Sr. Manager – IT QA

Role / Position Title:

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OVERALL JOB RESPONSIBILITIES

1. To oversee and support in implementation, validation and management of GxP computerized systems (e.g. Manufacturing, Laboratory, eBMR, L2 Integration, LIMS) used at site throughout the lifecycle by providing a sound understanding of validation, qualification, testing requirements and periodic reviews.

2. To have Quality oversight on GxP computerized systems, Computer System Validation (CSV), Data Backup/Restore, IT documentation and QMS and ensuring compliance with regulatory standards, IT policies and procedures through periodic audits / quality reviews.

3. Review and approval of CSV lifecycle documents, ensuring they incorporate all regulatory requirements and in line with site procedures.

4. Collaborate with project managers to identify potential risks and develop mitigation strategies during project lifecycles.

5. Conducting assessments of GxP Computerised System projects during implementation and maintenance.

6. Support internal and external audits by providing necessary documentation, evidence of compliance, and explaining CSV and IT compliance related processes.

7. Assessment of supplier and service providers w.r.t regulatory and business requirements.

8. Planning and execution of routine audits of GxP computerized systems, processes, and documentation to identify gaps and areas for improvement.

9. Planning and execution of periodic reviews of GxP computerized systems per relevant procedures.

10. Support in reviewing of system audit trails of GxP computerized systems as per site procedure.

11. Collaborate with Supplier, QA and IT teams to address audit findings and implement corrective and preventive actions (CAPAs).

12. Approval of User Access Management for the end users in accordance with the defined procedure.

13. Review and approval of standard operating procedures (SOPs) and follow periodic training and evaluation plan for the team members.

14. To impart training to internal and external stakeholders on cGMP topics, IT-Quality and SOPs. Assign training content for New/ Revised Policy and procedural documents in LMS. Tracking of training completion for assigned item in Aspire LMS and ensuring completion for same to ensure training compliance.

15. Review and assessment of QMS events related to GxP computerized systems.

16. Collaborate with cross-functional teams to ensure quality standards for GxP computerized systems and data integrity.

Proactive risk / impact assessment prior to implementation of any change to ensure effective implementation.

KEY INTERFACES / INTERACTIONS:

External Interfaces:

Internal Interfaces ( Other than Direct Reports):

• GM IT
• Glenmark Department Function Heads
• Production and Engineering ,Quality depts.
• Glenmark IT SPOCS

KNOWLEDGE, SKILLS, AND ABILITIES

Education

(degree/diploma):Graduate from any recognized university

Experience

Knowledge and Skills

• Technically sound
• Should be able to understand the customer's needs
• Project requirements and Executions

Leadership / Managerial Attributes:

• Co-ordinating within the IT team
• Effective utilization of resources
• Seamless coordination with the stakeholders