GCP Compliance Oversight Manager, FSP
Thermo Fisher ScientificSalary not specified
- Full Time
- Junior (1 to 2 years)
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical, Biotech, Medical Devices, Research & DevelopmentIndustries
Requirements
Candidates must possess a Bachelor's or Master's degree in Life Sciences or Computer Sciences, and require a minimum of 10 years of experience with Computer Systems Validation within the pharmaceutical industry. Strong knowledge of GxP Requirements, GLP and GMP regulations, and 21 CFR part 11 requirements is essential, along with experience working with laboratory or GxP systems such as ELN, LIMS, and QMS.
Responsibilities
The Validation Lead will define validation strategies for computerized systems and analytical instruments utilized in GxP space, creating deliverables including Validation Plans, Test Protocols, and Traceability matrices while executing protocols. They will conduct user review meetings, lead discussions with Quality Assurance and Compliance groups, perform Risk Assessments, develop and maintain policies and procedures, effectively communicate validation activities to project teams and stakeholders, and act as a liaison between Zifo remote teams and customers in the US and Canada. The role also involves participating in internal Computer Systems Validation initiatives.
Skills
Validation Strategy
Validation Plan
Test Protocols
Traceability matrix
Risk Assessments
Policies and Procedures Development
GxP Requirements
GLP
GMP regulations
21 CFR part 11
Laboratory systems validation
ELN
LIMS
QMS
Zifo
Specialist scientific informatics services provider
About Zifo
Zifo provides specialized scientific informatics services to organizations focused on innovation in the fields of Laboratory/R&D, Manufacturing, and Trial operations. Their services include Digital Transformation Coaching, Business Analysis, Program & Project Management, Managed Services, Validation, and Custom Development & Integrations. Zifo leverages expertise in areas such as Chem & Bioinformatics, Data Science, Cloud computing, High-Performance Computing (HPC), Instrument Data, MultiOmics, Data Modeling, Semantics, and Artificial Intelligence & Machine Learning (AI&ML) to deliver tailored solutions. Unlike many competitors, Zifo emphasizes a collaborative approach, ensuring that they understand and address the specific needs of their clients in the scientific community. The company's goal is to support its customers in advancing science and technology, ultimately enhancing global health and wellbeing.
Key Metrics
None, New YorkHeadquarters
2008Year Founded
GROWTH_EQUITY_NON_VCCompany Stage
Data & Analytics, Biotechnology, HealthcareIndustries
1,001-5,000Employees