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GCP Consultant
4 months ago
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 ad-hoc 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
- Acting as subject matter expert to ensure effective inspection preparation management
- 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 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
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
We look forward to welcoming your application.
