Quality Assurance Employee (m/f/d)

GULP Information Services GmbH; Mannheim; Presencial; EUR 60.000 - 85.000; Jornada completa

Descripción de la vacante

Gulp Ag is seeking a Specialist Batch Record Review for a renowned pharmaceutical client in Mannheim. You will conduct GMP-compliant batch testing, review manufacturing documentation for completeness and consistency, and ensure data integrity (ALCOA+).

You will perform process and data analyses, identify trends with statistical methods, support deviations in real-time, and assist internal audits and inspections.

Formación

• GMP-regulated pharmaceutical production experience.
• Experience in batch documentation review or aseptic production.
• Knowledge of EU-GMP guidelines and hygiene regulations.

Responsabilidades

• Conduct batch record reviews across the value stream, checking completeness and logical consistency.
• Perform data analysis to identify trends using statistical methods.
• Initiate and address deviations within the review process and support live batch issues during production.
• Prepare batch documentation for audits/inspections and support internal audits.
• Mentor colleagues as an expert on batch record review.

Conocimientos

GMP expertise

Batch record review

Data integrity ALCOA+

Statistical analysis

Documentation & audits

Educación

Degree in Pharmacy/Biology/Engineering

Herramientas

MES

SAP

MS Office

Descripción del empleo

Do you have a keen eye for detail and want to actively contribute to the safety of high-quality pharmaceuticals? For our renowned pharmaceutical client in Mannheim, we are immediately seeking a dedicated individual to fill the role of Specialist Batch Record Review. Become part of a cross-functional team and help shape innovative quality processes in a future-proof work environment!

GMP-compliant batch testing: You will conduct batch record reviews across the value stream, check manufacturing documentation for completeness and logical consistency, and ensure compliance with data integrity (ALCOA+). Process & data analysis: Based on your in-depth understanding of processes, you will identify and evaluate trends and critical process data using statistical methods and communicate these to production. Deviation management: You will initiate and address deviations within the review process and support operational units with live batch issues during ongoing production. Audit and inspection support: You professionally prepare relevant batch documentation and review processes and confidently present them during internal audits and official inspections. Knowledge multiplier within the team: You assume an expert role for complex issues in the area of batch record review and pass on your expertise to colleagues in a targeted manner.

• Completed studies (e.g. pharmacy, biology, engineering) or completed scientific-technical training with further education as a master craftsman or technician (m/f/d).
• Solid professional experience in GMP-regulated pharmaceutical production (ideally parenteral/sterile or biological drugs) as well as experience in batch documentation review or aseptic production.
• Very good knowledge of the common GMP guidelines (EU-GMP, 21 CFR Part 210/211), document management and relevant hygiene regulations.
• Proficient use of relevant IT systems (MES, SAP, MS Office) combined with strong analytical skills and basic statistical understanding.
• Excellent German skills, both written and spoken, as well as good English skills for confident communication in international project and audit environments.