Manager - Quality Control

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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