TECH WRITER - OQSIE
Irvine, CA
About the Job
arry out validation activities for manufacturing processes, which include equipment qualifications, process qualifications, software validations, process capability studies, and process improvements.
Engage with clients, scope requirements and support projects in the following areas
Create and execute validation protocols
Create and execute URS, IQ, OQ, PQ, TMV, Risk assessments
Review data and generate reports
Review and implement international test standard
Skills and Education
Education: BS/MS degree in a health and life sciences related fields, preferably Pharmaceutical Science, Regulatory Science, Biology, Chemistry, microbiology, biochemistry.
Demonstrated problem-solving and troubleshooting skills
Demonstrated good interpersonal and written communication skills
Demonstrated results orientation, team skills, ability to multitask, ability to learn quickly and the ability to respond to urgent needs of the team and deliver expected results within expected deadlines
Demonstrated ability to serve as a technical resource for assessing validation requirements and solving test related problems
Demonstrated proficiency in standard office software, including Word, Excel, Project, and PowerPoint
Engage with clients, scope requirements and support projects in the following areas
Create and execute validation protocols
Create and execute URS, IQ, OQ, PQ, TMV, Risk assessments
Review data and generate reports
Review and implement international test standard
Skills and Education
Education: BS/MS degree in a health and life sciences related fields, preferably Pharmaceutical Science, Regulatory Science, Biology, Chemistry, microbiology, biochemistry.
Demonstrated problem-solving and troubleshooting skills
Demonstrated good interpersonal and written communication skills
Demonstrated results orientation, team skills, ability to multitask, ability to learn quickly and the ability to respond to urgent needs of the team and deliver expected results within expected deadlines
Demonstrated ability to serve as a technical resource for assessing validation requirements and solving test related problems
Demonstrated proficiency in standard office software, including Word, Excel, Project, and PowerPoint
Source : OQSIE