Video Information
PAREXEL International Corporation Ltd Openings For Quality Specialist II, TQM Jobs In Hyderabad Apply Online
PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in approximately 70 locations throughout over 50 countries around the world, and has more than 13,000 employees. At PAREXEL, we have a passion for making a profound difference. As an expertise-based business, the caliber of our people and their dedication directly impacts our success, the success of our clients, and the ability to make a difference in the lives of patients worldwide. You'll be surrounded by supportive leadership and a brilliant team who share a common goal - to improve the lives of millions of patients.Designation:Quality Specialist II, TQM
Job Description :
PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. PAREXEL Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in approximately 70 locations throughout over 50 countries around the world, and has more than 13,000 employees.
At PAREXEL, we have a passion for making a profound difference. As an expertise-based business, the caliber of our people and their dedication directly impacts our success, the success of our clients, and the ability to make a difference in the lives of patients worldwide. You'll be surrounded by supportive leadership and a brilliant team who share a common goal - to improve the lives of millions of patients.
Essential Function:
Provide support to the IT team's team and perform QM activities on assigned projects, commensurate with experience and / or project role. General responsibilities include maintaining system register entries, creating test data, performing testing, creating documentation to PAREXEL standards as required. Work to the appropriate corporate standards of quality and efficiency, WSOPs/Guidelines, ICH-GCP and/or other international regulations as applicable.
Key Accountabilities:
- Promote a positive, results orientated work environment, building partnerships and modeling teamwork, communicating 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
- Support the development and implementation of functional, or cross-functional, IT infrastructure , software, systems and tools in line with IT, PAREXEL Operations and PAREXEL Quality Management strategies
- Support development and implementation of project plans, as required, for assigned projects
- Provide support to trainers in technical aspects
- Provide support during regulatory inspections, audits and/or client audits
- Act as Designated Responsible Individual (DRI) for assigned IT infrastructures, software & systems
- Maintain the System Register entries for IT infrastructures, software or systems
- Maintain documentation of IT infrastructures, software or system
- Create and maintain the web site and associated enhancements for TQM
- Create and Maintain qualification and validation plans as well as repots for IT infrastructures, software developments and computerized systems
- Support monitoring programs that aim at continuously evaluating and improving IT service quality
- Perform Release and Infrastructure Assessments evaluation of IT infrastructures, support teams and software releases
- Perform Assessments of 3rd party IT providers or IT outsourcing partners (Specialist II)
- Train IT staff in related SOP especially those design and managed by TQM
- Provide support in the creation of test scripts
- Execute process and system testing as part of Qualification or Validation activities
- Prepare, review and maintain relevant Controlled Documents
- Keep abreast of regulatory requirements and technical innovations
- Participate and contribute in project team and departmental meetings
- Document and implement internal customer requests and/or team decisions
- Perform project tasks in accordance with project timelines and to the required quality standards
- Utilize appropriate TIME codes as they relate to a particular task
- Keep manager(s) informed about work progress and any issues to avoid surprises. Requires significant interaction / supervision by Manager or assigned mentor (Specialist I)
- Perform all tasks as reasonably requested
0 Comment