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• No of position :- ( 1 )

• Post :- 7th Apr 2021

IT Controls methodologies, including GAMP5 and ITIL

Resource will provide dedicated support for various laboratory systems within our state-of-the-art pharmaceutical facility.

Responsibilities include but are not limited to:


Provide software support for various laboratory systems such as Maldi-TOF, Coulometer, qPCR etc.. in Pharmaceutical Operations

Support the Pharm Ops Quality Control Operations department in preventing unplanned downtime of their systems.

Adhere to the requirements of “Segregation-of-Duties” in the management of the systems in scope.

Demonstrated leadership skills with a proven track record of driving continuous improvement

Excellent communication and interpersonal skills with the ability to influence others with impact

Advanced knowledge of system vulnerabilities and security issues.

Monitor the system daily and respond immediately to security or usability concerns.

Create and verify backups of data

Respond to and resolve help desk requests

Upgrade systems and processes as required for enhanced functionality and security issue resolution

Manage the configuration and operation of client-based computer operating systems

Qualifications:

Education Requirement:

Bachelor’s Degree in Computer Science, Management Information Systems or equivalent degree.

At least 2 years of experience working in a similar position in Bio-Technology, or Life Science industry

Required Experience and Skills: 


MUST have thorough understanding of IT Controls methodologies, including GAMP5 and ITIL.

Thorough knowledge of computer validation/SDLC requirements and change control procedures 


Effective verbal or spoken communication skills

Good communication skills in English

Preferred Experience and Skills:

At least 3 years of experience working in a similar position within a GxP regulated environment

Sufficient experience in GxP validated, 21 CRF Part 11 compliant computer systems

Adequate experience in backup & recovery tools such as VMware, Acronis &  Robocopy

Lab cots System –it support GMP