Quality Analyst

Job Description:

Responsible for the development and execution of validation protocols according to company policies, procedures, user requirements and industry standards.

Major Activities

Ensure compliance to respective system management SOP`s with respect to user groups and privileges.

1. Demonstrate compliance to the established policies, guidelines and standard operating procedure.

2. Ensure IT security policies are implemented, maintained and followed.

3. To support investigations in functional areas.

4. Timely communicate/discuss identified gaps to responsible team. Coordinate with relevant team for compliance/closure of the identified gaps.

5. Perform periodic access review of Lead-lab systems with the support of relevant stakeholders.

6. Ensure timely completion of the assigned trainings (Individual as well as team).

7. To support drafting SOP/WI for Lab IT support.

8. Preparing Guidance document for Lab IT support team.

9. Ensure change controls in place before implementation of any GxP change.

10. Ensuring Quality and Compliance to corresponding standards of following documents:

11. All qualification and instrument life cycle related IT documents.

For example, but not limited to:

• Qualification documents (IQ 33, IQ 13, OQPQ ERES)

• Installation & configuration documents of Chromeleon

• IPC recovery document

• Backup monitoring report

• IPC Retirement document