Quality Control (Indore)
🏢 Gufic Biosciences
📍 Indore