Senior Executive, QMS (QA)
Amneal India · Ahmedabad, Gujarat, India
Pharmaceutical Manufacturing · 5,001-10,000 employees
9 h ago
Senior (5-10 yrs)
Full-time
India
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About the role
The Senior Executive is responsible for managing the Quality Management System (QMS) to ensure compliance with cGMP standards. This includes overseeing deviations, CAPA management, vendor qualifications, and the preparation of Annual Product Quality Reviews.
What they look for
Quality Management System
cGMP
CAPA Management
SOP Review
Vendor Qualification
Compliance Risk Assessment
Deviation Handling
OOS Investigation
OOT Investigation
Change Control
Self-Inspection
APQR Preparation
Product Recall
Regulatory Compliance
Quality Assurance
Requirements
Candidates must hold a B. Pharm or M. Pharm degree and possess 5 to 8 years of relevant experience in quality assurance. Strong knowledge of regulatory compliance and quality event management is required for this role.
Full description
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
