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: Project Quality Lead II
Job Description
• Perform, report, and coordinate the quality evaluations for assigned projects, verifying compliance with GxP guidelines/regulations, PAREXEL procedures and requirements, and sponsor requirements.
• Actively participate in key internal project team meetings and facilitate quality discussions during these meetings.
• Schedule and lead the project related Quality Forums.
• Attend client meetings with project team leadership to collaborate with and participate in discussions related to quality.
• Provide quality advice to the project teams.
• Participate in relevant project team training.
• Provide support with investigation of Quality Issues (QIs) and support of QI management including classification of issues, consultation on appropriateness of corrective and preventive actions.
• Provide audit and inspection support for assigned projects, including, where feasible, advising the project team during preparation and conduct of audits and inspections as per applicable SOPs. Review and provide feedback on project related audit/inspection responses generated by project team members per applicable SOPs. Represent Quality Management in audits and inspections as required.
• Evaluate the quality status of a project by reviewing applicable project quality metrics.
• Identify and evaluate potential risks and quality issues in collaboration with project team leadership and other relevant parties (e.g., Project Management Quality Management, operational and functional staff). Together with these parties, determine appropriate mitigation measures.
Other Accountabilities
• Identify process improvement opportunities and communicate to process owners.
• Participate in SOP and process development as assigned.
• Maintain an understanding of PAREXEL Standard Operating Procedures that are relevant to the assigned project(s) and of relevant regulations and guidelines.
• Perform other quality related tasks or roles (such as Portfolio Quality Lead role) as assigned.
Skills
• Excellent interpersonal, verbal and written communication skills
• Client focused approach
• Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail and strong organizational skills
• Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization
• IT literate: experienced with Microsoft based applications and general knowledge of personal computer functions
• Ability to travel approximately 30%
Education
• Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
Language Skills
• English proficiency (written and oral English)
Qualifications
• Relevant experience (e.g., in the pharmaceutical or CRO industry or in the Technology field).
Additional Information:
Experience: 2-6 Years
Qualification: B.Pharm, B.Sc
Location: Hyderabad, Telangana
Functional Area: Sales
Requisition: pare-10046470
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 30th October, 2015
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