Job Details
Experience Needed:
Career Level:
Education Level:
Salary:
Job Categories:
Skills And Tools:
Job Description
Main Job Duties:
- Author/Review/Execute process validation protocols and summary reports.
- Perform validation testing and analyze data for validation documentation to determine acceptability, identify deviations and make appropriate notification.
- Review/assess proposed changes to validated processes via CAPA, Change Control and Work Orders to identify requirements necessary to maintain validated status.
- Production oversight during validation events.
- Work to ensure validation documentation becomes part of the site’s GMP documentation database.
- Review the manufacturing batch records before its issuing.
- Lead in the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards.
Job Requirements
- Bachelor's Degree in pharmaceutical Sciences.
- Must have 2 to 3 years of experience in validation department with an in-depth knowledge of preparing and implementing process validation protocols and authoring validation summary reports.
- Knowledge of current Good Manufacturing Practices, Quality System regulations, and ISO standards.
- Problem-solving and troubleshooting skill.
- Attentive to Detail: Ensure information is complete and accurate; follow up with others to ensure that agreements and commitments have been fulfilled.
- Ability to work independently.
- Strong verbal and written communication skills.