Medical Documentalist Pharmaceutical Company
5 days ago
We are a fast-growing and successful agency that treats all its clients and candidates with a personal touch. Our mission is to bring the right people to the right job every time, bettering people's lives and increasing our customers and employees' success.
Job Overview:
As a skilled Pharmaceutical Technical Writer, you will play a key role in our team's success. You will be responsible for performing investigations and assisting manufacturing and packaging operations on investigations, Product quality complaints. You 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 investigation's
- Represent 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.
Required Qualifications:
- Associate degree in Life Sciences, Pharmacy, or equivalent required.
- Minimum of three years working in a pharmaceutical environment with at least two years of experience within manufacturing area.
- 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), Trackwise, EDMS, Outlook.
- Knowledge of GDP, GMP, QA Documentation, QA Batch records, Quality Systems, Archiving, Retrieval, EDMS workflow, Document Life Cycle, and Audit Compliance.
- The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).
Why Choose Us:
We offer a competitive compensation package as well as an excellent benefits package for eligible candidates, including health insurance, 401(k) matching, and paid time off.
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