Job Description

Ensure compliance to all cGMP, GxP, or any other regulatory requirements, including EHS requirements.
Ensuring compliance and Implementation of all SOPs including Corporate, Site Specific.
Ensure Computer System Software Validation and Maintaining Validated status of all Computerize System Software as per SOPs in line with cGMP guidelines
Identifying gaps in current practice and plan mitigation for each gap as per agreed time-line
Maintain control to ensure that all team members trained on the relevant SOPs and support continuous learning/capability building.
Encourage a culture of quality compliance and open communication that supports all employees to raise quality concerns or suggest improvements.
User Management as site IT administrator
Periodical Audit Trail Review as per SOP and participating in various Internal/External audits.
Manage all Quality applications ( LIMS , Chromeleon , LabSolutions , Tiamo , LCMS etc )

Officer