MS&T (Mfg. Investigator) @Sikkim II

Company Name: Zydus Healthcare Limited
Industry: Pharmaceuticals
Website:  https://www.zyduslife.com/zyduslife/
Location: Sikkim Unit II
Position: Officer
Department: MS&T (Manufacturing Science & Technology)
Role: Manufacturing Investigator
Qualification: B.Pharma / M.Pharma
Experience: 02 to 04 Years

Key Responsibilities

• Handle Quality Events such as Out of Specification (OOS) and Out of Trend (OOT) investigations for the manufacturing facility.
• Execute Phase-II manufacturing investigations related to all applicable manufacturing unit operations.
• Review Phase-I analytical investigation reports to understand the nature and impact of failures.
• Perform Root Cause Analysis (RCA) for OOS/OOT events associated with solid dosage forms.
• Collect, review, and document all relevant investigation data to support scientific conclusions.
• Review Batch Manufacturing Records (BMR), Packing Records, analytical data, stability data, process development reports, engineering batch data, OPV reports, risk assessments, and technology transfer documents.
• Prepare comprehensive investigation reports with appropriate supporting evidence and data.
• Coordinate with Production, QA, QC, Engineering, and other cross-functional teams for implementation and effectiveness monitoring of CAPAs.
• Ensure compliance with cGMP, GDP, Data Integrity, and regulatory requirements during all investigations.
• Execute trend analysis of Critical Material Attributes (CMAs), Critical Process Parameters (CPPs), and Critical Quality Attributes (CQAs) using appropriate statistical tools.
• Attend mandatory SOP and job-related training programs and contribute to continuous self-development.
• Follow company policies, procedures, and quality standards applicable across all manufacturing sites.

Required Skills

• OOS/OOT Investigation Management
• Root Cause Analysis (RCA)
• CAPA Management
• cGMP & GDP Compliance
• Statistical Data Analysis and Trending
• Investigation Report Writing
• Quality Risk Assessment
• Strong Analytical and Problem-Solving Skills
• Cross-Functional Coordination
• Knowledge of Data Integrity and Regulatory Expectations

Interested candidates may apply through the Internal Job Posting (IJP) Portal or Careers Page.

• Experience: 0+ years
• Seniority: No Prior Experience Required
• Education: Bachelor's degree required
• Languages: English