Harman Finochem Limited is a leading India-based Pharmaceutical Company which specializes in the manufacture and export of more than 45+ Active Pharmaceutical Ingredients (APls) of which 10+ are Essential Drugs as per the WHO Model List. We deliver top quality products to more than 75+ countries across the globe.
Harman Finochem For Following:
- Qualification : M.Sc./B.Sc.
- Experience : 04-08+years
- Department: IT
- Role: IT Officer/Sr. Officer
- Job Location: Aurangabad,Maharashtra
- No.of Openings: 01
Interested candidates can share their profile on [email protected]
Job Description.
- Function as IT compliance person on multiple assigned infrastructure projects for hardware replacements, upgrades, OS and Database patches and/or modifications to infrastructure needed to support quality systems and applications. Projects may include IAAS, PAAS, virtualization, and datacentre qualifications.
- Infra background and knowledge of different Pharma compliance like US FDA, GDPR, CSV, Part 11, GXP, 21 CFR part 11 validation etc
- Take care of Chromeleon and Empower Servers, Managing & Monitoring.
- Create new database / projects / folders yearly and monthly, Users & assign authorization rights in all QC instrument computers
- monitor & Take weekly and monthly back-up and retrieval of QC instrument computer as per SOP
- Develop strategy for the qualification aspects of the project, using a risk-based approach to determine testing, documentation and verification activities, with appropriate justification of the approach.
- Represent Infrastructure during internal and regulatory audits.
- Develop new/ Fine-tune Centralised SOP (Standard Operating Procedures)
- Ensure processes are executed as defined in SOP
- Conduct internal audits to identify gaps and work to fill the gaps.
- As necessary, modify/create Qualification Plan, Protocols, and Test Plans, Risk / security Assessments, Reports, Trace Matrix and SOPs.
- Manage qualification testing coordinating documentation and testing activities. Generate test scripts, as needed. Execute testing as required .
