Quality Systems Contractor -CSV

Katalyst Healthcares & Life Sciences

Boston, MA Full Time

POSTED ON 3/3/2025

AVAILABLE BEFORE 6/2/2025

What are the responsibilities and job description for the Quality Systems Contractor -CSV position at Katalyst Healthcares & Life Sciences?

Job Description

Responsibilities :

Leading QA computerization system validation activities with by collaborating with other business units.
Reviewing and strategizing the validation activities against best practices such as CSA, GAMP 5, ASTM, etc.
Review validation deliverables (validation plan, test scripts, URS, etc.).
Solutioning roadblocks without compromising compliance and best practices.

Requirements :

Computer Science / B.S.

3 years' experience in QA / system validation within GXP environments.

Understood GAMP5, 21 Part 11, m Annex 11, GDPR.

Competency in root cause analysis.

Detail oriented and flexible in a dynamic working environment.

Proficiency in MS suite.

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