Computer Validation Specialist

3 months ago

London, United Kingdom Adamas Consulting Full time

Company Description

ADAMAS is a well-established, leading provider of mission-critical regulatory compliance and consulting services to the global pharmaceutical industry. It operates across Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Computer Systems Compliance (CSC) (together, GxP).

Founded in 2007, ADAMAS has focused on ensuring that the highest standards of best practice are attained across the pharmaceutical sector. ADAMAS has an established client base with an expansive global reach, including North America, Europe, and Asia Pacific. We work with over 100 currently active clients and have worked with over 700 pharmaceutical companies, including 40 of the 50 largest global pharma and biotech companies.

At ADAMAS, our people are our primary asset. We possess the highest and broadest level of in-house knowledge and can deliver genuine expertise and experience globally via in-house resources. ADAMAS's success is down to the calibre of its people - to reward them we offer a competitive salary with benefits, excellent working conditions and a fulfilling and rewarding career, with plenty of opportunities for further development.

**Job Description**:

- Development, implementation, and maintenance of computerized system’s state of validation and compliance throughout its SDLC.
- Assist, Author/Review in preparation of CSV deliverables such as Validation Plan, Test Plan, Summary Reports.
- Conduct CSV vendor and system process audits.
- Conduct CSV and QMS internal audits.
- Authorship, generation, and execution of validation documents (System Testing, IQ, OQ, PQ, UAT), for GxP regulated computerized systems.
- Review test scripts including IQ, System Testing and UAT scripts.
- Perform Data Integrity, Supplier Qualification and FDA 21 Part 11 assessments.

**Qualifications**:

- Knowledge of validation of GxP computerized systems within FDA regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11, Annex 11, and applicable predicate regulations.
- Up to 10% travel and ability to conduct remote audits.

Additional Information

Why ADAMAS?

As an organization, we prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? Because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:

- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language.

Our core values are key to how we operate, and if you feel they resonate with you then Adamas, an Ergomed Company is a great place to join

Quality

Integrity & Trust

Drive & Passion

Agility & Responsiveness

Belonging

Collaborative Partnerships

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