QMS - Executive
Alkem Laboratories · Daman · onsite · Posted 24d ago
Not disclosedFresherfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
QMS Management
- Manage and maintain site Quality Management System procedures.
- Ensure timely processing and closure of Deviations, Incidents, investigations, CAPAs, Change Controls, and Risk Assessments.
- Review trend analysis of quality events and identify improvement opportunities.
- Track CAPA implementation and effectiveness verification.
- Ensure timely closure of corrective and preventive actions.
- Conduct periodic CAPA review meetings with stakeholders.
- Review and coordinate change control proposals.
- Assess quality and regulatory impact of proposed changes.
- Monitor implementation and closure timelines.
- Review SOPs, protocols, reports, and quality documents.
- Ensure compliance with GDP (Good Documentation Practices).
- Maintain QMS records in electronic systems.
- Conduct QMS awareness and GMP training programs.
- Support employees in understanding quality systems requirements
- Facilitate investigation of deviations, incidents, Market complaints, OOS, and OOT cases.
- Ensure root cause analysis using appropriate tools.
- Support closure and effectiveness verification of action plans.
Sourced from foundit
Skills
Root Cause AnalysisDocumentation & ComplianceChange Control Management
About Alkem Laboratories
Alkem Laboratories
Pharma
18.8k+
employees
1973
53 years old
Mumbai, Maharashtra
India
About
A leading player in the Indian pharmaceutical sector, specializing in generics and specialty drugs, committed to enhancing healthcare globally.
Industries
PharmaHealthcare / PharmaBiotechnology
Employee ratings
3,510 reviews
3.9/ 5
Culture
3.6
Career growth
3.5
Work-life
3.8
Employees rate it well for
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