Specialist / Associate Manager - MS&T (Investigation and Deviation management)
On-siteHyderabad, Telangana, India
Job Summary
Lead and support complex investigations and deviation management activities for biologics manufacturing processes, products, and equipment. Apply structured Root Cause Analysis methodologies, including 5 Whys and Fishbone Diagrams, to identify issues and implement Corrective and Preventive Actions. Conduct quality risk assessments using QRM frameworks, author investigation reports, and ensure compliance with cGMP, SOPs, and regulatory guidelines. Collaborate with cross-functional teams to drive improvements in quality, productivity, and efficiency while supporting validation, manufacturing operations, and inspection readiness. This role requires a Bachelor's degree in a science stream and 5-12 years of experience in MS&T or Quality Assurance within the Large Molecules platform. Candidates must demonstrate proficiency in deviation handling, CAPA management, and risk assessment.
Required Qualifications
- Bachelor's degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biomedical engineering, Biotechnology, Chemistry, or equivalent science streams
- 5-12 years of experience in MS&T, Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substance in Large Molecules platform/facility (Biologics/Biosimilar)
- Proficient knowledge on deviation handling, incident investigations, root cause analysis, CAPA management, risk assessment and risk management programs
- Familiar with regulatory guidance on validation, product filing and post approval changes
- Basic knowledge of statistical analysis, results interpretation, and usage of statistical tools (Example: Minitab, Statistica etc.)
- Good communication, presentation and interpersonal skills
Desired Qualifications
- Desirable MSc/MS. or equivalent experience
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