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Akums Hiring for Executive- IT ( CSV) For Haridwar Job at India Full Time
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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
PLC
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 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