Officer/ Senior Officer- QA-Qualification

Gracure Pharmaceuticals Ltd.

Bhiwadi

On-site

INR 300,000 - 600,000

Full time

6 days ago
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Job summary

Gracure Pharmaceuticals Ltd. in India is seeking a QA/Validation professional with experience in OSD.

The role focuses on batch manufacturing records, qualification protocol documentation, and media fill/APS validation, along with comprehensive validation activities and risk assessment to ensure systems meet predefined acceptance criteria. The candidate should have at least 1 year of experience in Qualification & Validation and must be familiar with OSD environments to contribute effectively to

Qualifications

  • 1+ year of experience in Qualification & Validation.
  • Experience with OSD is required.

Responsibilities

  • Batch Manufacturing Records documentation.
  • Documentation of Qualification protocols and reports.
  • Media Fill / APS validation.
  • Validation activities including review and assessment of system performance against predefined acceptance criteria.
  • Risk Assessment.

Skills

Qualification & Validation
Documentation

Job description

Role & responsibilities
  • Batch Manufacturing Records
  • Documentation of Qualification protocols and reports
  • Media Fill / Aseptic Process Simulation (APS) validation
  • Validation activities, including review and assessment of system performance against predefined acceptance criteria
  • Risk Assessment
Preferred candidate profile
  • Must have worked for OSD
  • Atleast with 1 year of experience in Qualification & Validation.
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