QA Validation Lead - GxPs, GAMP5

8 - 10 years experience  • 

Salary depends on experience
Posted on 04/18/18
Boston, MA
8 - 10 years experience
Salary depends on experience
Posted on 04/18/18

Position Description:

• Senior Consultant with 8+ years of validation experience on premise - 5 days a week

• Familiar with Agile/Scrum/Sprint methodology

• Comes from a Pharma background and understands core competencies of Validation

• Can guide, coach and lead validation team onsite and off site team

Your future duties and responsibilities:

Task include: script execution, script review and approval

• Sprints come in groups; client requires just-in-time testing

• Several projects managed concurrently: vSMART, ARGUS, SAS, TrackWise, QDOCS, eTMF, Please Review, EDMS, LMS, etc.

• Ensures quality and completeness of work

• Can adapt team to work on different applications and become more of generalists

• Needs to work collaboratively with Quality•

Required qualifications to be successful in this role:

• Validation experience on premise and in cloud

• Good Communications skills with team and with client

• Ability to extract requirements and manage large teams

• Methodology – Waterfall, Agile, Scrum, Hybrid

• Risk-base approach: GxPs, GAMP5

• Concepts: IQ, OQ, PQ for Clinical, Quality and PQR

• Ability to apply client’s validation methodology: configuration verification, UAT testing, User functionality, COTS

NONESSENTIAL SKILLS DESIRED

• Business acumen

• Proactive

• Willing to learn

• SOPs

• Quality assurance

• Assist team with support

• Recommend new ways to approach validation – electronic execution

HARDWARE/SOFTWARE PACKAGES

• Clinical, Quality and PQR systems

EDUCATION REQUIREMENTS

• Technical SW degree or equivalent with 8+ years of validation expertise

• Life Sciences demonstrated experience

• Compliance & GxP training

Position ID: J0318-0881

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