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 Valuable 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.

Email

- [email protected]

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