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
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.
* Develop project plans for assigned projects in line with Operations and eClinical Process & Training strategies.
* Where assigned, work with Operational groups to provide expert review of client-defined processes / quality and/or training materials.
* Investigate internal quality issues, and provide suggestions for process improvements to the appropriate Operations team and Process QM management. Monitor until resolution.
* Monitors and reports on audit responses, providing metrics as appropriate. Supports staff in use of automated quality systems. Confirms closeout of assessment findings, remediation of RRC audit and regulatory inspection findings in accordance with stated response times.
* Reviews the results of operational QC processes. Initiates escalation of significant quality events to the Head of eClinical Process & Training and the responsible line manager.
Candidate Profile:
3 to 7 years of Clinical Data Management, Database set up related technical experience (Rave, Datalabs, Oracle Clinical & OC-RDC).
Clinical Coding Skills and Good understanding of Clinical Database Set Up activities preferred.
Additional Information:
Location: Andhra Pradesh - Hyderabad
Functional Area: QC
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 19th Dec, 2012
Req Number: pare-10022718
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