Manager - Quality Control

GUFIC BIOSCIENCES LIMITED; Indore District; On-site; INR 700,000 - 1,100,000; Full time

Job summary

GUFIC BIOSCIENCES LIMITED in Indore seeks a results-driven Overall QC Laboratory Manager to lead routine QC activities across chemical, instrumental, microbiology, sterility testing, endotoxin monitoring, and environmental controls. You will plan testing of raw materials, APIs, excipients, packaging components, in-process samples, finished products, and stability samples, ensuring timely reporting.

The role covers data review, method validation and instrument qualification, GDP compliance, CAPA,

Responsibilities

• 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.

Job description

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 Good 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.

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