Engineer (m/w/d) Quality Assurance - Batch Record Review in Mannheim (1604)

Your career in the pharmaceutical industry – ensure highest production standards.

As an Engineer (m/w/d) in quality control, you will take on a central role in GMP-compliant documentation and batch testing for the pharmaceutical industry. You will ensure compliance with regulatory requirements, analyze process data, and support optimization of production processes.

Tasks

• Documentation Review: Control and approval of manufacturing instructions (HABs) and changes according to GMP guidelines.
• Batch Management: Responsible for maintaining the Order Lead Time (OLT) with tracking of required supporting documents.
• Audit Preparation: Support during GMP audits as well as processing regulatory measures.
• Training & Standards: Creation and adaptation of SOPs, as well as conducting internal employee training sessions.
• Data Analysis: Electronic recording and evaluation of production data to identify potential for improvement.
• System Introduction: Participation in the implementation of new Electronic Batch Record (EBR) systems.

Qualification

• Qualification: Completed studies in biotechnology or a comparable field.
• Experience: Professional experience in pharmaceutical production, preferably in parenteral production.
• Professional Knowledge: Good knowledge of GMP guidelines, hygienic standards, and experience in pharmaceutical documentation.
• IT Competence: Secure handling of MES, SAP, as well as MS Office (Excel and Word).
• Soft Skills: Communication strength, organizational skills, sense of responsibility, and process-oriented thinking.
• Languages: Very good German and English language skills in writing and speaking.

Benefits

• Attractive Conditions: Look forward to an unlimited full-time position at BRÜGGEN ENGINEERING, with a salary that reflects your expertise.
• Innovative Projects: Take on a key role in pharmaceutical quality assurance with direct influence on product and process optimization.
• Dynamic Team: Become part of a team that values personal growth and a culture of support and promotion.

We look forward to your comprehensive application documents with
specification of your earliest start date and salary expectations.

Your contact person for your application is:
Mr. Dipl.-W.-Ing. Thorsten Schermann

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