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, LLC. 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:

• Manage a team of Computer System Compliance (CSC) ADAMAS Consultants on a daily basis to ensure the delivery of high quality services to ADAMAS clients
• 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
• Perform Data Integrity, Supplier Qualification and FDA 21 Part 11 assessments.
• Assist in support computerized systems change management control and periodic review processes
• Exploring new opportunities to add value to organization and departmental processes
• Helping others to accomplish results
• Performing other duties as assigned

Requirements:

• 5-10 years CSV experience
• 3-5 years management experience
• 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
• 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
• Experience with working with a remote Team
• QC of project and audit client deliverables to ensure high standards of work is being maintained

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 team
• Up to 40% travel and ability to conduct remote audits

Benefits of Working at ADAMAS Consulting, LLC:

· Competitive Salary

· 20 Paid Vacation Days

· Working from Home

· Flexible Working Hours

· Pension Contribution

· Additional Benefits

Job Type: Full-time

Pay: $105,000.00 - $140,000.00 per year

Schedule:

• 8 hour shift

Experience:

• CSV: 5 years (Preferred)
• Management: 5 years (Preferred)

Work Location: Remote

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