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Katalyst Healthcares & Life Sciences

IT Quality Lead (CSV)

Katalyst Healthcares & Life Sciences, Boston, Massachusetts, us, 02298


Qualifications:

Providing the validation strategy for different computer systems in life sciences industry

Possess expertise in managing acquisitions and divestitures from a Computer System Validation (CSV) perspective.

Comprehensive understanding of the Computer System Validation process, particularly in relation to GxP applications and systems.

Capability to remediate CSV Validation documentation.

Strong understanding of CFR 21 Part 11 and the SDLC lifecycle related to validation requirements.

Ability to work within a team and independently.

Strong English communication and written skills required.

Preferred Qualifications:

Previous experience working for an Innovative Medicine company is preferred.

Additional Experience Required:

Project Leader/Senior 3-7 years of relevant experience

Work independently and guide/mentor Junior resources

Experience in the Pharmaceutical, biotechnology, or medical device industry

2+ years' experience with System Development Lifecycle

3+ years' experience in Computer System Validation (Based on the role selected)

Experience in FDA and/or global regulated environment with good understanding of GxP standards and Risk based validation

Knowledge of FDA guidance and industry standards (i.e., GAMP)

Experience in writing and executing documentation for all aspects of the validation deliverables (requirements, compliance/validation plans, test protocols, test summary reports and compliance/validation reports)

Experience in reviewing system test and user acceptance test scripts, traceability matrix and design specs

Experience in QA Methodologies, designing, reviewing and approving test plans, systems and UAT test scripts and test procedures

Ability to work with remote teams and support several changes/projects simultaneously

Ability to provide validation guidance, timely reviews, and escalations to TQ management

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