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

- Robust 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.

Job Snapshot

Updated Date

14-09-2026

Job ID

JOB11077

Division

SIKKIM FORMULATION II

Location

Zhl - Sikkim|zhl-sikkim Plt., Gangtok, Sikkim, India

Experience

2 - 4 Years

Employee Type

P-P7-Probationer-HO Staff

📌 MS&T (Mfg. Investigator) @Sikkim II (India)
🏢 Zydus Group
📍 India