Manufacturing Associate

6 days ago

Indore Madhya Pradesh, India Endo International Full time

Job Description Summary

Responsible to coordinate internal and external audits for sterile injectable operations, ensuring readiness and compliance with regulatory.

Job Description
- Responsible to ensure all processes and documentation comply with cGMP, regulatory guidelines, and company policies, addressing any gaps promptly.
- Work with Quality function in understanding and implementation of PAR Quality Management Systems (QMS) in operations.
- Oversee the preparation, review, and submission of auditrelated documents, including CAPA (Corrective and Preventive Actions) reports, deviations, and audit responses
- Review, implement and maintain cGMP in all related work areas.
- Responsible to Conduct training programs for employees to enhance awareness of audit standards and regulatory requirements, promoting a culture of compliance.
- Responsible to Identify potential compliance risks in sterile injectable processes and recommend corrective measures to mitigate them effectively. - Responsible for preparation, review, and submission of audit related documents, including CAPA (Corrective and Preventive Actions) reports, deviations, and audit responses.
- Notification to management for any critical major issues.
- To ensure and maintain Code of conduct for self and team. Ensure discipline and security of the site.
- To ensure that safety incidents are reported, investigated, and closed in time.
- To ensure compliance to EHS as per PAR global requirement.
- Focus and implementation of continuous improvement of plant process.

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