Manager - Audit and Compliance

Acme Generics Pvt. Ltd.; Solan; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Acme Generics Pvt. Ltd. is seeking a dedicated Compliance Lead to ensure site adherence to global regulatory requirements and quality systems.

You will manage regulatory inspections and lead response activities, develop audit schedules, and drive ongoing improvement across production and quality functions. The role requires hands-on oversight of batch records, SOP compliance, risk mitigation, and cross-functional collaboration with manufacturing, R&D, engineering, procurement, and supply chain

Responsibilities

• Ensure the site complies with all applicable regulations, including cGMP (Current Good Manufacturing Practices), FDA, EMA, MHRA, and other global regulatory requirements.
• Manage 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.

Job description

1. Ensure the site complies with all applicable regulations, including cGMP (Current Good Manufacturing Practices), FDA, EMA, MHRA, and other global regulatory requirements.
2. Mange audits and inspections conducted by regulatory authorities, customers, and third parties.
3. Maintain knowledge of changes in regulations and industry trends to ensure ongoing compliance.
4. Plan, lead, and conduct internal audits to ensure compliance with SOPs, quality systems, and regulatory requirements.
5. Track and close audit observations, ensuring corrective actions are implemented effectively.
6. 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.
7. Ensure a thorough review of processes, systems, and documentation to ensure compliance with internal policies and regulatory requirements.
8. Introduce random, unannounced audits focusing on critical areas, like cleanliness, record-keeping, and critical equipment to ensure ongoing compliance.
9. Conduct real-time reviews of batch records, validation protocols, and production practices.
10. Regularly perform unscheduled walk-throughs to visually assess the state of compliance, facility cleanliness, personnel adherence to SOPs, and safety protocols.
11. Use walk-throughs to engage with staff and reinforce a culture of compliance.
12. Identify potential risks related to quality and compliance and implement risk mitigation strategies.
13. Drive continuous improvement initiatives aimed at enhancing compliance and operational efficiency.
14. Lead initiatives to streamline processes, reduce deviations, and improve overall quality performance.
15. Collaborate with manufacturing, engineering, R&D, procurement, and supply chain teams to ensure quality and compliance standards are upheld.
16. Act as a liaison between the site and corporate headquarters for all compliance-related activities.
17. Provide regular reports to senior management on the compliance status of the site.
18. Communicate with customers regarding compliance issues and updates.
19. Serve as the point of contact for compliance issues within the plant and lead all compliance-related meetings.