Quality Assurance

Biocon Biologics

Johor

MYR 30,000 - 60,000

Job description

Updating the trackers and tracking of CAPA & Deviation.
Review of CAPA projects, action implementation plan and effectiveness monitoring plan.
Review evidences and perform closure for CAPA and CAPAEM records.
Data preparation for Review Board Meeting, Management Review Meeting and other meetings as required.
Prepare trending report for CAPA, EVENT.
Facilitate CAPA Review Board Meeting.
Preparation and review of Quality Assurance Standard Operating Procedure.
Participate in external or internal audit, and coordinate external audit responses and compilation of supporting documents for the evidence binder.
Preparation and review of study protocols related to Quality Assurance department.
Impart training on Quality Assurance procedures.
Ensure closure of all QMS elements related.
Review justification for delay (if any) in CAPA closure.
Ensure CAPA is appropriate as per root cause.
Verify the CAPA implementation and effectiveness for closeout.
Review and approval of CAPA plan and timelines.
Track CAPA and CAPA effectiveness check plan with stakeholders to complete CAPA actions on time.
Define CAPA effectiveness check plan in track-wise and assign to applicable stakeholders.
Archive original records.
Initiate any QMS element related.
Review investigation report, impact assessment and closure of deviation report.
Coordinate Investigation Review Board Meeting.
Coordinate and summarize the plant shutdown activity.
Review of event, incident and deviation.
Support other QMS activities depending upon the requirement.
Any other task given by reporting manager from time to time.
Assess the event and issue escalation notification to management and communicate to customer/partner as necessary.