Validation Lead
Yochana
Validation Lead
Raritan, NJ OR New Brunswick, NJ (Onsite – Hybrid Model ( 3 days a week) )
Long Term Contract
Job Responsibility:
- Must be able to work out of Raritan or New Brunswick Office at least 3 days a week.
- Must be able to independently lead business separation activities for large global & regional GxP computerized systems with minimal supervision.
- Recent experience with acquisitions/separations/divestiture from J&J is a huge plus. Strong CSV expertise, especially within acquisition/divestiture/separation.
- Ability to manage end-to-end from inventory, assessments, remediations to final dispositions; infrastructure qualifications & business systems validations.
- 7-10 years of relevant experience; has experience of leading/advising junior and senior resources.
- Specifically in the pharmaceutical, biotechnology, or medical device industry. Experience in FDA and/or global regulated environment with good understanding of GxP standards and risk-based validation; define and implement risk-based validation activities.
- Experience in writing and executing documentation for all aspects of the validation deliverables (e.g., requirements, compliance/validation plans, test protocols, test summary reports and compliance/validation reports, SOPs/WIs).
- 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.
- Strong verbal and written communication skills.
- Ability to work as a team player, lead a team or accomplish tasks without supervision.
- Ability to work with remote teams and support several changes/projects simultaneously.
Vacancy posted 4 days ago
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