Post for a Senior Quality Specialist at 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: Senior Quality Specialist
Provide technical expertise, resource and mentoring for the implementation, infrastructure qualification, computer systems validation and ongoing support & maintenance activities related to IT Infrastructure and systems used by PAREXEL staff in daily business and or clinical trial activities. General responsibilities include process improvement projects for IT , providing quality management support pertaining to technical activities, and representing PAREXEL systems in audit/inspections. Work to the appropriate corporate standards of quality and efficiency, WSOPs/Guidelines, ICH-GCP and/or other international regulations as applicable.
- Promote a positive, results orientated work environment, build partnerships and model teamwork, communicate to others in an open, balanced and objective manner
- Deliver best value and high quality service for the benefit of PAREXEL and ensure compliance with PAREXEL Quality standards, Controlled Documents and appropriate regulations
- Lead the qualification of functional, or cross-functional, systems and tools in line with IT, PAREXEL Operations and PAREXEL Quality Management strategies
- Participate in large scale or complex IT infrastructure& systems implementation teams and or consult teams during large scale design projects
- Support development and implementation of project plan, as required, for assigned projects
- Document user requirements and provide input into design specifications to ensure these are met
- Act as Designated Responsible Individual (DRI) for assigned IT infrastructures & systems
- Prepare, review and maintain relevant Controlled Documents e.g. SOPs and Work Instructions
- Create and Maintain qualification and validation plans as well as reports for IT infrastructures and computerized systems
- Support monitoring programs that aim at continuously evaluating and improving IT service quality
- Perform Infrastructure Assessments i.e. evaluation of IT infrastructures & support processes
- Lead and Perform Assessments of 3rd party IT providers or IT outsourcing partners
- Train IT staff in related SOP especially those design and managed by TQM
- Perform hand-off of tasks to relevant groups such as Process and Training, as required
- Keep abreast of regulatory requirements and represent PAREXEL systems at regulatory inspections, audits and/or client audits
- Represent PAREXEL in IT infrastructure& system improvement initiatives
- Initiate escalation of significant quality issues to Management as required
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