Deputy Manager - Quality IT

☞ Piramal Enterprises

View: 101

Update day: 25-05-2024

Location: Mumbai Maharashtra

Category: Pharmacist / Pharmaceutical representatives

Industry:

Loading ...

Job content

Job Overview
The primary objective of the role is to manage and lead the IT support team & related support activities for all corporate GxP quality application like ENSUR, Harmony, PharmaREADY, TrackWise etc.
Key Stakeholders: Internal
Business – PPS, PCC, PPL, CPD sites / Corporate functions / Cross functional IT teams .
Key Stakeholders: External
IT Vendors, IT Contractors/Consultants & Various Service Providers
Reporting Structure
Role reports to Chief Manager – IT
Experience
6 – 8 years of experience in Pharma/Life science domain working on IT support, Part 11/Annex 11. • Relevant experience in both IT and Pharma sector will be desirable.

Competencies
Good knowledge of GxP Quality application support activities in pharma domain. • A team player with good communication skills (verbal & written). • Author, review and approval of SOPs, Guidelines/Policies as applicable. • Good knowledge of 21 CFR Part 11 / EU Annexure 11 (Must) • Basic knowledge of CSV, GAMP 5 (Must) • Good knowledge of Data Integrity requirements for Pharma (Must) • Good Verbal and Written communication skills (Must) • Knowledge of IT systems and ITIL processes (For e.g., Backup/Restoration, Infrastructure qualification, User access Management, etc.) (Must)
Responsibilities
Responsible for managing IT support team & related activities for all quality application like ENSUR, Harmony, PharmaREADY, TrackWise etc. • Responsible for Administration and configuration management of all quality application. • Project Implementation support for all quality applications like TrackWise, Harmony, eForms etc. (as and when required) • Responsible for user access management for all quality management systems -For e.g., ENSUR, Harmony, PharmaREADY, TrackWise etc., as and when required. • To support in SOP creation for IT Systems and ensure effectiveness of processes during operational phase. • Participate in elicitation of business requirements for ENSUR all quality application projects. • Impart training on Ensur to users at Corporate & Sites as and when required. • To provide support and maintain operational state of quality application. • To perform and support during quality application data migration activities. • To initiate change control, Deviation CAPA in TrackWise QMS application and to perform implementation of change control and other QMS activities. • To ensure and maintain 21 CFR Part 11, EU Annex 11, Data Integrity as per ALCOA+ requirement controls for computerized system, as applicable. • To support QeC during Audits/Periodic & Audit trail review of corporate quality IT application. • To support corporate quality application implemented sites during their Audits. • Checks the ticketing system on regular basis to ensure that all the logged issues are addressed at the earliest. • To support in backup and restoration verification activities for corporate quality applications


Loading ...
Loading ...

Deadline: 09-07-2024

Click to apply for free candidate

Apply

Report job
Loading ...
Loading ...

SIMILAR JOBS

Loading ...
Loading ...