Senior Associate QA (GMP) // Fulltime

€40000 - €70000 per annum
Join the company in Breda as a Senior Associate QA! Be part of groundbreaking DNA technology developments. Apply now for a key role in ensuring the quality of production processes. With a 40 – 70k salary and good benefits. Start your journey with tomorrow!

Company:

This company a pioneering biotechnology company specializing in human therapeutics, is at the forefront of developing groundbreaking medicines based on DNA technology. For over 40 years, they dedicated themselves to scientific discoveries and innovations, introducing numerous biotechnological drugs that have significantly improved the lives of hundreds of thousands facing severe illnesses.

Job Description:

As a Senior Associate QA, you will play a crucial role in ensuring the quality of production processes at ABR. Your responsibilities include:

• Providing QA guidance and support in the production area.
• Performing batch record reviews for assembled, packaged, and labeled batches.
• Establishing effective working relationships with various departments.
• Offering daily guidance to Production staff on compliance with procedures.
• Acting as the first point of contact for production queries during packaging and labeling.
• Reviewing and approving batch production record data entries.
• Performing finished product checks during commercial production runs.
• Compiling and reviewing batch records for disposition by QP.
• Conducting GMP compliance checks in production.
• Reviewing and approving deviation records.
• Initiating and owning QA deviations as needed.
• Acting as an author for operational SOPs and Work Instructions.
• Assisting in the development and delivery of GMP training activities.
• Participating in QA production-related projects.
• Assisting in various investigations and ABR projects.
• Preparing weekly/monthly metrics and maintaining performance boards.

Requirements:

• MBO or BSc degree.
• Fluent in English language;
• Good communication skills;
• Good stakeholder management;
• Good decisionmaker, not afraid to make mistakes;
• Pre, 3 years of related Quality Assurance or manufacturing experience;
• Pre, Knowledge of GMP, GDP, and/or GCP with the ability to interpret and apply in routine cases;
• Pre, Experience with Manufacturing and/or Quality analytical processes and operations.

 

Offer:

40- 70k annual (all in)

Location:

Breda

Position Type:

Full-time, 3 shifts

• Early shift: 06.30 – 15.00
• Late shift: 14.30 – 23.00
• Night shift: 22.30 – 07.00

Contract Duration:

1-year contract (opportunity on a permanent contract after that year)
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