Harman Finochem Job vacancy – Submit Resume

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 b6admin@harmanfinochem.com

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 .