
Team Member
6 days ago
Executive/Sr Executive
Job Grade (refer to JE
G12A/G11B
Function:
IT
Location:
Baroda
Areas Of Responsibility
List of Responsibilities / Job function:
To work as per cGMP and ensure its compliance as per current guideline and SOPs.
Instrument application support with help of respective system vendors.
To ensure the Laboratory Software are validated as per defined Global Procedures.
To perform the assigned activities in the role of Technical Owner/System Administrator, and also performs software validation of new/existing instruments in laboratory in the role of Technical Owner and System Administrator as per requirement.
Responsible for User Creation\Modification\Deactivation\Reactivation in Lab system as per UAM.
Responsible for Preparing Active user list & periodic user access review of computerized system.
To maintain and secure 21 CFR part 11 compliance of Software / instrument / Equipment available in laboratory.
Responsible to take training before execution of allotted work & maintaining the training file.
Responsible for securing the Login/ Passwords as "Administrator" of software/ instrument/ Equipment available in Labs.
Responsible to follow Quality Management Document procedure.
Time synchronization of standalone balances
Project Backup & Restoration activities for software's in Lab systems.
Responsible for execution of Installation, qualification and validation of systems.
Responsibility to Support user for application related issue with the help of vendor.
Responsible to inform reporting authority for any non-compliance/event occur during execution of GMP activities.
Responsible to escalate quality related issues to management and resources requirement.
Responsible as Administrative rights holder for Software/instrument/Equipment available in CAL, ADD, ADD-Development & PE Laboratory.
To prepare and implement the CS\CSAP related to system control policy & user management for Laboratory Software.
Support to Audit trail review activity for all GxP systems
Support to perform Periodic User access review and Privileges verification for GxP systems
Responsible for project creation\lock\relock and unlock in respective application e.g. Empower, Chromeleon, Mass lynx, Lab Solution, XRD, Spectrum, POL, tem etc.
Coordinate with Site QA IT and CQ IT for compliance of computer system quality management as per GSOPs.
Remote Application support as and when required.
Other job responsibilities assigned by reporting authority.
Responsible for ADD-IT Department for Log book Issuance as per requirement.
Travel Estimate
Job Scope
Job Requirements
Educational Qualification
Degree in Electronics & Communication Engineering
Experience
Skill (Functional & Behavioural):
Technical & Conceptual skill Creativity and Innovation Basic knowledge of MS office (Word, Excel & Power point
Behavioral Competencies / Soft Skills: Effective communication skill Flexibility Empathetic, Integrity & Time management Listening skills Learning from other
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s
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