Senior Manager QA/QC job vacancy at Indore in Symbiotec Pharmalab

Position: Sr. Manager– Quality Assurance

Education: M.Sc. or Ph.D. Additional education will be added advantage

Experience: around 15 years of experience in quality assurance. He shall have faced regulatory audits for complex products.

Location: Indore (M.P)

The Quality Assurance Manager plays a crucial role in ensuring that all aspects of the API manufacturing process comply with regulatory standards and meet the required quality levels.

The key responsibilities include:

1. Developing and implementing quality assurance policies and procedures specific to production and quality control.
2. Overseeing the quality control processes to ensure that raw materials, intermediates, and final API products meet established specifications.
3. Leading investigations into quality issues, non-conformances, and batch failures to identify root causes and implement corrective actions.
4. Collaborating with cross-functional teams, including Production, R&D, and Regulatory Affairs, to drive continuous improvement in quality systems.
5. Conducting risk assessments and quality audits to monitor compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.
6. Managing the documentation system related to quality assurance, including batch records, SOPs, and validation protocols.
7. Training and developing staff on quality standards, processes, and regulatory changes.
8. Participating in regulatory inspections and audits and ensuring timely responses to any findings or observations.
9. Implementing robust change control and deviation management processes to maintain quality standards during process changes.
10. Staying current with industry trends, regulatory updates, and best practices in API quality assurance.
11. Communicating with customers and/or regulators on the specific points/issues related to the product.

Interested person may send their updated cv