Jamp Pharma Hiring For QA Dept

Jamp Pharma Hiring For QA Dept

Jamp Pharma Hiring For QA Dept
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 atsjani@jamppharma.com

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