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Computer Systems Validator
2 months ago
Zifo is seeking a skilled Validation Consultant to join our Quality & Compliance team. This individual will be responsible for developing and implementing validation strategies, executing and qualifying computer systems and/or analytical instruments in accordance with applicable policies, procedures, and regulatory requirements.
Key Responsibilities:
- Develop and implement validation strategies for computerized systems and/or analytical instruments utilized in GxP environments
- Create validation deliverables, including validation plans, test protocols, traceability matrices, and execution of protocols
- Conduct user review meetings and lead discussions with Quality Assurance and Compliance groups
- Conduct risk assessments and develop and maintain policies and procedures
- Effectively communicate validation activities and deliverables to project teams, customer stakeholders, and global teams within Zifo
- Act as a liaison between Zifo remote teams and customers in the US and Canada
- Participate in internal initiatives around Computer Systems Validation
Requirements:
- Bachelor's or Master's degree in Life Sciences or Computer Sciences
- 5-7+ years' experience with Computer Systems Validation within the pharmaceutical industry
- Strong knowledge of GxP requirements, GLP and GMP regulations, and 21 CFR part 11 requirements
- Experience with laboratory or GxP systems validation, such as ELN, LIMS, QMS, etc.
About Zifo:
Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals, and other research-based organizations. Our team's knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 7 of the Top 10 Biopharma companies.
We look for Science – Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology, etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a 'no doors' policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda – technical competency and cultural adaptability.
We offer a competitive compensation package, including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts.
