Quality Assurance Manager

5 days ago


Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 25,00,000

Key Assurance and Regulatory Compliance:

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- Develop, implement and maintain a quality management system (QMS) to ensure compliance with international standards such as ISO, GMP, GDP, and regulatory requirements in India.

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

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

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Manufacturing, Storage & Distribution Oversight

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- Oversee quality compliance of manufacturing, labeling, warehousing, and logistics activities including bonded warehouses. Ensure batch records, COAs, and distribution records are complete, accurate, and compliant.

- Maintain good distribution practices and optimal infrastructure for temperature, hygiene, safety, and uninterrupted operations.

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Leadership & Training

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- 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.

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Qualifications & Competencies

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- Bachelor's or master's degree in pharmacy, life sciences, or a related technical field.

- Certification in ISO 9001, ISO 13485, ISO 45001, ISO 14001, and CDSCO is mandatory. Lead Auditor qualification for these standards is an advantage.

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Essential Skills & Abilities

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- 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.



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