MBU Analytics Product Marketing Manager jobs are vacant in Bend,OR. The ProPharma Group it's specialized into Business Operations industry. Currently the headquarters are in Oregon.
MBU Analytics Product Marketing Manager job positions are vacant on ProPharma Group company, located in Bend with a rate of $21-79/hour.
More details about the job listing:
ProPharma Group is an industry leading single source provider for regulatory compliance pharmacovigilance and medical information services across the full development lifecycle for pharmaceutical biotechnology and medical device companies. Operating around the world with offices in Australia Canada Germany Japan the Netherlands Sweden United Kingdom and the United States ProPharma Group s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today s dynamic markets. We build successful long term relationships with clients by providing leading industry knowledge experience and proven processes.
Our client is looking for a Senior Computer Systems Validation Consultant for a 6 month engagement at their Bend Oregon facility. Initial 3 months would be remote document generation with the following 3 months being on site execution. Duties and responsibilities to include but are not limited to:
Essential Functions Include:
Perform Enterprise System CSV lifecycle documentation. Perform MFG and QC Instrument ERES Part 11 lifecycle documentation. Obtain specific assignments from ProPharma Group or client Project Manager. Ensure individual activities are clearly communicated and documented to Project Manager. Execute basic qualification protocols IQ OQ PQ document deviations and develop traceability matrices. Review assigned protocols prior to execution. Perform technical writing and communicate clearly on all technical business and professional interpersonal levels of the organization. Apply Computer System Validation experience as it relates to GxP regulated business processes. Attend and contribute to scheduled Practice meetings. Participate in company programs such as Project Management Quality Social Responsibility Wellness Safety and Training. Create annual personal goals and development plan with administrative manager. Assist with interviews of ProPharma Group candidates. Extensive travel required. Other duties as assigned.
Qualified candidates must have:
B.S. B.A. in Engineering Science Information Technology or related field. Three years of relevant work experience may be substituted in lieu of education. Minimum of 10 years of experience in the field of Computer System Validation. Minimum of 10 years of experience in related Pharmaceutical or Healthcare Industries. Experience in the validation of at least one computer system category: automation control laboratory systems quality workflow ERP clinical data. Possess effective written and oral communication skills ability to write type express or exchange ideas of a technical nature by means of the spoken word convey information instructions accurately receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks. General business math skills. Working knowledge of Microsoft Word Microsoft Excel and other word processing programs as may be required by the position PowerPoint Access and Microsoft Project may be required including but not limited to Visio. Ability to walk stand and move about for long periods of time work with equipment in the field read prepare and analyze data for development of reports ability to sit and type for long periods of time ability to read and assemble documents as required. Basic knowledge of FDA GxPs FDA Guidelines and European Guidelines where applicable and other regulatory requirements. Basic knowledge of industry best practice such as GAMP5 ANSI standards S 95 S 88 and ASTM E2500 . Basic knowledge of 21 CFR 11 including ERES predicate rule and legacy system requirements.
All candidates must be legally eligible to work in the United States. We are an equal opportunity employer. M F D V
***ProPharma Group does not accept unsolicited resumes from recruiters third parties. Please no phone calls or emails to anyone regarding this posting.***