Sr Officer, QC Technical Writer
Amneal Pharmaceuticals · Ahmedabad · onsite · Posted 42d ago
Undisclosed2–7 yrsfulltimeSourced from
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About this role
- Prepare Stability Summary Reports (SSR) and related stability documentation.
- Track stability study status, report timelines, and documentation activities.
- Maintain stability records, reports, and supporting documents in an organized manner.
- Review stability data and documentation for completeness and accuracy.
- Coordinate with QC, QA, and cross-functional teams for data collection, review, and approval of SSRs.
- Ensure timely updates, document revisions, and archival of stability documents.
- Maintain documentation compliance as per GMP, GDP, and regulatory requirements.
- Support audit and inspection requirements by providing stability documentation and records.
Required Skills:
- Stability Documentation SSR Preparation - Ability to prepare accurate and compliant Stability Summary Reports.
- Document Tracking Record Management - Strong skills in maintaining and monitoring stability documentation status.
- GMP/GDP Documentation Practices - Understanding of regulated documentation requirements.
- Data Review Accuracy - Ability to verify stability data and ensure completeness of reports.
- Coordination Timeline Management - Effective follow-up with teams to ensure timely completion of stability documents.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
FramemakerTechnical EditingsnagitDITARoboHelpInspectiontechnical writingContent EditingTechnical DocumentationContent DevelopmentddlcQuality AssuranceContent WritingDocumentationRecords ManagementProof Reading
About Amneal Pharmaceuticals
Amneal Pharmaceuticals
Pharma
5.5k+
employees
2002
24 years old
Bridgewater, New Jersey
United States (USA)
About
Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.
Industries
PharmaBiotechnologyClinical Research
Employee ratings
1,455 reviews
4.2/ 5
Culture
4.0
Career growth
3.5
Work-life
4.2
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