Compliance Executive/Asst. Manager

Galentic Pharma; Gandhidham; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Galentic Pharma in Gandhidham, Gujarat, India seeks a dedicated GxP Compliance Auditor to lead and implement robust compliance programs, develop internal controls, and train staff on regulatory requirements. The role involves planning, conducting audits, and guiding corrective actions to ensure adherence to quality systems and data integrity.

You will mentor colleagues, prepare audit documentation, and support regulatory affairs, ensuring inspection readiness and ongoing compliance across

Job description

• 1. Develop and implement an effective legal compliance program
• 2. Create sound internal controls and monitor adherence to them.
• 3. Educate and train employees on regulations and industry practices.
• 4. Proactively audit processes, practices and documents to identify weakness.
• 5. Develop Corrective and Preventive Action (CAPA) plans and facilitate resolution of audit findings.
• 6. Provide oversight and participate in the planning, preparing and conducting investigator site, process, quality system, computer system, vendor qualification audits.
• 7. Provide mentorship to others conducting auditing activities.
• 8. Preparation of audit plans, reports and required audit documentation. 9. Coordinate internal and external reviews and finalize documents according to project timelines & Responsible for the professional development of colleagues.
• 10. Serve as internal GxP compliance subject matter expert, advising staff, developing training and providing expert consulting on regulatory compliance, monitoring processes and application of new regulations and guidelines to internal work processes.
• 11. Develop and lead training sessions internally/externally regarding audit or inspection readiness.
• 12. Develop and maintain SOPs, work practices, forms and other documentation and training materials related to GxP compliance and auditing services.
• 13. Provides leadership, mentor and develop personnel by maintaining a positive work environment.
• 14. Set plans to manage a crisis or compliance violation.
• 15. Address employee concerns or questions on legal compliance.
• 16. Identify & control data integrity issues and Ensure good documentation practice.
• 17. Review and approval of activity related to Lab QA.
• 18. Support to regulatory department
• 19. Data & report compilation of Self inspection.
• 20. Electonic data review of automated software's system.
• 21. Any additional work assigned by HOD. 22. In absence of employee, other same/above level employee in department shall be responsible for the activities.