Quality Assurance Specialist - Shopfloor

Quality Assurance Specialist – Quality On The Shopfloor | On-site 100%

 

Job Description

A global biopharmaceutical manufacturing environment is seeking a Quality Assurance – Quality On The Shopfloor Specialist to ensure GMP compliance and real-time quality oversight directly within production areas.

Reporting to the QA Supervisor, this role is responsible for quality assurance of routine GMP shopfloor activities across Bulk Drug Substance (BDS) and Aseptic Fill & Finish operations for biological products. The position requires strong on-the-ground presence in production zones, working closely with manufacturing teams to ensure product quality, proactively identify compliance risks, and drive continuous improvement.

The Associate acts as the primary Quality reference in production areas, supporting operations through coaching, real-time problem solving, and proactive risk identification while maintaining strong collaboration between Quality and Production teams.

 

Essential Requirements

· Technical and scientific academic background

· 2–3 years of experience in a cGMP pharmaceutical environment within Quality Operations or Manufacturing, ideally in sterile injectable production

· Strong knowledge of pharmaceutical manufacturing processes from cell culture to aseptic filling

· Experience with unit operations, production equipment, gowning procedures, and environmental monitoring

· Experience reviewing production documentation (e.g., batch records) in production areas

· Ability to observe critical production activities and support real-time issue resolution on the shopfloor

· Strong understanding of GMP requirements and internal quality procedures

· Ability to act as a Quality partner to Operations without replacing Production responsibility

· Experience coaching operational teams in event and deviation management

· Ability to identify root causes of deviations and support problem-solving activities

· Experience conducting planned and unplanned shopfloor quality walkthroughs

· Proactive ability to identify potential quality and compliance risks in collaboration with production

· Strong communication and coaching skills with the ability to simplify complex quality requirements

· Excellent listening skills and ability to work collaboratively with multiple stakeholders

· Fluent French (perfect command required)

· Proficient use of Microsoft Office tools

 

Preferred Requirements

· Strong attraction and motivation for working directly in production areas

· Ability to document, share best practices, and objectively report observations and improvement opportunities

· Ability to escalate relevant observations during governance meetings

· Ability to explain and give context to quality decisions to operational teams

· Knowledge transfer and coaching mindset

 

Practicalities

Start Date: ASAP

Location: On-site (100%) – Pharmaceutical production site

Reporting Line: QA Supervisor

Scope: Shopfloor Quality oversight across BDS and Aseptic Fill & Finish operations

Working Hours: 2×8 shifts (Morning 06:00–14:30 / Afternoon 14:00–22:30)

 

Interested? Send your CV to Miguel Gomes at m.gomes@panda-int.com or call +31 (0)20 2044 502 / +41 (0)44 5514 407 to discuss the opportunity.