Executive- IT

From 4 to 6 year(s) of experience
- ₹ Not Disclosed by Recruiter
- Haridwar***

**Job Description**:

- GAMP 5 and V-model based validation of IT systems.
- IT compliance with respect to regulatory requirement.
- Responsible for IT compliance function at all site.
- Enhance IT related controls on all quality control instruments with respect to current GMP requirements at all sites of organization.
- Review and implement Information Technology Standards at all sites.
- Review of Compliances on daily basis as per Internal Inspection and received immediate Corrective and Preventive Action from concerned with effective implementation.
- Review the IT related compliance of customer audits for its adequacy.
- Review of qualification documents such as URS, DQ, IQ, OQ, PQ and validation protocols and report.
- To ensure desktop policies are in the place as per regulatory requirement.
- To check the validation/ qualification and re-qualification of the HPLC/ Instrument and document computers as per regulatory compliance.
- Ensure the system related training of employee as per their job allocated.
- Ensure the timely implementation of the IT SOP and guideline.
- Be a part of internal audit and ensure the 100% compliance as per the SOP.
- Sound knowledge of QMS/ LIMS/ SAP and Pharma LAB related softwares.
- Having knowledge of HMI/ PLC backup process.
- Having knowledge of SCADA and its workflow including backup process.
- Sound knowledge of Pharma compliance/ IT policies and SOP’s.
- Familiar with Active Directory policies and implementation.
- To know the Disaster Recovery Plan and Business Continuity Plan.
- Well familiar with 21 CFR Part 11 and GAMP-5.
- Have Capability to understand business requirement with innovative way.
- To prepare and maintain all IT SOP.
- Responsible for Data Integrity w.r.t. 21 CFR Part-11 and Regulatory standards.

Role:

- IT & Information Security - Other- Salary:

- Not Disclosed by Recruiter- Industry:

- Pharmaceutical & Life Sciences- Functional Area:

- IT & Information Security- Role Category:

- IT & Information Security - Other- Employment Type:

- Full Time, Permanent- Key SkillsPLC

21 Cfr

Computer System Validation

LIMS

HMI

GAMP-5

QMS

CSV

HPLC

Auditing

Information Technology

SCADA

Skills highlighted with ‘‘ are preferred keyskills
- Education- UG:

- B.Tech/B.E. in Any SpecializationCompany Profile
- Akums-
- Company Info Contact Company:
Akums