Quality Assurance Specialist

6 days ago

Hyderabad Secunderabad Telangana, India beBeeInvestigation Full time ₹ 15,00,000 - ₹ 28,00,000

Our organization seeks a highly skilled professional to fill the role of Quality Assurance Specialist. This is an exciting opportunity for a motivated individual who is passionate about ensuring the highest quality standards in pharmaceutical manufacturing.

Key Responsibilities:

  • The ideal candidate will have comprehensive knowledge and experience in using Quality Risk Management frameworks, as well as excellent report writing skills.
  • Hands-on experience with structured RCA methodologies, including impact assessment, Fish bone diagram, 5 whys, and process mapping, is essential.
  • The candidate should have a strong background in handling investigations and deviations related to Process (Upstream/Downstream), Product, and Equipment.
  • A thorough understanding of core manufacturing unit operations, such as sampling, monitoring, and continuous process support, is required.
  • Experience working in GxP environments and handling procedural requirements for HA audits is also necessary.
  • The successful candidate will be responsible for offering technical and scientific expertise to address process-specific matters, ensuring compliance with cGMPs, SOPs, and relevant guidelines and functional standards.
  • Prior experience of handling internal and health authority audits and inspections is preferred.
  • Ensuring overall inspection readiness for the area of responsibility and reporting technical complaints/adverse events/special case scenarios within 24 hours of receipt is a must.
  • Certification in investigation handling-Root cause analysis (RCA) is preferred.

Essential Qualifications:

  • Bachelor's degree in Pharmacy, Pharmaceutical Technology, Chemical Engineering, Biomedical Engineering, Biotechnology, Chemistry, or equivalent science streams is required.
  • Desirable MSc/MS or equivalent experience.
  • Minimum 5 years of experience in MS&T, Quality Assurance, Regulatory, or in the manufacturing of pharmaceutical drug substance or drug products in Sterile/Large Molecules platform/facility.
  • Minimum of 5 years of pharmaceutical process validation and cleaning validation.
  • Familiarity with basic statistical evaluations using Minitab or other statistical analysis tools.
  • Proficient knowledge on deviation handling, incident investigations, root cause analysis, and CAPA management.
  • Knowledge of risk assessment and risk management programs.
  • Familiarity with regulatory guidance on validation, product filing, and post-approval changes.
  • Basic knowledge of statistical analysis, results interpretation, and usage of statistical tools.
  • Good communication, presentation, and interpersonal skills.

Benefits:

  • Opportunity to work in a dynamic and challenging environment.
  • Professional growth and development opportunities.
  • Competitive compensation package.
  • Excellent benefits, including medical, dental, and vision insurance.

Other Requirements:

  • Bachelor's degree in pharmacy, pharmaceutical technology, chemical engineering, biomedical engineering, biotechnology, chemistry, or equivalent science streams is desirable.

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