Chief Manager - Information Technology - Pharma

Chief Manager - IT CSV/QA (Pharma)

- 14-18 years of experience in Pharma/Life science domain working on CSV, Part 11/Annex 11, Data Integrity, IT Automation - IoT, RPA, AI/ML etc.

Experience of validation of Enterprise IT systems - SAP, Trackwise, DMS, LMS etc.

Experience of working in IT and Pharma domain (preferably at site)

KEY RESPONSIBLITIES:

To ensure compliance of IT and Electronic systems hosted centrally and at sites.

Work closely with site teams to identify and implement automation for quality processes

- To define policy, guidelines and SOPs for CSV and GXP IT processes - Change Management, Periodic Reviews, Audit Trail Reviews, Incident etc.

- To conduct trainings for the CSV team, IT team and business teams at the sites on CSV, GAMP5, 21 CFR Part 11, DI, Supplier Assessments, Periodic Reviews etc.

- Improve efficiency of validation and testing activities. Bring in more automation and risk based approach to reduce the workload and documentation burden.

- Support in creating and presenting MIS and other dashboards to management team

- Get involved in critical projects for review of validation documents and reports

- Define metrics to measure KPIs, productivity of the team and efforts estimate

- Support the corporate team and sites during regulatory and client audits.

- Support Corporate QA team in conducting internal GMP and DI audits of sites.

- 30% travel expected for this role to visit the sites and work with site teams.

- Manage the QeC team and empower and develop them to take up bigger role.

- Manager stakeholders - Business, Vendors, Contract resources, IT team and project and operational escalations.

SKILLS AND COMPETENCIES:-

- To have in depth understanding of regulatory requirements and guidelines required to comply IT systems in Pharma industry - DI, Part 11, Annex 11, GAMP 5 etc.

- Knowledge of IT frameworks - COBIT, CMMi, ISO 27000, ITIL processes (e.g. Backup/Restoration,

- Infrastructure qualification, User access Management, etc.)

- Knowledge of Pharma domain - Manufacturing and Quality (QA, QC)

- Understanding and exposure on LIMS, MES etc.

- Aware of Pharma 4.0 technologies - RPA, IOT, AI/ML etc.

- Experience of working at Pharma Site - QC, QA, IT, CSV etc.

- Aware of industry best practices and exposure to CSA

- Experience of team management

- A team player with good communication skills (verbal & written)

- Any other tasks as assigned by his/her reporting manager