Kaztronix
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Technical Writer
Job Description
Technical Writer Associate
Production Operations
The Technical Writer will perform investigations and assist manufacturing and packaging operations on investigations, Product quality complaints. They will also assist in cross functional investigations for out of specification (OOS), out of trend (OOT), Laboratory Events, CAPAs, and change controls.
Responsibilities:
Education and Job Qualification
Production Operations
The Technical Writer will perform investigations and assist manufacturing and packaging operations on investigations, Product quality complaints. They will also assist in cross functional investigations for out of specification (OOS), out of trend (OOT), Laboratory Events, CAPAs, and change controls.
Responsibilities:
- Ensure timely closure of all manufacturing/packaging and Quality Management System records.
- Organize and participate in reviews of cross functional investigations.
- Represents Operations at cross-functional meetings.
- Work with process owners and SMEs to implement agreed upon procedural documentation and to develop cross-functional process models.
- Collect input from stakeholders and consolidate comments for conflict resolution.
- Drive the improvement in established KPI s / metrics for manufacturing and packaging departments.
- Assist operations in responses to any internal audit, corporate audit, or regulatory audit observations involving manufacturing or packaging control.
Education and Job Qualification
- Associate degree in Life Sciences, Pharmacy, or equivalent required.
- Demonstrated excellent communication: verbal, written and presentation skills.
- A self-starter with a hands-on approach and a can-do attitude.
- A team building champion driving innovative cross functional synergies.
- Excellent project management and problem solving skills.
- Excellent computer skills;MS Office (Word, Excel, PowerPoint), Track wise, EDMS, Outlook.
- Knowledge of GDP, GMP, QA Documentation, QA Batch records, Quality Systems, Archiving, Retrieval, EDMS workflow, Document Life Cycle and Audit Compliance.
- Minimum of three (3) years working in a pharmaceutical environment with at least two (2) years of experience within manufacturing area.
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