Gcp Consultant

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.

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 Clinical Quality Consulting Pvt Ltd (ADAMAS Consulting PVT) is an independent provider of GXP Quality Assurance services to the pharmaceutical, biotechnology and healthcare industries.

ADAMAS Consulting PVT, incorporated in 2013, is the fully owned subsidiary of ADAMAS Consulting Group Ltd based in the UK.

Responsibilities:

• Delivery of projects in compliance with agreed project proposals
• Prepare, conduct and report GCP investigator sites/system audits for both client and service providers as well as inspection support
• Conduct mock GCP inspections
• Perform the role of Project Lead and Client Liaison
• Project management of audit programs
• Delivery of consultancy services e.g., GCP system reviews, vendors, QMS gap analysis and adhoc consultancy
• Line Management responsibilities

Qualifications Requirements**:

• Master's Degree in Life Science, preferred
• Experience in conducting and leading investigator site audits
• Experience in conducting and leading internal and external GCP audits for a variety of stakeholders (e.g., sponsors, contract research organizations, GCP vendors etc)
• Experience in conducting and leading laboratory audits (GLP, GcLP) considered an advantage, but is not essential
• Experience in coordinating and managing inspection preparation activities for GCP process inspections
• Experience in conducting GCP mock inspections to Competent Authority standards considered a significant advantage
• Expert knowledge of national and international GCP legislation and guidelines
• Proficient in managing projects and ensuring deliverables are provided timeously
• Ability to identify issues and offer solutions in a pragmatic way

Other Requirements:

• Strong communication skills
• Excellent writing skills
• Positivity, flexibility, and adaptability
• Highly professional and selfmotivated
• 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

Additional Information

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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