Senior Quality Assurance Specialist

1 day ago

Hyderabad Secunderabad Telangana, India beBeeQualityAssurance Full time

Job Title: Quality Assurance Specialist

Job Description:

The primary objective of this role is to ensure the quality and integrity of pharmaceutical products by implementing effective quality risk management frameworks, conducting thorough investigations, and providing expert technical support.

This position requires a comprehensive understanding of quality risk management principles, investigational techniques, and regulatory guidelines. The ideal candidate will possess excellent analytical and problem-solving skills, with the ability to interpret data and make informed decisions.

In addition to these core competencies, the successful candidate will have hands-on experience with structured RCA methodologies, such as impact assessment, Fish bone diagram, 5 whys, Timeline & process mapping, and proficiency in using statistical analysis tools like Minitab.

Required Skills and Qualifications:
  • Bachelor's degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biomedical engineering, Biotechnology, Chemistry, or equivalent science streams.
  • Minimum 5 years of experience in MS&T, Quality Assurance, Regulatory, or manufacturing of pharmaceutical drug substance or drug products in Sterile/Large Molecules platform/facility.
  • Proficient knowledge on deviation handling, incident investigations, root cause analysis, and CAPA management.
  • Familiarity with regulatory guidance on validation, product filing, and post-approval changes.
Benefits:
  • Opportunity to work in a dynamic and collaborative environment.
  • Professional growth and development through training and mentoring programs.
  • Competitive salary and benefits package.
Others:

We offer a diverse and inclusive workplace culture that values creativity, innovation, and teamwork. If you are passionate about quality assurance and have a strong desire to make a difference in the pharmaceutical industry, we encourage you to apply for this exciting opportunity.

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