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Lead Compliance Associate – PharmaNet Development Group

Monday, March 2, 2009

Category: Jobs. Tags: Control & Testing / ISO, Engineering - Health / Safety, Engineering - Others, Jobs in Singapore, Life Science - Others, Pharmaceutical, PharmaNet Development Group, Quality Assurance.

PharmaNet Development Group, a global, drug development Company, provides a comprehensive range of services to the pharmaceutical, biotechnology, generic drug, and medical device industries. The Company offers clinical-development solutions including early stage and late stage consulting services, Phase I clinical studies and bioanalytical analyses, and Phase II, III and IV clinical development programs. With approximately 2,200 employees and more than 35 facilities through out the world, PharmaNet is a recognized leader in outsourced clinical development.

We are looking for energetic and motivated individuals to join our PharmaNet Singapore office. Visit our website www.pharmanet.com to find out more about us.

Lead Compliance Associate (Asia Pacific)

Job Functions:

Provide project management oversight for assigned projects (timelines, deliverables)
Develop Quality Audit Plans for each assigned project
Write and revise QA SOPs
Present investigator responsibilities and GCP compliance requirements at investigator meetings
Conduct Data Protection compliance audits
Conduct Health and Safety compliance audits
Conduct internal process audits to ensure compliance with applicable SOPs
Ensure critical and major audit findings are entered into the Corrective and Preventive Action system and are tracked to resolution
Provide monthly CAPA metrics to senior QA management
Conduct audits of vendors, sites, databases, CSRs, TLGs and other project related processes as assigned
Provide training to inexperienced auditors and conduct on-the-job training including co-auditing
Act as lead auditor on global projects

Minimum Requirements:

Bachelor’s Degree, preferably in science or RN; in lieu of a degree, nine years of relevant experience may be considered
Five years of relevant health care industry experience (which may include Pharmaceutical Co., CRO or FDA) with at least three years in the GCP compliance area
Ability to work independently
Excellent verbal and written communication skills
Ability to travel up to 40% of their time
Excellent working knowledge of GCP regulations EU Directives and guidelines

Interested candidates to email us your resume or apply through our career page of our Pharmanet website www.pharmanet.com