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