Job Details
Position : Manager IT
Job Location : Nashik, Maharashtra
About the company:
One of the leading names in Pharmaceutical (API) Manufacturing Industry.
Job Requirement:
BE / B. Tech / MCA in Computer with Min. 15 Years’ of experience in IT (Information Technology) department from Pharma API Industry.
Job Role:
Having Experience Implementation software Project
Evaluation & testing of IT products for ongoing needs.
Having Experience IT operations
Having experience IT services and consulting functional area.
The incumbent should be well versed with Latest Hardware, cloud, networking, IT security and Software skills, the incumbent is also expected to continuously update himself with the latest Development in IT field.
Leads a team of IT professionals to drive alignment of the IT Application Architecture for
Domains and development and execution of the application architecture roadmap;
Having experience Project management.
Having experience implantation pharmaceutical application eg. Caliber LIMS, QMS, DMS LMS,
Track wise, Chromeleone 7.3, Ample Logic LIMS.
Responsible to validate/revalidate the GxP Computerized Systems located in QC, laboratory,
Manufacturing, warehouse, engineering, QA, IT departments.
Responsible to validate/revalidate web-based applications, corporate applications, Infrastructure
Applications.
Responsible to define the validation strategy and qualification strategy for Retrospective and
Prospective systems validation.
Responsible to prepare or review the validation plan, protocols and reports.
Responsible to review the validation deliverables in project initiation phase – User Requirement
Specifications (URS) and GxP Assessment.
Responsible to participate vendor qualification and review the report.
Responsible to review the validation deliverables in specification phase Functional Specifications,
Design Specifications, Configuration Specifications, Technical Specifications, etc.
Responsible to review the Risk Assessments and Mitigation actions to ensure compliance during
And after system validation.
Responsible to review the validation deliverables in testing phase – Installation Qualification (IQ),
Operational Qualification (OQ) and Performance Qualification (PQ).
Responsible to review the validation deliverables in reporting phase – Requirement Traceability
Matrix (RTM) report, 21 CFR Part 11 Assessment, Summary reports.
Responsible to review the computerized systems inventory list.
Responsible to author or review the computerized systems validation SOP’s.
Responsible to keep updated on regulations (21 CFR Part 11, EU Vol4 Annex 11, etc.) and Guidelines (ISPE GAMP5, PIC/s, ICHQ9, etc.) related to computerized systems validation.
Handling standalone system user Management eg. IR,UV, GCMS, XRD
Handling Data backup application Arcserve, Veritas.
Handling Network Validation.
Handling Chromeleon 7.3 application User Management and Database server
Contact Person : Mital Nakhate
Email : [email protected]
Interested candidates can directly APPLY on the below link
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