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Job Details

Project Quality Risk Lead I

Company: PAREXEL
Location: Berlin, Land Berlin,Germany
Reference: 49396BR
Closing Date: 18 Feb 19
Type: Not Specified
Salary (£): Competitive
Benefits:

Job Summary:

PAREXEL has an exciting opportunity for a Clinical Research Professional, to join our Early Phase Development Quality team as a Project Quality and Risk Lead I.This role is located from PAREXEL Early Phase Development Unit at the Berlin Red Cross Hospital.We are currently offering two roles (permanent and fixted -term contracts).The Project Quality and Risk Lead I will support the Early Phase Development Unit, providing quality oversight throughout the project. ...

Requirements:

PAREXEL has an exciting opportunity for a Clinical Research Professional, to join our Early Phase Development Quality team as a Project Quality and Risk Lead I.

This role is located from PAREXEL Early Phase Development Unit at the Berlin Red Cross Hospital.

We are currently offering two roles (permanent and fixted -term contracts).

The Project Quality and Risk Lead I will support the Early Phase Development Unit, providing quality oversight throughout the project. Specifically, responsible for the conduct of quality evaluations, quality consultation, CAPA support, audit and inspection support, and collection and reporting of project quality metrics.

Key Accountabilities:
•Perform and report quality evaluations for assigned projects
•Verify compliance with GxP guidelines/regulations, PAREXEL procedures and requirements, and sponsor requirements
•Review key project documentation and provide feedback to the project team
•Participate in key internal project team meetings
•Participate in quality-focused meetings and/or discussions
•Attend client meetings with project team leadership to collaborate with and participate in discussions related to quality as assigned
•Provide quality consultation support to project teams
•Provide CAPA support to project teams, as assigned
•Provide audit and inspection support, as assigned
•Identify and evaluate potential risks and quality issues in collaboration with project team leadership and other relevant parties to identify potential mitigation measures
•Collect project quality metrics, as assigned
•Identify process improvement opportunities
•Report process gaps and participate in implementation of process improvement initiatives
•Participate in SOP and process development as assigned
•Participate in working groups as assigned to develop SOP and/or quality related processes
•Maintain an understanding of PAREXEL standard operating procedures that are relevant to the assigned project(s) and of relevant regulations and guidelines
•Maintain compliance with training curriculum
•Consult process SMEs as necessary for guidance
•Share lessons learned across PQL group and/or projects
•Perform other quality related task as assigned.
QualificationsSkills:
• Good 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 good organizational skills
• Detail orientated
• Ability to work effectively in a matrix environment and to demonstrate and foster team work
• IT literate: experienced with Microsoft based applications and general knowledge of personal computer functions
• Occasional travel, as required

Knowledge and Experience:
• Relevant experience (e.g., in the pharmaceutical or CRO industry or in the Technology field).
• English proficiency (written and oral English)
Skills:
• Good 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 good organizational skills
• Detail orientated
• Ability to work effectively in a matrix environment and to demonstrate and foster team work
• IT literate: experienced with Microsoft based applications and general knowledge of personal computer functions
• Occasional travel, as required

Knowledge and Experience:
• Relevant experience (e.g., in the pharmaceutical or CRO industry or in the Technology field).
• English proficiency (written and oral English)

Apply for this job: Project Quality Risk Lead I

Contact Information:

Address:  PAREXEL International
The Quays
101-105 Oxford Road
Uxbridge
Middlesex
UB8 1LZ
England
Tel:  +44 1895 238000
Fax:  +44 1895 238494
Website:  Visit Our Web Site
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