Senior Associate QA (GMP)

Senior Associate QA (GMP) – Breda

Orion Group Life Sciences are currently recruiting a Senior Associate QA (GMP) on behalf of our Multinational Biopharmaceutical Client based in Breda, on an initial 12-month contract with potential to extend.

Shift Structure
Please note: This is a 3-shift position, following the rotation below:

• Week 1 – Night Shift
• Week 2 – Late Shift
• Week 3 – Early Shift
• Week 4 – Late Shift
• Week 5 – Early Shift

Shift Times:

• Early Shift: 06:30 – 15:00
• Late Shift: 14:30 – 23:00
• Night Shift: 22:30 – 07:00

Important: Please thoroughly discuss the shift structure with candidates. 100% commitment to the shift pattern is required.

Objectives & Responsibilities

• Provide QA guidance and support within the production area at ABR.
• Perform batch record reviews of batches assembled, packaged and labelled at ABR.
• Establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management, and the Qualified Person (QP).
• Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures (SOPs) and Work Instructions.
• Act as the first point of contact for quality-related production queries 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 the QP.
• Perform GMP compliance checks within production.
• Review and approve deviation records.
• Initiate and own QA deviations as required.
• Act as an author for operational SOPs and Work Instructions, as required.
• Review operational SOPs and Work Instructions, as required.
• Assist in the development and delivery of GMP training activities for QA and Production staff.
• Participate in QA production-related projects, as required.
• Assist with various investigations, as required.
• Assist with ABR projects and continuous improvement efforts, as required.
• Prepare weekly and monthly metrics.
• Own and maintain departmental performance boards.

Minimum Requirements

• MSc or BSc degree in Pharmaceutical Sciences, Life Sciences, or a related field, or an equivalent combination of education and relevant experience.
• Typically 3+ years of relevant Quality Assurance or manufacturing experience within the pharmaceutical or medical device industry, including experience with batch record review and investigations.
• Knowledge of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and/or Good Clinical Practice (GCP), with the ability to interpret and apply relevant requirements in mainly routine cases.
• Experience with Manufacturing and/or Quality analytical processes and operations.

 


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