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About this role
Job Description
Ensuring compliance with applicable cGXP regulations.
Adherence to data reliability, accountability and consistency & data governance procedure and ensuring the compliance in the department through the established/written procedures/policies.
Handling of internal and external regulatory audits.
To ensure user management and data security policy as laid down by the company.
Ensuring the awareness on organization’s quality policy in the department.
Ensuring, enabling, enhancing the required level of knowledge, skill, competency at various level of personnel working in the department through internal/external training.
Management and upkeep of resources/ equipment /assets / instrument in the department and ensuring the compliance level.
Ensuring the safety norms as per EHS policies/guidelines.
Compliance for the services taken from the external agencies.
Creation and Review of training modules on technical topics of relevance and conduct training.
Ensuring the Competency based training approach in quality control and production.
Ensuring smooth functioning of L2LMS (Lupin Learning Management system).
Ensuring high level of awareness regarding data governance and data integrity at site.
Ensure SOP, cGMP, Functional and Certification training compliance at Site.
Responsible for Compliance of Contractual Employee training.
Will be the focal point for coordinating any external technical training program at site.
Actively participate in the entire flow of training activities at site viz. Induction training (for the technical briefings) Need identification and derivation of training plan. Training conduct. Training evaluation. Feedback for trainer. Training documentation. 18. Ensuring training of the trainers. Will be responsible for submitting the monthly summary of training happenings at site to corporate. Responsible for collating and interpreting data that are needed for evaluating training effectiveness.
