R&D Quality Assurance Professional

15 hours ago

Hyderabad Secunderabad Telangana, India beBeeQuality Full time ₹ 7,00,000 - ₹ 12,00,000
Job Title:R&D Quality Assurance SpecialistAbout the Role:

This R&D Quality Assurance Specialist position is a unique opportunity to join our team in ensuring the highest standards of quality in analytical and microbiological testing.

The ideal candidate will have extensive experience in quality assurance, with a focus on analytical, microbiology, method verification, and validation within the pharmaceutical, biotech, or life sciences industries.

Key Responsibilities:
  1. Lead the verification and validation of analytical and microbiological methods, ensuring they meet all regulatory and internal quality requirements.
  2. Design, execute, and document method validation protocols, including accuracy, precision, specificity, and robustness studies, in compliance with FDA, TGA, ICH, and EMA guidelines.
  3. Review and approve validation protocols and reports, ensuring they are scientifically sound and fully compliant with Good Laboratory Practice (GLP) and other relevant regulatory standards.
Required Skills and Qualifications:
  • Bachelors degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or a related scientific discipline.
  • Advanced degree (Masters or Ph.D.) in a related field is preferred.
  • Minimum of 5-7 years of experience in quality assurance with a focus on analytical, microbiology, method verification, and validation within the pharmaceutical, biotech, or life sciences industries.
What You'll Gain:
  • Invaluable hands-on experience working alongside seasoned developers.
  • Opportunity to learn and grow in a supportive environment.
  • Gain exposure to the entire software development lifecycle.
Additional Requirements:
  • Extensive experience with analytical and microbiological testing methods, including method verification, validation, sterility, microbial limits, and endotoxin testing.
  • Strong expertise in analytical and microbiological methods and their application in product development.
  • Excellent attention to detail and analytical skills with a focus on data integrity and accuracy.
  • Strong written and verbal communication skills, with the ability to document and present complex technical information clearly.
  • Ability to work effectively in a team-oriented environment and collaborate across multiple departments.
  • Proficiency with quality management systems and software tools.

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