Validation Specialist

Top Required skills:

• Minimum Bachelor’s degree
• W2 Only (they want to convert)
• Validation / QA experience in pharma, healthcare environment
• Testing experience
• Experience validating systems for FDA regulations (CFR, CGMP, FDA, etc.)
• Experience working in SAP environment (specifically with Data Stewardship Platform)

Disqualifiers:

• No bachelors degree
• Corp candidates
• No validation / QA exp within pharma, healthcare
• No testing exp
• No experience working in SAP environment

Top 3 Skills:

• SAP Testing
• Backoffice Associate Applications - Data Stewardship Platform (DSP)
• SAP: Customer, Material, Vendor, and Finance Master Data desired
• Daily job responsibilities they vary but overall:
• Validating that products being developed meet FDA requirements
• Lead or participate in various software lifecycle (SLC) deliverables
• reviews Risk analyses and other software quality assurance activities with primary focus on review and approval of validation test scripts and incident reports for compliance with Operating Procedures, FDA requirements and the CFR including 21 CFR Part 11.

JOB DESCRIPTION:
5-10 years exp in the following

Responsibilities:

• The candidate is responsible for all software quality assurance activities such as
  • evaluation of software lifecycle (SLC) deliverables for compliance with Operating Procedures
  • FDA requirements and the CFR including 21 CFR Part 11.
• Lead or participate in various reviews, risk analyses and other software quality assurance activities with primary focus on review and approval of validation test scripts and incident reports.
• Have a background in software engineering, software lifecycle activities, or software validation and be familiar with the work products that result from SLC key activities.
• Knowledge or experience in requirements gathering, analysis techniques, software verification/validation techniques, configuration management techniques or documentation standards.
• The candidate should be familiar with IEEE, SEI, ISO and have experience in a regulated environment.
• Analytical skills are important, as is the ability to manage tasks.
• Must be able to manage multiple tasks and resources.
• Defines and tracks quality assurance metrics.
• Good verbal and written communication skills.
• Knowledge or experience in SAP testing and HP ALM Quality Center preferred. 

Preferred skillsets:

• Knowledge or experience in SAP testing and HP ALM Quality Center preferred.

Required skillsets:

• Experience working with software lifecycle deliverables and ability to incorporate updates to meet the needs of the business and project teams
• Effective time management and ability to adjust workload to meet customer needs
• Good interpersonal skills with the ability to work collaboratively with multiple project teams of differing backgrounds
• Must be able to work 50 weeks out of the year, excluding holiday