
Quality Assurance Manager
5 days ago
Key Assurance and Regulatory Compliance:
\- 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.
Manufacturing, Storage & Distribution Oversight
\- 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.
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.
Qualifications & Competencies
\- 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.
Essential Skills & Abilities
\- 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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