Job description
Pharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for more than 28 years. Since our inception, our services have resulted in a project experience level and personnel resource base ranking among the highest worldwide.
Currently, we are gathering a pool talent for future CSV opportunity to provide services within the North East Region of USA (Atlanta, Ohio, North Carolina, Florida). Preferably on-site availability.
Duties may include:
- Previous experience working with C&Q and Automation.
- Develop, update, review, approve and maintain qualification test protocols (IQ, OQ and PQ) and data migration protocols..
- Develop, update, review, approve and maintain summary reports and requirement traceability matrix.
- Review planned and unplanned changes (configuration updates, system enhancements, operating system updates, application updates, etc.) and assess validation impact.
- Perform risk assessment of proposed changes to determine scope of validation/re-validation.
- Other duties related.
Requirements:
- Bachelor’s Degree in Science.
- 3-5 years CSV experience in a regulated (pharmaceutical/medical device industry) environment.
- Preferably with Veeva and TrackWise validation experience with relevant 21 CFR Part 11 & 211, ICH E6(R2) & ICH Q9.
- Demonstrated experience and excellent knowledge of applicable CSV and other applicable regulations GMP guidance.
Job Types: Full-time, Contract, Temporary
Salary: $1.00 per hour
Experience level:
- 3 years
Schedule:
- 8 hour shift
Ability to commute/relocate:
- North Carolina: Reliably commute or planning to relocate before starting work (Required)
Application Question(s):
- Are you available to consider job opportunities in states like Atlanta, NJ, NC, Florida, Ohio, within the NE areas of United States?
Work Location: In person
caravetterealestate.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, caravetterealestate.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, caravetterealestate.com is the ideal place to find your next job.