Manager - Quality Assurance

A. Quality Management System (QMS)

• Implement, maintain, and continuously improve the pharmaceutical Quality Management System in accordance with applicable GMP requirements.
• Ensure implementation and periodic review of SOPs, specifications, protocols, quality policies, and other controlled documents.
• Manage deviations, non-conformances, investigations, CAPA, change control, risk assessments, and effectiveness checks.
• Monitor recurring deviations, quality trends, and systemic issues and drive continuous improvement.
• Ensure implementation of Good Documentation Practices (GDP), data integrity principles, and ALCOA+ requirements.
• Coordinate periodic management reviews and preparation of quality performance reports.
• Ensure timely escalation of critical quality issues to the Site Quality Head and senior management.

B. Sterility Assurance and Contamination Control

• Ensure effective implementation of the site's contamination control strategy (CCS), aligned with applicable GMP requirements, including EU GMP Annex 1 where relevant.
• Oversee QA monitoring of aseptic processing, sterile filtration, filling, sealing, and other critical manufacturing operations.
• Ensure appropriate controls for classified areas, personnel practices, material and personnel movement, and contamination prevention.
• Review environmental monitoring trends, personnel monitoring results, cleanroom excursions, and microbiological investigation reports.
• Ensure appropriate investigation and assessment of microbial contamination, sterility failures, endotoxin excursions, and other potential sterility assurance risks.
• Review and approve contamination-related risk assessments and CAPA within delegated authority.
• Ensure that critical sterility assurance concerns are assessed for potential impact on affected batches and other products or operations.
• Coordinate with QC Microbiology, Production, Engineering, and Validation to maintain the microbiological and environmental control state.

C. Aseptic Process and Sterile Manufacturing Oversight

• Provide QA oversight during aseptic filling, sterile filtration, solution preparation, component preparation, and other critical manufacturing activities.
• Ensure compliance with approved batch manufacturing records, aseptic practices, line clearance requirements, and in-process controls.
• Review critical process parameters and critical quality attributes as defined in approved procedures.
• Ensure appropriate QA oversight of aseptic process simulations (media fills), including protocol review, execution oversight, result evaluation, and investigations.
• Review interventions, stoppages, line events, environmental excursions, and other atypical events during aseptic operations.
• Ensure qualification and monitoring of personnel involved in aseptic processing, including gowning qualification and periodic requalification.
• Oversee implementation of applicable controls for sterilization, depyrogenation, sterile filtration, and container-closure integrity.
• Ensure that any proposed intervention or process change is assessed for potential impact on sterility assurance and product quality.

D. Batch Record Review and Batch Disposition

• Review and ensure timely completion of batch manufacturing records (BMRs), batch packaging records (BPRs), and associated quality documentation.
• Verify compliance with approved manufacturing instructions, specifications, in-process controls, yield reconciliation, line clearance, and deviation handling.
• Review QC analytical results, microbiological results, environmental monitoring data, and other relevant quality information before recommending batch disposition.
• Ensure all critical deviations, OOS results, process excursions, and other quality events are appropriately investigated and resolved or formally assessed before disposition.
• Coordinate batch release activities with QC, Production, Warehouse, and other relevant departments.
• Ensure that batch release or rejection decisions are made only by appropriately authorized personnel under the site's quality system and applicable regulations.
• Ensure that rejected, quarantined, and released materials and products are clearly identified and appropriately controlled.

E. Deviation, OOS, CAPA, and Change Control

• Lead or oversee investigations related to manufacturing deviations, process failures, contamination events, documentation errors, complaints, and other quality incidents.
• Ensure that root-cause investigations are scientifically justified and supported by documented evidence.
• Review OOS and OOT investigations in coordination with QC and other relevant departments.
• Assess the potential impact of deviations on product quality, patient safety, validated status, and regulatory compliance.
• Approve or recommend CAPA and change controls within the assigned authority.
• Monitor CAPA implementation, effectiveness, closure timelines, and recurrence of similar events.
• Ensure changes affecting sterile processes, facilities, utilities, equipment, cleaning, sterilization, or analytical methods undergo appropriate quality and regulatory impact assessment.

F. Validation and Qualification

• Oversee QA review and approval of validation and qualification protocols and reports.
• Ensure appropriate qualification of facilities, cleanrooms, HVAC systems, equipment, utilities, and critical manufacturing systems.
• Review and oversee process validation, aseptic process simulation, cleaning validation, sterilization validation, depyrogenation validation, sterile filtration validation, and other applicable validation activities.
• Ensure periodic review and maintenance of the validated state.
• Review qualification and validation deviations and ensure appropriate investigation and CAPA.
• Coordinate with Engineering, Production, QC, and Validation teams to ensure validation activities comply with approved protocols and applicable regulatory requirements.

G. Documentation Control and Data Integrity

• Ensure effective document lifecycle management, including preparation, review, approval, issuance, revision, retrieval, and archival of controlled documents.
• Ensure compliance with Good Documentation Practices and applicable electronic records requirements.
• Oversee management of data integrity risks involving paper-based and computerized systems.
• Ensure appropriate access controls, audit trail review, backup, and record retention for relevant computerized systems.
• Investigate documentation discrepancies, unauthorized changes, missing records, and potential data integrity violations.
• Ensure training and awareness of employees on documentation requirements and data integrity principles.

H. Regulatory Inspections and Customer Audits

• Plan and coordinate regulatory inspections, customer audits, corporate audits, and internal GMP audits.
• Ensure continuous inspection readiness of manufacturing areas, quality systems, utilities, documentation, and validation records.
• Coordinate audit responses, corrective actions, and commitments with relevant departments.
• Track observations and ensure timely implementation and verification of CAPA.
• Support inspections by CDSCO and applicable state authorities, as well as US FDA, EU authorities, WHO, or other agencies relevant to the site's markets.
• Ensure that inspection responses are evidence-based, scientifically justified, and consistent with regulatory commitments.

I. Training and Personnel Qualification

• Establish and monitor GMP training programmes for employees across relevant departments.
• Ensure personnel are trained and qualified before performing assigned GMP activities.
• Oversee training on aseptic behaviour, gowning, contamination control, data integrity, SOPs, deviation reporting, and applicable safety requirements.
• Ensure periodic assessment and requalification of personnel involved in critical aseptic operations.
• Monitor training effectiveness and identify recurring training gaps.
• Develop QA team capabilities through coaching, competency assessment, and performance reviews.

J. Product Complaints, Market Actions, and Recall Support

• Coordinate investigations of product complaints, including visible particles, leakage, container defects, labelling issues, and suspected contamination.
• Ensure timely assessment of complaints in coordination with QC, Production, Regulatory Affairs, and other relevant departments.
• Evaluate potential impact on other batches, products, or manufacturing processes.
• Support product recall, field alert, and regulatory notification activities where required.
• Ensure complaint trends are reviewed and appropriate CAPA is implemented.
• Maintain appropriate traceability and documentation for quality-related market actions.

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