Senior Quality Specialist
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Responsible for providing support to Operations staff in the implementation of and adherence to processes, controlled documents, tools and templates to enhance quality of deliverables.

Activities may include: Identification of process gaps and/or improvement opportunities; process authoring and review; support for process re-engineering; developing related training materials and/or delivering training. Providing GxP and process expertise to designated operational group(s); support for identification, management and prevention of project quality issues; providing audit and inspection support and overseeing the collection and reporting of project quality metrics.

Key Accountabilities:

Quality:
• Work with Quality Management and Operations staff to develop and/or update quality/process documents, tools, and templates. Consider process for effectiveness measurement.
• Coordinate the review of PAREXEL Controlled Documents; summarize and collate responses from the TRG.
• Assist in the maintenance of the relevant website, PAREXEL Connect page and PMED filing areas, as needed.
• Prepare quality metrics reports for management review; distribute and file as directed.
• Support Operations staff in use of automated quality systems.
• Support Quality Management and Operations staff in coordination, preparation for and follow up of internal and external audits and inspections, as requested.

Processes and Systems
• Provide support to operational staff on the application of, and adherence to processes and day to day use of PAREXEL processes and systems used to manage a project, proposal or contract.
• Use process mapping and analysis techniques to identify areas for efficiency gains and process improvements within Operations and Quality groups, with subsequent development and implementation of action plans.

Training
• Develop training or assist with development, enhancement and delivery of training as assigned.
• Adhere to all controlled procedures regarding training.
• Provide advice and mentorship for operational staff and project teams to assist them in the resolution of problems encountered in the conduct of their work or in the application of SOPs/guidelines.

Qualifications:
Skills:

• Excellent interpersonal, verbal and written communication skills.
• Customer focused approach to work.
• A flexible attitude with respect to work assignments and new learning.
• Ability to manage and prioritize multiple and varied tasks efficiently and accurately.
• Willingness to work in a matrix environment and to value the importance of teamwork.
• Some leadership expertise.
• Strong analytical skills.
• Attention to detail and strong organizational skills.
• Ability to work independently and take ownership of, and responsibility for work assigned.
• IT literate – Experience with Microsoft based applications and a general knowledge of PC functions.
• Culturally aware and ability to think and work globally.
• Ability to travel as needed for the position.

Education:
• Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience

Minimum Work Experience:
• Relevant experience in the Clinical Research field (pharmaceutical industry or CRO) or other relevant experience.
• Knowledge of GCP compliance preferred.
• Experience of working in a global environment.
• Relevant experience in Clinical and/or Project Management.
• Relevant experience in the use and/or support of technologies (e.g. Impact, electronic filing systems) preferred.
 
Additional Information
Location | | | Durham Start Date 2013-07-18
Job Type Full Time
Salary Not Provided
Career Level Not Provided Relevant Work Experience Not Provided
Education Level Not Provided Job posted on 18-Jul-2013


Contact Information
Company Name PAREXEL Telephone No Not Provided
Contact Name Site Link Not Provided
 

       

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