Job Title:

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

6+

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).