Jamp Pharma Hiring For QA Dept
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Jamp Pharma Hiring For QA Dept |
Dept: Quality Assurance -Complaints
Position: Senior Executive / Assistant Manager
Experience: 4 - 8 years
Qualification: B. Pharma / M. Pharma
Location: Ahmedabad
Job Role:
- Evaluates new market complaints daily and communicates them to the various manufacturing
- partners, determines the criticality of complaints and makes appropriate recommendations.
- Escalates critical complaints and those with the potential to affect an entire batch or multiple
- batches.
- Conducts risk assessments for quality complaints, sampling to determine the percentage of
- products affected by complaints (AQL), if required.
- Reviews batch release records involved in quality complaints to document relevant information
- in complaint reports.
- Examines retained and complaint samples and documents observations in the complaint report.
- Conducts internal investigations for complaints not related to product manufacturing or
- packaging.
- Sends complaint samples to manufacturing partners and follows up on investigation requests
- with manufacturing partners.
- Evaluates investigation reports received from manufacturers and requests additional
- explanations when necessary, completes complaint reports and proposes preventive and/or
- corrective actions (CAPA), if applicable and analyzes complaint trends and escalates information
- as required.
- Keeps the complaint tracking system up to date and ensures justified extension requests are
- made before deadlines.
- Ensures the timely closure of complaints and CAPAs, develops and maintains key performance
- indicators (KPIs) for the complaints and CAPA sector to provide support for investigations, as
- needed. Promotes quality on a daily basis
Send profile at: sjani@jamppharma.com
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