Manager - Quality Assurance

GUFIC BIOSCIENCES LIMITED; Indore District; On-site; INR 1,000,000 - 1,800,000; Full time

Job summary

GUFIC BIOSCIENCES LIMITED is seeking a QA/QMS leader to implement and maintain the pharmaceutical quality management system in Indore. You will oversee aseptic operations, documentation control, investigations, CAPA, and batch release processes to ensure regulatory compliance and product quality.

The role requires strong GMP knowledge, data integrity focus, and collaboration across QA, Production, QC, and Validation teams in a fast-paced manufacturing environment.

Responsibilities

• Implement, maintain, and improve the pharmaceutical QMS per GMP.
• Review SOPs, specs, protocols and other controlled documents.
• Manage deviations, non-conformances, investigations, CAPA, change control and risk assessments.
• Monitor quality trends and drive continuous improvement.
• Uphold GDP, data integrity principles and ALCOA+ requirements.
• Coordinate management reviews and quality performance reports.
• Escalate critical quality issues to Site Quality Head and senior management.
• Oversee contamination control strategies and QA monitoring of aseptic operations.
• Review environmental monitoring trends and microbiological data.
• Ensure QA oversight of aseptic processes, validation, and line clearance.
• Coordinate batch release and ensure proper disposition by authorized personnel.
• Lead investigations into deviations, OOS, CAPA, and change control with regulatory impact.

Job description

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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