Head Quality Assurance (Pharma) - Paithan ( Aurangabad )

Lead and manage all aspects of Quality Assurance to ensure compliance with regulatory standards

(Schedule M, WHO TRS, USFDA, MHRA), maintain product and process quality, and promote a

culture of continual improvement across the organization through the CIP SOP.

-Ensure compliance with GMP, GLP, ALCOA++, and regulatory requirements

(Schedule M, WHO TRS, USFDA, MHRA)

- Manage Quality Management Systems (eQMS), including CAPA, deviations, and

audits, leveraging analytics for trend analysis.

- Oversee batch review and release/rejection processes in SAP to ensure timely

product approvals.

- Coordinate with customers for technical queries and timely closures.

- Conduct root cause investigations for non-conformances and establish CAPA.

- Monitor and manage stability programs for all products and ensure real-time release

testing (RTRT) when applicable.

- Ensure effective implementation of change control management systems.

- Liaise with regulatory agencies and always ensure audit readiness.

- Oversee Quality Control functions, including analytical testing, stability studies, and

release activities.

QA to access all major production process changes for quality impact and batch

release implications before implementation.

- Monitor GMP compliance in all areas of manufacturing and engineering.

- Maintain systems for SOP and batch record control, ensuring timely issuance.

- Track and ensure compliance with pharmacopeial changes within 30 days of

updates.

- Contribute to cost reduction and efficiency initiatives aligned with plant-wide goals.

- Develop and mentor QA/QC teams to build a culture of quality and compliance.

- Conduct training sessions on cGMP, GLP, and QMS for employees, ensuring 100%

completion of training programs.

- Identify and address training needs of employees for skill enhancement.

- Oversee vendor qualification, audits, and performance monitoring using scorecards.

- Conduct internal audits and ensure timely closure of findings.

- Coach employees on quality processes and encourage adherence to ALCOA++

principles.

- Implement strategies to avoid repeat deviations, OOS, and market complaints.

- Approve all the Quality Documents, SOP, Protocols, Report, Change Control,

Deviation invistigation, Market Complaint, OOS, OOT,APQR, CAPA, VMP, SMF, Audit

Compliance reports

- Monitor inventory and consumption of consumables, ensuring cost control.

- Lead initiatives to implement eQMS for digital transformation, integrating

SAP/MEPs for seamless operations.

-Drive continual improvement initiatives across QA/QC/Production/Engineering/HR/IT

functions.

- Collaborate with R&D to support product launches, process validations, and

analytical transfers.

- Ensure quality compliance for new projects, facility upgrades, and regulatory

inspections.

Reduce analytical testing waste by 10% per year through method, Optimisation &

sustainability focused reagent management.

- Develop quality assurance improvement plans by conducting risk analyses.

- Represent the organization during regulatory and customer audits.

- Ensure customer satisfaction through effective complaint handling and

communication.

- Plan and execute quality-related training programs with HR for site-wide

compliance.

- Manage and improve the Product Quality Review (PQR) process and APQR reports.

- Lead the adoption of real-time release testing (RTRT) and advanced analytical

methods to reduce lead times.

- Drive initiatives for energy efficiency and cost optimization in QA/QC processes.

- Support cross-departmental strategies to align QA activities with production and

operational objectives.

- Participate in strategic plant-wide decision-making forums to provide insights on

quality trends and risk management.