Banner Image

Daily new jobs

  • Location

    Netherlands

  • Job title:

    Quality Assurance Specialist

  • Sector:

  • Salary:

    0.0

  • Contact email:

    Carla Garcia

  • Contact phone:

    Carla Garcia

  • Job ref:

    43565

  • Duration:

    2.0

  • Startdate:

    2020-03-18

The Company 

Our client is one of the largest pharmaceutical organizations world-wide, based in South-Holland. Their portfolio include various therapeutic areas such as oncology, respiratory, cardiovascular or infectious diseases. 

Role Description 

As a Quality Assurance Specialist you will be responsible for various activities such as CAPAs, deviation management, change control, batch release... to ensure that the products meet the quality standards. 

Responsibilities 
  • Identifies, classifies and reports deviations, as appropriate and typically works on more complex minor and/or major deviations.
  • Oversees execution of remediation/CAPA activities required to continue production or move a process to the next mile stone. 
  • Authors and reviews SOPs and policies. Create and establish process and procedures to ensure compliance and adherence to regulations and cGMP operations.
  • Responsible for providing quality oversight to the change management system for change controls. 
  • Review pre-executed batch records and independent technical review of documentation post-execution of cGMP activities. 
  • Participate in quality oversight of manufacturing, real-time observations of activities
  • Work closely with others to recognize opportunities for improvement and drive change through the use of QMS.
  • Participate in internal audits for compliance with SOPs, GMPs, and regulations.
Requirements 
  • Bachelor’s degree in biology, or chemistry, microbiology, or equivalent.
  • A minimum of 2 to 5 years of Quality Assurance experience in the pharmaceutical industry.
  • Demonstrated knowledge of cGMPs in a manufacturing environment.
  • Strong independent judgement and decision-making abilities.
  • Demonstrated problem detection and problem resolution skills.
  • Must possess good verbal and written skills.
Other Information 

For more information please contact Carla Garcia at +31 (0) 20 658 98 01 or c.garcia@sire-search.com. 



 

Contact