Job as Project Quality Lead in 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: Project Quality Lead II

Job Description:
Essential Function
Provide quality oversight to project team management throughout the project. Specifically responsible for standard and risk-based quality interventions including: review of key project documentation, consultation, CAPA support, audit and inspection support, and collection and reporting of project quality metrics.
* Implement the standard quality interventions for assigned projects, verifying compliance with GxP guidelines/regulations, PAREXEL procedures and requirements, and sponsor requirements.
* Review key project documentation and provide feedback to the project team.
* Actively participate in key internal project team meetings and facilitate quality discussions during these meetings, as appropriate.
* Lead quality-focused meetings and/or discussions, as appropriate.
* Provide quality consultation support to project teams.
* Provide CAPA support to project teams including classification of issues, consultation on appropriateness of corrective and preventive actions and tracking of CAPAs through resolution.
* Provide audit and inspection support for assigned projects, including, where feasible, advising the project team during preparation and conduct of audits and inspections. Review and provide feedback on project related audit/inspection responses generated by project team members prior to finalization. Represent Operations Quality Management in audits and inspections as required.
* Oversee the collection and reporting of project quality metrics.
* Identify and evaluate potential risks, in collaboration with project team management and other relevant parties (e.g., Project Management Quality Management, operational and functional staff). Together with these parties, determine appropriate mitigation measures.
* Implement additional quality interventions in areas of risk.
* Identify process improvement opportunities and champion their implementation as assigned.
* 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 as assigned.

Experience:
Skills
* Excellent interpersonal, verbal and written communication skills
* Client focused approach to work
* 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 as needed

Candidate Profile:
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)

Minimum Work Experience
* Relevant experience (e.g., in the pharmaceutical or CRO industry or in the Technology field).

Additional Information:
Location: Andhra Pradesh - Hyderabad
Functional Area: QC
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 19^th Dec, 2012
Req Number: pare-10023488