Description:
Managing overall activity of QMS. Establishing and implementing quality
systems to comply cGMP. Handling of Product Complaint, Deviation, OOS (Out of
Specification), OOT (Out of Trend), Incident and Change Control.
CAPA management, tracking, verification of implemented CAPA from CCN,
Deviation, OOS, Self-Inspection and Market complaint.
Review of SOPs, Instrument operating procedure, standard test procedure,
effective implementation of SOP.
Handling of Self-Inspection.
Annual Product Quality Review (APQR/APR) preparation and review, trending of
quality parameter.
Handling of Recall and Investigation of the same.
Develop and execute risk assessments and reviews of compliance risk areas to
determine need for improvement often in consultation and coordination with
internal and external audit groups.
Vendor Qualification: Handling the Vendor Qualification and Re-approval audit
for RM (Raw Material), PPM (Primary Packaging Material), SPM (Secondary
Packaging Material), Contract analysis laboratory and Contract services

📌 Senior Executive, Qms Ahmedabad
🏢 Amneal India
📍 Ahmedabad