Executive, Technical Writing
Executive, Technical Writing
Amneal Pharmaceuticals5-8 Years
- Posted 13 hours ago
- Be among the first 10 applicants
Job Description
Essential Functions
JOB DESCRIPTION
QUALIFICATIONS
JOB DESCRIPTION
- Prepare, develop, and maintain technical documents including standard operating procedures, work instructions, technical reports, and related materials in compliance with cGMP and regulatory requirements
- Conduct periodic document audits to ensure ongoing compliance, traceability, and alignment with evolving regulatory requirements
- Collaborate with manufacturing, quality, regulatory, and engineering teams to gather technical information and translate it into clear, compliant documentation
- Review existing documentation to identify gaps, inconsistencies, or areas requiring update and escalate findings to relevant stakeholders
- Ensure all technical documents accurately reflect manufacturing processes, equipment operations, and quality systems
- Support the document control lifecycle including creation, revision, review, approval, and archival of technical documents
- Maintain accurate and complete documentation records including document revision histories and change control logs
- Ensure all technical writing activities comply with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements
- Participate in process improvement projects and functional team initiatives to enhance documentation quality, efficiency, and compliance
- Support training activities related to technical documentation standards and cGMP requirements as required.
QUALIFICATIONS
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 5 years or more in 5 - 8 Years
More Info
About Company
Skills:
training programs , packaging operations, bottle filling, Sops, Cgmp, master records, track trace systems, equipment qualifications, blister lines, batch documentation, Capa, ERP transactions, Continuous Improvement, labeling, URS qualification protocols, Validations, commercial process validation, CVC lines, performance qualification records
Skills:
Microsoft Office, Shipment Processing Transit Management, Operational MIS Performance Analytics, Service Quality Operational Excellence, Process Improvement Productivity Enhancement, Network Planning Schedule Adherence, Logistics Management Systems, Air Surface Network Operations, Safety Security Regulatory Compliance, Hub Mid Mile Operations Management, Fleet Coordination Capacity Utilisation
Skills:
Validation Protocols, Qualification Techniques, Regulatory Compliance, Risk Assessment, Data Analysis, Technical Writing
Skills:
Gap Analysis, Clinical Quality Assurance for medical-device clinical investigations, Non-conformity tracking, CAPA management, Knowledge of ISO 14155, Clinical documentation traceability, Cross-functional coordination, Audit readiness, Document Control, QA checklist development
Skills:
SAP BRIM, Data Migration, Solution Design, Technical Documentation, FICO Integration, Billing Management, revenue recognition, Project Management, Analytical Skills, Client Engagement