QA Manager
4 days ago
- 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, ₹1,050,000.00 per year
Work Location: In person
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