Senior Associate QA (Level 4)

Location Netherlands
Discipline: Pharmaceutical
Contact name: Ernest Banor

Contact email: e.banor@panda-int.com
Job ref: 17452
Published: 16 days ago

Senior Associate QA (Level 4)

IMPORTANT INFO:

We are looking for an outgoing, multi-tasking mediator with strong communication skills and the ability to work under pressure. GMP experience is a plus.

Please note! This is a 3-shift job. Early shift: 06.30 - 15.00 Late shift: 14.30 - 23.00 Night shift: 22.30 - 07.00 Thoroughly discuss this with your candidates - 100% commitment is needed.

Objectives:

  • Provide QA guidance and support in the production area at ABR.
  • Perform batch record review of batches assembled, packaged, and labelled at ABR.
  • Establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management, and the Qualified Person.
  • Provide daily guidance and support to Production staff in regard to compliance with Standard Operating Procedures and Work Instructions.
  • Act as a first point of contact in case of production queries (quality related) during packaging and labelling operations.
  • Review and approve batch production record data entries before production activities take place.
  • Perform finished product checks during (commercial) production runs.
  • Compile and review batch records for lots assembled, packaged and labelled at ABR in preparation for disposition by QP.
  • Perform GMP compliance checks in production.
  • Review and approve deviation records.
  • Initiate and own QA deviations as needed.
  • Act as author for operational SOP’s and Work Instructions, as needed.
  • Review of operational SOP’s and Work Instructions, as needed.

Requirements:

  • Master’s degree in Pharmaceutical/Life Sciences or related field or the equivalent combination of education and/or experience.
  • Typically, 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.
  • Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.
  • Manufacturing and/or Quality analytical processes and operations
Start date: ASAP
Location: Breda