Multiple vacancies in Parexel: Require Senior Quality Specialist/Quality Specialist II, Research Operations Assistant, Quality Manager, Clinical Data Analyst II

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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:

  • Senior Quality Specialist/Quality Specialist II {below}

Post: Senior Quality Specialist/Quality Specialist II


Job Description:
Perform or assist the performing of quality assessments (e.g. quality gates, gap assessment, study file review), feeding back results to the operational teams, line manager and head of the eClinical Process & Training as appropriate.
* In conjunction with PAREXEL Academy, determine local training requirements (e.g. in quality processes, SOPs, software, etc.), and where needed support training delivery to ensure operational staff have appropriate training per the functional curricula to support their role.
* Working with the Process Optimization and Management (POM) group, ensure timely review and maintenance of Controlled Documents (e.g. SOPs and Work Instructions) in accordance with the defined timelines (e.g. every two years).
* Provides support and advice to operational groups on the application of, and adherence to processes and the use of systems.
* Supports eClinical Process & Training and operations staff at audits, client assessments or regulatory inspections, as needed.
* Research and advise on relevant regulatory and industry trends and initiatives to ensure company stays current on GxP compliance issues.
* Ensure knowledge of PAREXELs and third party vendors product lines.
* Facilitate reporting, handling and follow up of Quality Issues.


Experience:
3+ years of EDC database set up related technical experience (InForm, Rave, DataLabs).
SAS programming skills and understanding of CDISC preferred.

Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 7th Oct, 2012
Req Number:
pare-10016010

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