Validation Consultant

Clarkston Consulting is seeking motivated, self-driven leaders who are energized by team results and interested in joining a firm that values its culture and people as its biggest strengths. Come join us as a Computer Systems Validation Consultant, and in this role, you will deliver creative business solutions to our market-leading clients in the life sciences, consumer products, and retail industries.

Together, we can find the answers to our clients' most challenging business problems through a combination of our industry expertise, business process knowledge, and consulting excellence.

What You’ll Do

As a Computer Systems Validation (CSV) Consultant at Clarkston you will:

• Apply your professional knowledge of 21CFR Part 11 systems validation and regulatory compliance with a range of computerized systems in pharmaceutical, biotech, medical device, and other GxP and GAMP regulated environments
• Perform as a project execution...

Zifo is hiring! We are looking to add a Validation Consultant to our Quality & Compliance team. This person will be responsible for validation strategy and planning, executing and qualification of computer systems and/or analytical instruments in accordance with applicable policies procedures and regulatory requirements. 

**This role requires 2-3 days per week on-site in Emeryville, CA**

Responsibilities :

·  Define validation Strategy for computerized systems and/or analytical instruments utilized in GxP Space 

·  Create Validation deliverables such as Validation Plan, Test Protocols, Traceability matrix and execution of protocols 

Conduct user review meetings. Lead discussions with Quality Assurance and Compliance groups 

·  Conduct Risk Assessments. Develop and maintain policies and procedures 

·  Effectively communicate the...

Clarkston Consulting is seeking motivated, self-driven leaders who are energized by team results and interested in joining a firm that values its culture and people as its biggest strengths. Come join us as a Computer Systems Validation Consultant, and in this role, you will deliver creative business solutions to our market-leading clients in the life sciences, consumer products, and retail industries.

Together, we can find the answers to our clients' most challenging business problems through a combination of our industry expertise, business process knowledge, and consulting excellence.

What You’ll Do

As a Computer Systems Validation (CSV) Consultant at Clarkston you will:

• Apply your professional knowledge of 21CFR Part 11 systems validation and regulatory compliance with a range of computerized systems in pharmaceutical, biotech, medical device, and other GxP and GAMP regulated environments
• Perform as a project execution...

Clarkston Consulting is seeking motivated, self-driven leaders who are energized by team results and interested in joining a firm that values its culture and people as its biggest strengths. Come join us as a Computer Systems Validation Consultant, and in this role, you will deliver creative business solutions to our market-leading clients in the life sciences, consumer products, and retail industries.

Together, we can find the answers to our clients' most challenging business problems through a combination of our industry expertise, business process knowledge, and consulting excellence.

What You’ll Do

As a Computer Systems Validation (CSV) Consultant at Clarkston you will:

• Apply your professional knowledge of 21CFR Part 11 systems validation and regulatory compliance with a range of computerized systems in pharmaceutical, biotech, medical device, and other GxP and GAMP regulated environments
• Perform as a project execution...

Clarkston Consulting is seeking motivated, self-driven leaders who are energized by team results and interested in joining a firm that values its culture and people as its biggest strengths. Come join us as a Computer Systems Validation Consultant, and in this role, you will deliver creative business solutions to our market-leading clients in the life sciences, consumer products, and retail industries.

Together, we can find the answers to our clients' most challenging business problems through a combination of our industry expertise, business process knowledge, and consulting excellence.

What You’ll Do

As a Computer Systems Validation (CSV) Consultant at Clarkston you will:

• Apply your professional knowledge of 21CFR Part 11 systems validation and regulatory compliance with a range of computerized systems in pharmaceutical, biotech, medical device, and other GxP and GAMP regulated environments
• Perform as a project execution...

Zifo is hiring.. Seeking a highly experienced senior IT professional who can seamlessly hit the ground running in supporting GxP Systems and collaborate cross-functionally with teams such as Quality, Clinical Operations, Pharmacovigilance, and more.

This role entails serving as a GxP IS representative and SME for system implementation and ongoing operations, encompassing access management, access reviews, system administration, risk management, and incident investigations.

You will work alongside the existing Regulated (GxP) Systems staff and Quality as your cross functional partner while providing support and expertise in GxP operations and projects within the realm of information systems.

Requirements

• GxP Computer System administration, support escalation point, and maintenance.
• GxP Computerized System Incident Management and technical investigation.
• Creating SOPs, Guidance Documents, and...