Assistant Quality Assurance Manager

Sami Sabinsa Group

10 - 18 years

7 - 11 Lacs

kunigal

Posted:2 days ago| Platform:

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Skills Required

quality assurance capa change control qms

Work Mode

Work from Office

Job Type

Full Time

Job Description

Quality Management System (QMS):
Implement and maintain QMS in line with cGMP and regulatory requirements.
Review and control SOPs, specifications, master documents, and records.
Ensure timely execution and closure of change controls, deviations, CAPA, and risk assessments.
Support continuous improvement initiatives in QMS processes.
Audit & Compliance:
Prepare and participate in internal, external, customer, and regulatory audits (e.g., USFDA, MHRA, WHO, EU).
Ensure audit observations are tracked, addressed, and closed within timelines.
Conduct periodic self-inspections to ensure plant-wide compliance.
Document Control:
Manage issuance, retrieval, archival, and control of GMP documents.
Ensure timely review and approval of batch records, logbooks, and quality documents.
Training & Awareness:
Organize and deliver GMP/QMS-related training sessions to employees.
Monitor training effectiveness and maintain training records.
Change & Deviation Management:
Evaluate and approve changes related to processes, equipment, and systems.
Investigate deviations, identify root causes, and ensure timely CAPA implementation.
Regulatory Support:
Support preparation of documents for regulatory submissions and inspections.
Ensure compliance with international regulatory standards.
Quality Risk Management:
Perform risk assessments related to quality incidents, processes, or systems.
Propose risk mitigation and monitoring strategies.
Cross-functional Collaboration:
Coordinate with production, QC, engineering, and warehouse teams to resolve quality-related issues.
Act as QA representative in cross-functional project meetings.

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