Quality Specialist (RE-34264643)

QA Specialist
Breda - On site

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 labeled 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 regards 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 labeling 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 labeled 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.
• Assist in development and delivery of GMP training activities for QA and production staff.
• Participate in QA production related projects, as needed.
• Assist in various investigations, as needed.
• Assist in ABR projects and improvement efforts, as needed.
• Responsible for preparation of weekly/monthly metrics.
• Own and maintain departmental performance boards.

Minimum Requirements:

• MBO or BSc 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.
• Experience with Manufacturing and/or Quality analytical processes and operations.
• Fluent in English language