QA Manager

• Quality Oversight: Ensuring compliance with regulatory standards and internal quality procedures throughout the manufacturing process.
• Documentation Review: Manage and review quality-related documents, including SOPs, batch records, and quality manuals.
• Audit Preparation: Conducting internal audits and coordinate with QA Manager for external audits to ensure cGMP and regulatory compliance.
• Quality Systems Maintenance: Identifying and implementing improvements in quality systems and processes.
• Team Training: Contribute to the training and development of junior quality assurance staff.
• Product Quality Checks: Overseeing the release of finished products, ensuring they meet quality specifications.
• Validation Support: Manage validation and qualification activities for equipment, processes, and systems.
• Regulatory Compliance Monitoring: Stay informed about regulatory changes, especially for export markets, and assist in implementing necessary updates.
• QMS Support: Maintaining and improving Quality Management Systems (QMS) in line with international standards.

Candidate Profile:

• Knowledge of cGMP, WHO GMP, FDA regulations, and quality standards.
• Strong communication and teamwork skills.
• Experience in audits, regulatory inspections, and regulatory affairs (especially for exports).
• Hands-on experience with Validation and Qualification processes.
• Ability to solve problems and assist in decision-making.

Minimum Experience:

7+ years, preferably with knowledge of Validation & Qualification, Regulatory Affairs (for exports), and QMS.

Job Type: Full-time

Pay: ₹800,000.00 - ₹1,050,000.00 per year

Work Location: In person