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Job Details

QA Advisor Validation

Company: Hobson Prior
Location: Sweden
Reference: CWi
Closing Date: 20 Jul 18
Type: Contract
Salary (£): On Application
Benefits: Dependent on Experience

Job Summary:

Start date: asap End date: 2019-12-31 Location: Gothenburg

Requirements:

18 month contract! Quality Assurance Advisor with Validation experience
 
The arena

  • Are you interested in a challenging opportunity within the Development Quality function in one of the world’s leading pharmaceutical companies?
  • The Development Quality function is responsible for quality oversight of the pharmaceutical development activities.
  • We are now looking for a Quality Advisor with GMP focus to our Gothenburg team. 
  • Our pharmaceutical development organizations deal with all facets of the process of turning a molecule into a medicine which can be safely and effectively used by patients.
  • The Quality Advisor role has a broad range of responsibilities to ensure all internal and external requirements are fulfilled for projects in the development phase.
  • You will also have the possibility to contribute with expert advice to the pharmaceutical development functions and to the delivery of our pipeline of exciting new medicines.

The role

  • In your role you will have interactions with internal and external stakeholders as well as with vendors and suppliers. 
  • Provide QA advice into validation activities
  • Provide QA advice into internal/external manufacturing activities of Drug Product and patient medication
  • Perform QA release of internally/externally manufactured and packed Drug Product as part of the Supply Chain to clinical trials
  • Support the pharmaceutical development functions with investigations of deviations, complaints, changes and other quality and compliance decisions in the development projects
  • Provide QA support to pharmaceutical development project with interpretation of GMP regulations
  • Provide appropriate QA input to business improvement projects
  • Collaboration with QA colleagues globally

The role may also include

  • Responsible for QA advice and approval of documentation related to manufacturing equipment and facilities to ensure compliance, including validation, calibration, maintenance and change control.
  • Interpret, trend and report compliance data, to measure and improve quality standards within the pharmaceutical development functions.
  • Develop QA Agreements with suppliers or contractors delivering services or products to the pharmaceutical development Supply Chain.

Minimum requirements – Education and Experience 

  • MSc in pharmacy or engineering with at least 3 years’ experience of working within a pharmaceutical GMP environment
  • Broad understanding of validation and GMP
  • Comprehensive understanding of the pharmaceutical/drug development process
  • Good communicator with experience of interacting effectively across interfaces
  • Fluent in written and spoken English

Preferred requirements

  • Experience preferably within the area of validation
  • Good team working and networking skills
  • Capable of making effective decisions
  • Demonstrate a high degree of personal credibility

 

Start date: asap

End date: 2019-12-31

Location: Gothenburg

 

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Contact Information:

Address:  Hobson Prior Europe GmbH
D4 Platz 3
6039 Root Längenbold
Luzern
Switzerland
CH-6039
Switzerland
Tel:  t: +41 (0)41 455 25 60
Fax:  f: +41 (0)41 455 25 61
Website:  Visit Our Web Site

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