Akums Looking for Executive- IT ( CSV) For Haridwar at Haridwar, Uttarakhand Full Time

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 Skills

PLC21 CfrComputer System Validation

LIMSHMIGAMP-5QMSCSVHPLCAuditingInformation TechnologySCADA

Skills highlighted with ‘‘ are preferred keyskills

Education

UG:B.Tech/B.E. in Any Specialization

Company Profile

Akums

Akums Drugs & Pharmaceuticals Ltd., is largest contract manufacturing company engaged in manufacturing of pharmaceutical formulation, ayurvedic/herbal preparations, hormones, nutraceuticals and more.Quality, innovations & customer satisfaction are virtues at Akums. The approach is technologically driven to serve the emerging needs in the ever expanding market. The 9 state of art facilities are dedicated to separate dosage forms across therapeutic segments. The infrastructure is equipped with sophisticated and ultra modern equipments & machines, with huge manufacturing capacities in all sections.In our continuous pursuit of Healthier today and tomorrow, we are working towards redesigning global healthcare.Akums Corporate Movie : https://www.youtube. com/watch?v=-fXYxLwuksY

Company Info

Contact Company:Akums