Freelance QA MES Specialist – Pharmaceutical Manufacturing
Company: Hays Agency
- Location: Antwerp, Belgium
- Seniority: Entry level
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Are you an experienced Quality Assurance professional with a strong background in pharmaceutical manufacturing and MES?
For a long-term freelance assignment, we are looking for an experienced QA MES Specialist to support a major MES implementation project within a pharmaceutical manufacturing environment.
Depending on your expertise, you will support activities within either pharmaceutical packaging/device assembly or sterile/aseptic manufacturing.
Your new role
As a QA MES Specialist, you will act as a key Quality partner within the MES implementation project. Your focus will be on ensuring that manufacturing processes, master data and documentation within the MES environment comply with applicable GMP and Quality requirements.
Your responsibilities will include:
- Providing Quality support throughout the MES implementation
- Reviewing and approving quality-relevant master data, manufacturing instructions and process changes
- Ensuring compliance with GMP and applicable Quality requirements
- Reviewing and approving relevant GMP documentation
- Supporting the optimisation of review and approval workflows
- Working closely with MES, Production and Quality stakeholders
- Acting as a Quality Point of Contact within the project
- Providing Quality oversight for projects and operational activities
- Making well-informed, risk-based Quality decisions in a dynamic production environment
Your profile
You have a strong QA background within the pharmaceutical industry and experience working in a GMP-regulated manufacturing environment.
More specifically, you have:
- A university degree in pharmaceutical, chemical or biological sciences, engineering, or a related scientific field
- 5–10 years of experience within the pharmaceutical industry
- Strong knowledge of GMP requirements
- Previous experience working with a Manufacturing Execution System (MES)
- Knowledge of batch records and batch release activities
- Expertise in at least one of the following areas:
- Pharmaceutical packaging / device assembly, or
- Sterile / aseptic manufacturing, including knowledge of EU GMP Annex 1
- A quality-driven, analytical and accurate approach
- The ability to work independently while collaborating effectively with multiple stakeholders
- Strong communication and problem-solving skills
- The ability to manage changing priorities and make risk-based decisions
- Fluency in Dutch and English, both written and spoken
What you'll get in return
This is a long-term freelance assignment offering the opportunity to contribute to an important MES implementation and digital transformation project within pharmaceutical manufacturing.
You will work at the intersection of Quality, Manufacturing and digitalisation, collaborating with multidisciplinary teams in a highly regulated environment.
Interested in a long-term freelance project where you can combine your QA, GMP and MES expertise? Apply now or contact us for more information.
