Director of Quality

14 hours ago

Navi Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 1,80,00,000 - ₹ 2,00,00,000
Quality Assurance Director

Ensure the highest standards of quality are maintained across all operations. Lead and mentor a team of professionals to achieve excellence in quality management.

Key Responsibilities:
  • Develop, implement, and maintain the company's Quality Management System (QMS) ensuring compliance with regulatory requirements.
  • Establish, document, and communicate quality goals, policies, SOPs, and procedures.
  • Lead and manage internal and external audits, act as the Management Representative for all 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.
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 are maintained.
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.
Requirements:
  • 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.

Preferred qualifications include a 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.

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