FULLTIME
Manager - Audit and Compliance
Acme Generics LLP
Not specified · onsite · Posted 12d ago
Sourced from
Undisclosed10–16 yrsfulltimeNot specified
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Section · 01
About this role
- 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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Section · 02
Skills
Audit ComplianceRisk ManagementAudit Management
Section · Company
About Acme Generics LLP
Acme Generics LLP
Pharma
2.5k+
employees
2005
21 years old
Baddi, Himachal Pradesh
India
₹3.9L PA avg
Avg at Acme Generics LLP
About
Pharma Manufacturing
Industries
Pharma
Employee ratings
10 reviews
3.7/ 5
Culture
2.3
Career growth
2.6
Work-life
2.7
Employees rate it well for
Compensation & Benefits37Skill Development37
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