R&D Assurance Specialist

1 week ago

Hyderabad Secunderabad Telangana, India beBeeQuality Full time ₹ 1,04,000 - ₹ 1,30,878
Job Description

This position involves overseeing the validation and verification of analytical and microbiological methods to ensure they meet all regulatory and quality requirements.

The professional will design, execute, and document method validation protocols, including accuracy, precision, specificity, and robustness studies, in compliance with FDA, TGA, ICH, and EMA guidelines.

They will 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.

Responsibilities:

  • Lead the verification and validation of analytical and microbiological methods.
  • Design, execute, and document method validation protocols.
  • Review and approve validation protocols and reports.
Required Skills and Qualifications

The ideal candidate will have a Bachelor's degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or a related scientific discipline. An advanced degree (Masters or Ph.D.) in a related field is preferred.

Minimum 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.

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.

Benefits

This role offers invaluable hands-on experience working alongside seasoned professionals.

Opportunity to learn and grow in a supportive environment.

Gain exposure to the entire software development lifecycle.

Contribute to real-world software projects and make a positive impact.

Others

This position is remote and may require occasional travel to other sites or meetings.

The role may involve working in a laboratory environment with exposure to chemicals and biohazardous materials.

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