QA Specialist: MES Excellence in Sterile & Parenteral

Capgemini; Diegem; Vor Ort; EUR 90.000 - 125.000; Vollzeit

Zusammenfassung

Capgemini Engineering in Belgium seeks a QA Specialist to support MES in Sterile Manufacturing and Device Assembly. You will ensure GMP-aligned QA decisions, review master data and process changes, and collaborate with MES, Quality and Business teams to maintain compliance and quality objectives.

Successful candidate has 5–10 years in pharmaceutical manufacturing, aseptic processes, and strong knowledge of cGMP, with Dutch and English fluency and willingness to be mobile to Beerse, Belgium.

Qualifikationen

• University degree, scientific orientation (pharmaceutical, chemical or biological sciences/engineering).
• 5-10 years experience in a Pharmaceutical Industry with knowledge of aseptic manufacturing, annex I and how this relates to set up of batch record and batch release activities.
• Quality-driven mindset and GMP compliance.
• Excellent computer proficiency with experience in MES.
• Ability to work independently while staying connected with key stakeholders; teamwork and open dialogue.
• Ability to handle time pressure and changing priorities; risk-based decisions under time pressure.
• Strong communication and problem-solving with continuous improvement mindset.
• Thorough knowledge of pharmaceutical legislation, cGMP regulations, ICH guidelines; policies and procedures.
• Fluency in Dutch and English; mobility to Beerse, Belgium.

Aufgaben

• Develop and maintain understanding of sterile manufacturing processes to support GMP-aligned QA decisions.
• Provide QA support for MES project in Sterile Manufacturing area.
• Review and approve quality-relevant master data, manufacturing instructions and process changes.
• Participate in projects to optimise workflows for master data and change approvals.
• Ensure compliance with marketing authorization and GMP.

Kenntnisse

Quality mindset

GMP knowledge

Risk management

Analytical thinking

Communication

Teamwork

Decision making

Problem solving

Ausbildung

University degree in pharmaceutical, chemical or biological sciences/engineering

Tools

MES

Jobbeschreibung

Capgemini Engineering in Belgium seeks a QA Specialist to support MES in Sterile Manufacturing and Device Assembly. You will ensure GMP-aligned QA decisions, review master data and process changes, and collaborate with MES, Quality and Business teams to maintain compliance and quality objectives.

Successful candidate has 5–10 years in pharmaceutical manufacturing, aseptic processes, and strong knowledge of cGMP, with Dutch and English fluency and willingness to be mobile to Beerse, Belgium.