Katalyst Healthcares & Life Sciences
IT Quality Lead (CSV)
Katalyst Healthcares & Life Sciences, Boston, MA, United States
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