A
Acme Generics
Manager - Audit and Compliance
Skills
RInternal AuditSupply ChainComplianceRisk Management
21 days ago
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Important information
Contract type:
Permanent
Location:
Baddi, Himachal Pradesh, India
Work mode:
Onsite
Published on:
6 October 2026
What they need
- Ensure the site complies with all applicable regulations, including cGMP (Current Good Manufacturing Practices), FDA, EMA, MHRA, and other global regulatory requirements.
- Mange audits and inspections conducted by regulatory authorities, customers, and third parties.
- Maintain knowledge of changes in regulations and industry trends to ensure ongoing compliance.
- Plan, lead, and conduct internal audits to ensure compliance with SOPs, quality systems, and regulatory requirements.
- Track and close audit observations, ensuring corrective actions are implemented effectively.
- Prepare the site for customer and regulatory audits and lead the response to observations and findings. Develop an annual audit schedule for in-depth reviews of all operational and quality-related activities.
- Ensure a thorough review of processes, systems, and documentation to ensure compliance with internal policies and regulatory requirements.
- Introduce random, unannounced audits focusing on critical areas, like cleanliness, record-keeping, and critical equipment to ensure ongoing compliance.
- Conduct real-time reviews of batch records, validation protocols, and production practices.
- Regularly perform unscheduled walk-throughs to visually assess the state of compliance, facility cleanliness, personnel adherence to SOPs, and safety protocols.
- Use walk-throughs to engage with staff and reinforce a culture of compliance.
- Identify potential risks related to quality and compliance and implement risk mitigation strategies.
- Drive continuous improvement initiatives aimed at enhancing compliance and operational efficiency.
- Lead initiatives to streamline processes, reduce deviations, and improve overall quality performance.
- Collaborate with manufacturing, engineering, R&D, procurement, and supply chain teams to ensure quality and compliance standards are upheld.
- Act as a liaison between the site and corporate headquarters for all compliance-related activities.
- Provide regular reports to senior management on the compliance status of the site.
- Communicate with customers regarding compliance issues and updates.
- Serve as the point of contact for compliance issues within the plant and lead all compliance-related meetings.
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