Validation Analyst/Senior Validation Analyst, Clinical Research at Lifelancer | chakrie

Requirements

Education

Bachelor's degree in Computer Science, Information Systems, Life Sciences, Engineering, or a related discipline; or equivalent and relevant formal academic / vocational qualification.

Experience

5-8 years of experience in computerized system validation, software quality, or validation within a regulated environment.
Experience supporting GxP-regulated systems in the pharmaceutical, biotechnology, CRO, medical device, or healthcare industries highly preferred.
Experience working within Software Development Life Cycle (SDLC) methodologies.
Experience supporting validation of enterprise applications, SaaS platforms, or commercial off-the-shelf (COTS) software preferred.
Experience with change management and validation documentation in regulated environments.

Additional Requirements

Experience validating cloud-based or SaaS applications.
Experience with Jira, Azure DevOps, HP ALM, or similar tools.
Experience supporting clinical trial systems (CTMS, eTMF, EDC, LIMS, Safety, ERP, or Laboratory systems).
Knowledge of computerized system lifecycle documentation and risk assessments.
Experience participating in regulatory inspections or customer audits.
Strong understanding of Computerized System Validation (CSV) principles.
Knowledge of FDA 21 CFR Part 11, GAMP 5, GxP, ALCOA+ principles, and applicable regulatory guidance.
Familiarity with risk-based validation methodologies.
Working knowledge of SDLC methodologies, including Agile and Waterfall.
Excellent analytical and troubleshooting skills.
Strong documentation, technical writing, and organizational skills.
Excellent verbal and written communication skills.
Ability to manage multiple projects and competing priorities.
Strong stakeholder management and cross-functional collaboration skills.
Experience using Microsoft Office applications including Excel, Word, PowerPoint, and Project.
Ability to quickly learn new technologies and business applications.
Demonstrated commitment to quality, compliance, and continuous improvement.
we are committed to fostering a healthy and harmonious workplace for our employees. We understand the importance of creating an environment that allows individuals to excel. Please see below for the required qualifications for this position
which also includes the possibility of equivalent experience:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require as-needed travel (0-20%).
Location: Remote US position. Relocation assistance is NOT provided.
*Must be legally authorized to work in the United States without sponsorship.
*Must be able to pass a comprehensive background check
which includes a drug screening.

Responsibilities

A clear overview of what is expected, written by the people who posted it, with every detail you need to decide.

Qualifications, experience and the skills that matter most, along with anything that would make you stand out.

Practical next steps, the documents to prepare and the dates to keep in mind before you apply or get in touch.

Contact details, links to the official source and the notes our team adds after checking each listing by hand.

Skills & expertise

Qualifications, experience and the skills that matter most, along with anything that would make you stand out.

Practical next steps, the documents to prepare and the dates to keep in mind before you apply or get in touch.

Contact details, links to the official source and the notes our team adds after checking each listing by hand.

Everything else on this page, kept up to date and available to every member of Chakrie at no cost at all.

Salary & benefits

A clear overview of what is expected, written by the people who posted it, with every detail you need to decide.

Qualifications, experience and the skills that matter most, along with anything that would make you stand out.

Practical next steps, the documents to prepare and the dates to keep in mind before you apply or get in touch.

Contact details, links to the official source and the notes our team adds after checking each listing by hand.

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Validation Analyst/Senior Validation Analyst, Clinical Research

Summary

Requirements

Education

Experience

Additional Requirements

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Experience

Additional Requirements

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