inVentiv Health Clinical, a leader in drug development services, has a global infrastructure, therapeutic expertise, and commitment to quality that is unmatched in the industry. For pharmaceutical, biotechnology, generic drug, and medical device companies of all sizes around the world, inVentiv Health Clinical can help you transform promising ideas into commercial reality.
Post: Strategic Resourcing, Quality Lead / Coordinator
Job Description
This role is involved in maintaining the QA compliance activities for FSP business.
Growth Opportunity: Will get exposed to QA activities in all BUs of FSP like data management, Clin Ops, SAS, Biostats etc
Responsibilities
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Drive FSP adherence to Quality initiative activities, as applicable
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Facilitate the development and oversight of Quality plans, as appropriate
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Review and oversee quality activities performedby functional teams, ensuring appropriate rsolutions to issues identified
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Ensure that CAPA's for functional teams are completed and closed
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Work in conjunction with pharmenet/i3 Quality assurance (QA) and functional teams to provide support for upcoming internal/sponsor audits or regulatory agency inspections.
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Participate in quality related discussions with key clients, as required
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Share cross FSP Quality trends with functional teams
Candidate Profile
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For QA coordinator Candidates should have 2-3 years of experience in corporate QA preferably with FSP/ CRO experience and For QA lead candidate should have 5-6 years of experience in corporate QA.
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Should have working experience in ICH and GCP environments
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Should possess good communication skills
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Preferred have prior Audit experience
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Should be a good team player
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Potential candidate should have out of box thinking and wide perspective of company and role
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Should be well versed with QA metrics
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Should be GCP trained professional
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Good to have global exposure
Additional Information:
Experience: 2-3 Years
Job ID: 6616
Location: Pune
Industry Type: Clinical Research
Functional Area: CR
Last Date: 10th March, 2014
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