Job Description

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About Fresh Gravity:

Founded in 2015 and rapidly expanding, Fresh Gravity (www.freshgravity.com) is a business and technology consulting company at the cutting-edge of digital transformation. We drive digital success for our clients by helping them adopt transformative technologies that make them nimble, adaptive and responsive to their rapidly-changing business needs. Our unparalleled digital transformation expertise combines business strategy prowess with digital technologies know-how. Our expertise includes Data Management, Artificial Intelligence, Data Science & Analytics, and API Management & Integration.

In a short time, we have crafted an exceptional team who have delivered impactful projects for some of the largest corporations in the world. We are on a mission to solve the most complex business problems for our clients using the most exciting new technologies. And we are looking for top talent to join us in our quest.

Fresh Gravity\'s team members are authorities in their field, but know how to have fun, too. We\'re building an inspiring, open organization you\'ll take pride in. We challenge ourselves to grow - every day. We create value for our clients and partners - every day. We promise rich opportunities for you to succeed, to shine, to exceed even your own expectations.

We are thoughtful. We are engaged. We are relentless. We are Fresh Gravity.

Fresh Gravity is an equal opportunity employer.

Requirements:

This position will be responsible for all Quality Assurance GCP activities. The primary responsibilities will be to ensure quality and compliance of clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country specific, and current industry standards and practices) as well as support the non-clinical team on ensuring GLP studies are conducted in a compliant manner.

Responsibilities

• Planning, leading, conducting, documenting and following up on GCP audits according to the requirements specified in the respective SOP\'s and applicable guidance documented.
• Assist with the preparation and facilitation of regulatory agency inspections e.g., MHRA, TGA, FDA, ANVISA inspections
• Working on GCP activities such as in-process audits, system/process audits, vendor audits (high & low risk vendors), investigator site audits and escalating to the management in case of critical audit findings and supporting immediate follow-up measures
• Provide GCP and GLP QA oversight and support to internal staff.
• Assist Clinical Ops in the development of Clinical SOPs and other quality documents.
• Ensure the timely and effective follow up of all identified or assigned quality issues
• Assist in preparing investigational sites for regulatory inspections.
• Conduct QA review of GCP protocols, ICFs, CSRs and other clinical trial specific documents.
• Conduct QA review of GLP reports.
• Schedules and/or delivers yearly GCP training for internal staff.
• Assists with GCP training of study site personnel as needed.

Minimum Qualification -

• Bachelor\'s Degree in a scientific discipline, a combination of relevant education and applicable job experience may be considered.
• Minimum of 8 years in the Pharmaceutical industry with 5 years in GCP QA.
• Solid understanding of GCP, GLP and ICH clinical requirements
• Experience with both domestic and international clinical studies

Benefits:

In addition to a competitive package, we promise rich opportunities for you to succeed, to shine, to exceed even your own expectations. In keeping with Fresh Gravity\'s challenger ethos, we have developed the 5Dimensions (5D) benefits program. This program recognizes the multiple dimensions within each of us and seek to provide opportunities for deep development across these dimensions. Enrich Myself; Enhance My Client; Build my Company, Nurture My Family; and Better Humanity.

Fresh Gravity