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Description supplied by the original job listing.
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
2 - 4 Years
Employment type
P-P7-Probationer-HO Staff
Work arrangement
No
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