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Job Details

Quality Specialist I

Company: PAREXEL
Location: Berlin, Land Berlin,Germany
Reference: 47924BR
Closing Date: 17 Jan 19
Type: Not Specified
Salary (£): Competitive
Benefits:

Job Summary:

PAREXEL has an exciting opportunity for a Quality Specialist to join our Logistic Quality team in Berlin-Schonefeld.Quality Specialist I will perform Quality Control tasks in depot and warehouse operations and serve as a quality consultant to designated operational groups, as assigned by Line Management. ...

Requirements:

PAREXEL has an exciting opportunity for a Quality Specialist to join our Logistic Quality team in Berlin-Schonefeld.
Quality Specialist I will perform Quality Control tasks in depot and warehouse operations and serve as a quality consultant to designated operational groups, as assigned by Line Management.

Key Accountabilities:

As Quality Specialist in depot/warehouse operations:

  • Execute QC checks of Medicinal Products and other quality critical Clinical Trial Supplies during receipt, production and distribution
  • Provide support for Change Control management related to premises, equipment and processes in depots/warehouses
  • Support premise and equipment (P&E) maintenance and cleaning
  • Undertake local P&E Quality tasks as defined in PAREXEL procedures to cover local QA tasks
  • Perform review of Production Batch Records
  • Perform and support P&E qualification/validation activities


Other responsibilities:
  • Identify process improvement opportunities
  • Process authoring and review, support for process re-engineering,
  • Providing GxP and process expertise to designated operational group(s),
  • Contribution to the development of training materials as process subject matter expert,
  • Support for identification, management and prevention of quality issues,
  • Participate in SOP and process development, as assigned
  • Work with the relevant training functions including PAREXEL Academy/Learning & Development and Operations. Assist with the development or enhancement of training materials, as assigned
  • Participate in development of quality-related processes and tools
  • Verify compliance with GxP guidelines, local regulations, protocol, PAREXEL procedures and/or sponsor requirements.
  • Provide audit and inspection support, as assigned. This may include:
    • provide assistance/advice for audit/inspection preparation
    • represent Quality Management in audits and inspections, as assigned
    • review assigned audit/inspection responses
  • Provide support for management of quality issues. Facilitate and advise on corrections, corrective and preventive actions related to designated quality issues.
  • Perform Process Lead role for strategic accounts (Partnerships) and/or key accounts or provide process support to strategic accounts (Partnerships) and/or key accounts, as assigned.
  • Attend (or where required, lead) internal quality-focused meetings
  • Maintain a familiarity with PAREXEL systems and related processes, PAREXEL Standard Operating Procedures and relevant regulations and guidelines
  • Share information in an open, balanced and objective manner with other Quality Management and other PAREXEL professionals to maintain positive, results-oriented team environment
  • International travel as needed upon request.
QualificationsSkills:
  • English proficiency (written and oral English)
  • Local language proficiency (written and oral)
  • Excellent interpersonal, verbal and written communication skills
  • Client-focused approach to work
  • Ability to work independently, takes initiative, and has 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 for the position
  • Ability to think and work globally and be culturally aware

Knowledge and Experience:
  • Relevant experience in the Clinical Research field (pharmaceutical industry or CRO), clinical or medical experience or other relevant experience in the areas Logistics Quality Management (LQM) support preferred
  • Project management/technology/business operations experience, as appropriate, preferred
  • Knowledge of GxP regulations preferred
  • Training experience, as appropriate, preferred

Education:
  • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent experience.
Skills:
  • English proficiency (written and oral English)
  • Local language proficiency (written and oral)
  • Excellent interpersonal, verbal and written communication skills
  • Client-focused approach to work
  • Ability to work independently, takes initiative, and has 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 for the position
  • Ability to think and work globally and be culturally aware

Knowledge and Experience:
  • Relevant experience in the Clinical Research field (pharmaceutical industry or CRO), clinical or medical experience or other relevant experience in the areas Logistics Quality Management (LQM) support preferred
  • Project management/technology/business operations experience, as appropriate, preferred
  • Knowledge of GxP regulations preferred
  • Training experience, as appropriate, preferred

Education:
  • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent experience.

Apply for this job: Quality Specialist 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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