Key Responsibilities

1. Quality Management System

- Lead and continuously improve the site Quality Management System (QMS).

- Establish, review, and approve quality policies, procedures, specifications, and standards.

- Ensure effective management of deviations, CAPA, change controls, OOS/OOT investigations, complaints, and product quality issues.

- Monitor quality KPIs and drive timely closure of quality actions.

- Promote a proactive, risk-based approach to quality management.

1. GMP &
- Regulatory Compliance

- Ensure compliance with applicable GMP requirements and regulatory standards, including US FDA, EU GMP, WHO GMP, PIC/S, and local regulatory requirements, as applicable to the site.

- Maintain inspection readiness at all times.

- Lead responses to regulatory observations and ensure sustainable implementation of corrective and preventive actions.

- Keep the organization updated on relevant changes in regulatory and GMP expectations.

1. Quality Assurance

- Provide independent QA oversight of manufacturing, packaging, warehousing, and other GMP activities.

- Ensure batch documentation is reviewed and products are released only when all quality requirements are met.

- Oversee validation and qualification activities, including process, cleaning, equipment, utilities, computerized systems, and analytical methods.

- Approve critical quality-related documents and decisions.

1. Quality Control

- Oversee QC laboratory operations, including chemical, microbiological, and analytical testing, as applicable.

- Ensure laboratory compliance, method validation/verification, instrument qualification, calibration, and stability programs.





- Drive laboratory efficiency without compromising scientific rigor or compliance.

1. Audits &
- Inspections

- Lead preparation for and management of customer, corporate, and regulatory inspections.

- Oversee internal and external GMP audits.

- Ensure audit observations are appropriately investigated and CAPAs are implemented effectively and on time.

- Track recurring observations and identify systemic improvements.

1. Product Quality &
- Risk Management

- Lead product quality risk assessments and ensure appropriate risk mitigation.

- Monitor trends in deviations, complaints, OOS, stability, process performance, and other quality indicators.

- Participate in product and process improvement initiatives.

- Ensure effective product quality review / annual product quality review processes.

1. Quality Culture &
- People Leadership

- Build a strong culture of quality, compliance, integrity, and continuous improvement.

- Lead, coach, and develop QA/QC teams.

- Establish clear objectives, competency requirements, and training plans.

- Ensure adequate staffing and succession planning for critical Quality roles.

- Conduct regular GMP and quality awareness programs across the organization.

1. Cross-Functional Leadership

- Partner with Manufacturing, Engineering, Regulatory Affairs, Supply Chain, EHS, and other functions.

- Provide quality input into new product introduction, technology transfer, process changes, and capacity expansion.

- Balance business requirements with uncompromising standards for product quality, patient safety, and regulatory compliance.

Pay: ₹900,000.00 - ₹1,500,000.00 per year

Perks

- Provident Fund

Work Location: In person

📌 Quality Head (Nagpur)
🏢 Ankit Pulps & Board
📍 Nagpur