Opening for Quality Specialist I\II\Snr in PAREXEL
PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post: Quality Specialist I\II\Snr
Support the development and implementation of an eClinical quality framework including but not limited to process and training material design. Independently review quality and compliance criteria for technology setup for a study program / individual trial. This includes both: an eClinical environment (compilation of systems used & their integrations) & technical study setup of an individual system.
Reports To Manager, Senior Manager, Associate Director, Director or Senior Director
Directly Supervises N/A
Provides Work Direction to N/A
Works Closely with RRC, other PAREXEL Quality groups, CRS and/or Perceptive Operations
External Relationships Sponsor, Sponsor Audit Teams, Regulatory Agency Inspectors, Industry Associations
• Support the development and implementation of an eClinical quality framework
• Independently review quality and compliance criteria adherence for technology setup for a study program / individual trial
• Advise business function on quality and compliance criteria to be met for technology setup activities
• Support and represent quality and compliance (in coordination with business functions) in audits, client assessments or regulatory inspections
• Research and advise on relevant regulatory and industry trends and initiatives to ensure company stays current on GxP compliance issues with respect to technology integrations and study technology setup activities.
• Facilitate reporting, handling and follow up of quality issues.
• Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.
• Works closely with business functions to ensure continuous process improvement.
• Basic understanding of Computer System Validation and Systems Life Cycle.
• Understanding of clinical trial processes (high level) and technologies required in association with clinical trial conduct
• IT literate – Experience with Microsoft based applications and general knowledge of PC functions.
• Culturally aware and ability to think and work globally.
• Ability to travel as needed for the position and to support other offices.
• Excellent interpersonal, verbal and written communication skills
• Client focused approach to work
• A flexible attitude with respect to work assignments and new learning
• Willingness to work in a matrix environment and to value the importance of teamwork.
• The ability to work as a team member or independently, with minimal supervision is necessary.
• The ability to gain trust and confidence with a variety of clients within PAREXEL.
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
Minimum Work Experience
• Experience in one or more areas of computerized system, device and/or process validation, basic understanding of clinical trial process and/or GxP regulatory
• Understanding of clinical technology solutions is a plus.
• Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification/relevant experience in technology, life sciences, pharma and/or clinical research.
• Master’s degree in a science, technology or industry related discipline, preferred
• Fluent in written and oral English
Experience: 4-6 years
Education: Post graduate or PhD degree in Pharmacy/ life sciences
Functional Area: Other
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 15th August, 2015
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