Job Location: Bangalore, India
- Leads 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.
- Review EDC specifications from Lead Data Manager.
- Writes and assembles critical validation documentation packages including the Validation Plan, Testing Results, Traceability Matrix, and Validation Report.
- Provide coordination of virtual global validation teams as needed to complete validation projects.
- Maintains and utilizes a strong knowledge of SOPS and validation work procedures/standards in relation to the System Development Life Cycle.
- Executes test cases against these requirements, enter errors in to error tracking logs and performs retests documenting resolutions, and maintain validation testing documentation and files.
- BS/BA degree preferably in the sciences or related field, or 5.5 years in a validation or regulatory position dealing with SOPS and computer systems requirement specification.
- Minimum 5.5 to 8 years of pharmaceutical or equivalent experience.
- 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.
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