Key Responsibilities:

Quality Assurance & Regulatory Compliance :

- Develop, implement, and maintain the company's Quality Management System (QMS) ensuring compliance with ISO, GMP, GDP, and Indian regulatory requirements.

- Establish, document, and communicate company-wide quality goals, policies, SOPs, and procedures.

- Lead and manage internal and external audits, act as the Management Representative for all ISO certifications.

- Approve SOPs, WI, format templates, validation protocols, and batch-related documentation.

- Review and authorize release or rejection of raw materials, packaging materials, intermediates, and finished goods.

- Monitor and improve CAPA systems, change controls, deviation handling, and complaint investigations.

- Act as SPOC for key clients regarding audits, quality queries, operational challenges, and approval processes (labels, CCFs, etc.).

- Coordinate cross-functional quality reviews and provide support during regulatory/customer audits.

- Manage temperature mapping activities and approve reports to ensure product integrity in storage and transit.

- Support QA team at all sites for technical queries, investigations, and compliance-related issues.

Manufacturing, Storage & Distribution Oversight:

- Oversee quality compliance of manufacturing, labelling, warehousing, and logistics activities including Custom Bonded Warehouses.

- Ensure batch manufacturing and packing records, COAs, and distribution records are complete, accurate, and compliant.

- Ensure Good Distribution Practices (GDP) and optimal infrastructure (temperature, hygiene, safety) are maintained.

- Coordinate with Production, Stores, Procurement, and Sales teams for uninterrupted quality-compliant operations.

Leadership & Training:

- Lead and mentor QA and EHS teams across multiple locations.

- Train internal auditors and ensure staff competencies in ISO, GMP, and safety standards.

- Provide timely reports to senior management on system performance, non-compliances, and improvement actions.

- Promote a culture of quality, safety, and continuous improvement within the organization.

Qualifications:

- Bachelor's or master's degree in pharmacy, Life Sciences, or a related technical field.

- Certification in ISO 9001, ISO 13485, ISO 45001 IS0 14001 ISO 27001, CDSCO is mandatory

- Lead Auditor for ISO 9001, ISO 13485, ISO 45001 IS0 14001, ISO 27001, CDSCO qualification is a strong advantage.

Skills & Competencies:

- In-depth knowledge of QMS, GMP, GDP, and regulatory compliance.

- Strong leadership, audit management, and team development skills.

- Proficient in deviation handling, CAPA, RCA, and risk assessment.

- Excellent communication, documentation, and problem-solving abilities.

- Ability to handle multi-site operations and cross-functional collaboration.