EMEA Computer System Compliance (CSC) Specialist
This is an immediate, full-time employment opportunity for an ambitious individual who is looking to serve as an industry expert remotely.
ADAMAS’s success is down to the caliber 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.
ADAMAS Consulting, Ltd. is an independent provider of GXP Quality Assurance services to the pharmaceutical, biotechnology and healthcare industries. ADAMAS Consulting, Ltd. established in 1997 is based in the UK and providing services in Europe, the Middle East and Africa.
Responsibilities:
- Assist in 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
- Assist in supporting CSV vendor and system process audits
- Assist in supporting CSV and QMS internal audits
- Assist in 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
- Maintaining current knowledge of regulations, standards, guidance documents, industry initiatives and trend that impact CSV
- Assist in support computerized systems change management control and periodic review processes
- Helping others to accomplish results
- Performing other duties as assigned
Requirements:
- Attention to detail
- Accountability in the workplace
- Preferred to have 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
- Preferred to have Typing speed of 80+ wpm
- Effective written and oral communication skills
- Excellent time management, interpersonal and problem-solving skills
- Must demonstrate the ability to excel in a collaborative team-working environment
- Ability to identify issues and offer solutions in a pragmatic way
Other Skills and Requirements:
Our people and the way we work set us apart. We work closely with our clients, providing industry-leading innovation and knowledge to deliver solutions that add genuine value to their business.
We place great worth on development and collaboration so we can best succeed together. When needed we also place great importance on intellectual curiosity and the ability to work autonomously.
Other Requirements:
- Strong communication skills
- Excellent writing skills
- Positivity, flexibility, and adaptability
- Highly professional and self-motivated
- Ability to work independently in a home office setting
- Confidence to work alone or in a team
- Up to 40% travel and ability to conduct remote audits
What ADAMAS Can Offer You:
- Competitive Salary
- 25 Paid Vacation Days
- Working from Home
- Flexible Working Hours
- Pension Contribution
- Additional Benefits
If you like the prospect of a home-based role, flexible working conditions, excellent benefits and of course the opportunity to further your career within an exciting organization, then please submit your CV to Angela Tompkins at angela.tompkins@adamasconsulting.com.
No unsolicited calls from recruitment agencies please.
