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Sr Executive / Assistant Manager - QA (IVD)

Sr Executive / Assistant Manager - QA (IVD)

Promea Therapeutics
Early Applicant
  • Posted 2 months ago
  • Be among the first 30 applicants

Job Description

  • Responsible for implementation of cGMP in the plant.
  • Responsible for review of SOPs.
  • Responsible for preparation of Quality Documents such as SMF, Quality Policy etc.
  • Responsible for review and compilation of Deviations, Incidents, Change Control and Root Cause Analysis.
  • Responsible for review and proper implementation of CAPA.
  • Responsible for conducting and preparation of Self-inspection reports.
  • Responsible for handling of Market Complaints & Product Recall.
  • Responsible for providing trainings.
  • Responsible for approval of Certificate of Analysis, Specifications, STPs and SOPs.
  • Responsible for review of approved vendor list of Raw Material & Packing Material.
  • Responsible for review of Master Packing Card, Master Formula Card, Batch Manufacturing Records & Batch Packing Records.
  • Responsible for ensuring the Design and development processes meet regulatory and quality standards.
  • Responsible for risk management associated with IVD products.

More Info

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Industry:
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Key Skills

STPs

Master Formula Card

Product Recall

Quality Documents

Batch Packing Records

Certificate of Analysis

Incidents

Market Complaints

Self-inspection reports

Specifications

quality standards

Master Packing Card

IVD products

Batch Manufacturing Records

About Company