Senior Executive - Quality Assurance

Alere Medical
3-5 Yrs
Gurgaon
Not Disclosed By Recruiter
B.Pharma/B.Sc
Quality Assurance, Validation. QMS, Documentation, IPQA, Capa, ISO 13485, Design, Process Capability

Posted By : Shalini Jaitly, 09/05/2016

Alere Medical Pvt Ltd

Alere delivers reliable and actionable information through rapid diagnostic tests, resulting in better clinical and economic healthcare outcomes globally.

Alere is committed to delivering high-quality products and services that patients and providers can rely on for consistently accurate and actionable information. We deploy unique innovative technologies that not only transform diagnostic products, but also expand into new platforms and solutions with proven health and economic outcomes.

Job Description

  • Perform role of Quality Coordinator for Quality Incidents, CAPA and Change Management in electronic system (Agile-PLM).
  • Candidate will be responsible for initiation, monitoring and timely closure of Quality elements (Quality Incident/CAPA/Change Orders) in Agile.
  • Ensure compliance in accordance to organizational Quality Standard and Regulatory requirement.
  • Responsible for periodic Trend preparation and follow ups of Quality elements and Presenting Quality data in monthly meetings.
  • Batch Record Review and Finished Goods Releases.

Job Requirement

  • Must have Knowledge of current GxP regulations, Drug and Cosmetics Act - 1940 and related QMS aspects of ISO 9001 and ISO 13485.
  • Should have experience on Quality Tools (Process Mapping, Risk Analysis, Cause & Effect Diagrams, Pareto Analysis, etc.).
  • Good knowledge of MS office(excel, power point, word).
  • Knowledge of IT GxP requirements such CSV and GAMP-5 standard.
  • Excellent verbal and written English communication skills.

Interested candidates can send their resume at manoj.bhoj@alere.com

Industry :

Medical Healthcare and Hospital

Job Function :

Senior Executive - Quality Assurance

Employment Type :

Full Time

Other Skills :

Quality Assurance, Validation. QMS, Documentation, IPQA, Capa, ISO 13485, Design, Process Capability

Company Name :

Alere Medical

Company Address :

Gurgaon

Click here to see Contact Details

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