Location: Regional, Poland
Closing Date: 07 Dec 16
Salary (£): Competitive
COVANCE POLAND - we are currently seeking to hire an EDC Validation Coordinator This is a permanent, full time, office based position in Warsaw http://jobsearch.covance.com/jobs/1421872-EDC-Validation-Coordinator.aspx
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
We are currently seeking to hire a EDC Validation Coordinator. This is a full time position based in the Warsaw office. This is a permanent, full time, office based position.
Within this position, your duties will include:
- Leading validation projects as assigned and serve as a validation team member on multiple assignments as designated by the management with support from other team members as needed.
- Reviewing EDC specifications.
- Writing and assembling critical validation documentation packages including the Validation Plan, Testing Results, Traceability Matrix, and Validation Report.
- Providing coordination of virtual global validation teams as needed to complete validation projects.
- Maintaining and utilising a strong knowledge of SOPs and validation work procedures/standards in relation to the System Development Life Cycle.
- Executing test cases against these requirements, enter errors in to error tracking logs and performing retests, documenting resolutions, and maintaining validation testing documentation and files.
Bachelor's degree preferably in the sciences or related field.
- Experience of working within the pharmaceutical industry
- Validation Experience or work Experience in a regulated (FDA, EPA, etc.) environment preferred
- Strong attention to detail
- Strong analytical skills, preferably in a GCP environment
- Experience with 21 CFR Part 11 in a pharmaceutical, biotechnology, CRO or related industry
- Problem Solving/Logic Skills
- Strong communication and interpersonal skills
- Strong MS/Office skills in particular with Excel and Word
- Understanding of Electronic Data Capture (EDC) and the clinical trial process preferred
EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.
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