- The Senior Deviation/Investigation Writer is responsible for performing GxP investigation activities and owning and authoring deviation investigation reports for the Technical Operations (Manufacturing and Packaging) department.
- Requires a Bachelors degree, preferably in a scientific discipline, with a minimum of 3-5 years of experience in a pharmaceutical or related industry.
- Demonstrate a sound understanding of cGMPs, FDA regulations, and pharmaceutical manufacturing/packaging processes.
- Minimum of 3 years manufacturing or technical experience in a regulated GxP environment, oral solid dosage manufacturing/packaging preferred.
- Experience in troubleshooting, investigation, and root-cause/analytical/problem-solving capabilities in a GxP environment.
- Demonstrated, strong technical writing skills with the ability to read, comprehend, and communicate complex, technical events in a manner that is concise, clear and accurate.
- Demonstrated ability to work independently and as part of a collaborative, cross-functional team.
- W orking knowledge of TrackWise or similar deviation management systems
- Perform investigation activities and writing deviation investigation reports for the Technical Operations (Manufacturing and Packaging) department.
- Coordinate prompt event evaluation, investigation, closure and follow-up of process/equipment discrepancies and related areas as well as identify opportunities for continuous process improvements.
- Write concise and accurate investigation reports.
- Utilize various root cause analysis, analytical and problem-solving tools to determine root cause of GxP deviations and assist with the completion of impact analysis and identification of appropriate corrective actions to prevent recurrence.
- Participate in determining the appropriate corrective and preventative actions (CAPAs) after the investigation process.
- Update, author and review standard operating procedures and other controlled documents as a result of process improvements and CAPAs.
- Initiate Change Controls as required for Manufacturing and Packaging operations.
- Collaborate with SMEs from other departments to ensure a cross functional evaluation is completed and ensure alignment of GxP practices.
- Responsible for compliance with Controlled substance documentation and accountability procedures while maintaining high alert to diversion and theft possibilities.
- Perform other related assignments and duties as required and assigned.
- Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching.
- While sitting for an extended period of time on a routine basis, incumbent may use the following equipment: Personal computer, telephone/ other voice communication devices, copier, fax, scanners, or other specialized equipment used in an office setting
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Senior Deviation/Investigation Writer - Wilson, United States - eTeam
Description
Job Title: Senior Deviation/Investigation Writer (Operation)Work Location: Wilson, NC 27893
FTE/Permanent Role (No Relocation Expenses are included)
Range: $70k to $80k per annum
Ability to work a 10 hour per day/4-day work week; 40 hours per week with overtime as required.
Need candidates who have experience writing investigation in Oral Solid Dose (OSD).
Job Summary:
