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 II, TQMO
Job Description:
• Custodian and leader of the PAREXEL Quality System. Acts and is recognized as an ambassador for quality across the business and with customers.
• Supports development, implementation and management of PAREXEL strategic objectives.
• Contact for management and peers across the business to establish and maintain a communication framework that removes constraints and ensures timely and effective action related to matters of quality.
• Performs general and administrative tasks including accurate and timely completion of TIME and travel expense reports.
• Schedules, performs and reports quality evaluations and assessments for client projects, software systems and infrastructure items, to verify compliance with GxP guidelines/regulations, PAREXEL policies and procedures, client requirements and to determine that adequate Quality Control (QC) has been implemented.
• For technology-related Quality Issues (QIs), provide support to internal customers with QI management, with particular emphasis on appropriate description of the issue, accurate classification, oversight of root cause analysis and consultation on appropriateness of corrective and preventive actions.
• Provide advice and consultation to internal customers regarding quality-related aspects of client projects, software systems and infrastructure items.
• Provide, on request, QI and evaluation/assessment metrics to internal and external customers regarding client projects, software systems and infrastructure items.
Candidate Profile
• Entry/mid-level experience in computer technology quality and compliance (including computerized system validation) and the pharmaceutical industry across multiple disciplines within Clinical Drug Development (Phase I/II/III/IV) and/or Manufacturing.
• Basic knowledge of continuous improvement methodologies.
• Exhibits competency across core project management activities.
• Excellent interpersonal, verbal and written communication skills, business understanding, negotiation skills and strong organizational skills.
• Ability to work in a customer-focused, fast-paced and rapidly changing environment with the ability to prioritize workload and manage multiple and varied tasks with enthusiasm and supervision.
• Highly motivated, seeks opportunities for development, client-focused, and has the ability to work with guidance on own initiative.
• Exhibits a sense of urgency when addressing problems and ensures completion of commitment.
• Culturally aware and ability to think and work globally.
• Intermediate desktop software skills (MS Office, Excel, Adobe PDF etc.)
• Entry/mid-level Clinical trials and /or research work experience preferred, with emphasis on GCP and technology compliance.
• Familiar in technology as it relates to clinical trial activities, including System Life Cycle process and applicable GCP regulations pertaining to Computer Systems.
• Entry/mid-level knowledge of project management, Lean Six-Sigma, auditing and/or risk management methodologies.
• Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification, or 2+ years clinical research experience.
Additional Information:
Experience: 2+ years
Location: Bengaluru, Karnataka, India
Functional Area: Quality Specialist
Industry Type: Pharma/ Biotech/Clinical Research
End Date: 5th June, 2017
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