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Parekh Integrated Services - Head - Quality Assurance

Parekh Integrated Services - Head - Quality Assurance

Parekh Integrated ServicesNavi Mumbai, India
30+ days ago
Job description

Key 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 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.

    • (ref : iimjobs.com)

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