Career Opportunity in Parexel | Join as Quality Specialist, Clinical Data Analyst I (Coder), Clinical Database Programmer II, Quality Specialist 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: Quality Specialist

Job Description:
Provide support to the TQM team and perform TQM 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 implementation of functional, or cross-functional, systems and tools in line with PAREXEL Operations and PAREXEL Quality Management strategies
- Support development and implementation of project plan, as required, for assigned projects
- Provide support to the CSV lead on assigned projects
- Provide support to trainers in technical aspects
- Provide support during regulatory inspections, audits and/or client audits
- Provide support to the Designated Responsible Individual (DRI) for assigned systems
- Maintain the System Register entries for all systems
- Maintain VSG documentation system
- Create and maintain the web site and associated enhancements for VSG/Software
- Provide support in the creation of test scripts
- Create and enter test data for CSV/Software activities
- Execute process and system testing as part of CSV 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
- Perform all tasks as reasonably requested

- Excellent interpersonal, verbal and written communication skills
- Client focused approach to work
- A flexible attitude with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload
- Willingness to work in a matrix environment and to value the importance of teamwork
- Be able to function as part of a `virtual, global team as required
- Meticulous attention to detail
- Basic computer skills including familiarity with MS Office
- Ability to organize and plan tasks
- Ability to travel as needed for the position and to support other offices
- Effective time management in order to meet team objectives
- Commitment to project and team goals
- Ability to follow instructions
- Must be able to work independently but seek guidance when necessary
- Exhibits a sense of urgency about solving problems and completing work
- Shows commitment to and performs consistently high quality work
- Seeks opportunities to develop experience and knowledge

- Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
Language Skills
- Excellent English written and oral communication skills
Minimum Work Experience
- Relevant experience preferred if no Bachelor's degree

Additional Information:
Location: India - Andhra pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 20th Jan, 2012


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