VALIDATION DEPUTY LEAD [ISKANDAR PUTERI] Full-time Job2 months ago - Swasta - Johor Bahru - 43 views
JD for Validation Deputy Lead
Overall responsible for review and approval of protocols, ensuring process validations, cleaning validations, hold time studies, transport validations and product related validations are planned, executed as per laid down procedures and schedules, review and approval of reports, implementation of recommendations.
Strategic planning and scheduling of activities within team members of Quality Assurance and coordination with cross functional teams to ensure smooth, cGMP and quality compliant manufacturing process.
Responsible for timely closure of summary reports
Responsible for Review of Validation Master plan.
Responsible for continuous process validation
Responsible to lead internal and external audits. The coordination involves liaising with all Head of the Departments during the audits for furnishing the requirements as requested by the auditor(s), to be with the auditor during the audit rounds and meeting, document review as deemed necessary and intimated by reporting authority. Responsible to provide appropriate technical responses during the audit. This also includes convening internal meetings periodically before the audit to review the preparedness as well as meetings during the audit days to understand the possible issues raised during the audit in order to identify and implement appropriate action plan to be presented to the auditor. Identifying, monitoring compliance to CAPA identified as an outcome of audit observations.
Kindly contact Mr Hanafi at 019-7851503 / 07-230 5453 ext 21 email [ email@example.com ] for further details