AM/DM/ Manager - Quality Assurance

Akums

10 - 15 years

10 - 15 Lacs

dera bassi

Posted:1 day ago| Platform:

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Skills Required

validation qualification qms regulatory compliance ipqa lab qa investigation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Preferred candidate profile

Candidate must be from API/Bulk Drugs/ Chemical Industry.

Role & responsibilities

Quality System Management:
Develop, implement, and maintain quality assurance policies and procedures in line with cGMP, ISO, and other relevant regulatory standards.
Team Leadership & Mentoring:
Lead, manage, and train the QA team, fostering a culture of quality and continuous improvement.
Process & Product Quality:
Oversee quality testing activities, analyze quality trends, identify non-conformities, and ensure the final API product meets high-quality standards.
Supplier Quality Management:
Provide Quality oversight of external vendors, assess supplier qualifications, and manage API supply chain quality.
Audits & Compliance:
Plan and conduct quality audits (internal and external) and ensure full compliance with regulatory requirements, including facing international audits.
Documentation & Reporting:
Prepare, maintain, and present quality reports, test documentation, and defect tracking records.
Cross-functional Collaboration:
Work closely with development, production, and other departments to integrate quality into the product lifecycle and resolve quality issues.
Root Cause Analysis:
Conduct in-depth root cause analysis of quality issues and implement effective corrective and preventive actions.

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