Consultant (m / w / d) Life Science Compliance

ARCONDIS; Frankfurt; Vor Ort; EUR 45.000 - 70.000; Vollzeit

Zusammenfassung

An established industry player is seeking a dedicated professional with a BS degree in pharmaceutical sciences, biotechnology, engineering, or chemistry. This role involves critical responsibilities such as preparing qualification plans, creating SOPs, and ensuring compliance with GMP standards. The ideal candidate will possess practical experience in laboratory settings, strong communication skills in both German and English, and a meticulous approach to quality management. Join a dynamic team where your expertise will contribute significantly to the quality assurance of pharmaceutical products, and enjoy opportunities for professional growth and development in a collaborative environment.

Qualifikationen

• Practical experience in a pharmaceutical laboratory or production environment.
• Very good GMP knowledge and in-depth knowledge of regulatory requirements.

Aufgaben

• Preparation of qualification and validation plans for processes.
• Creation of Standard Operating Procedures (SOPs).
• Support of pharmaceutical release laboratories in GMP activities.

Kenntnisse

GMP knowledge

Quality Management

Analytical methods validation

Communication skills

Attention to detail

Teamwork

Ausbildung

BS degree in pharmaceutical sciences

BS degree in biotechnology

BS degree in engineering

BS degree in chemistry

Tools

LIMS

MES

Jobbeschreibung

• Equipment qualifications, commissioning, and method validations
• Preparation of qualification and validation plans for laboratory and production-related processes
• Preparation and review of specifications and risk analyses
• Planning and execution of IQ-OQ-PQ
• Processing of changes and deviations
• Creation of Standard Operating Procedures (SOPs)
• Maintenance and archiving of documents
• Provide training and ensure training standards
• Support of pharmaceutical release laboratories in GMP activities
• Active support in the business development

Your profile

• BS degree in either pharmaceutical sciences, biotechnology, engineering, or chemistry
• Practical experience in a pharmaceutical laboratory or production environment
• Practical experience in quality Management
• Very good GMP knowledge and in-depth knowledge of other regulatory requirements
• Professional experience in the qualification of laboratory equipment & facilities
• Experience in method validation of analytical methods
• Experience in LIMS or MES environment is an advantage
• Careful, self-contained, and responsible way of working
• Excellent verbal & written communication in German and English as well as strong experience in working with computer systems
• High degree of quality awareness, strong communication skills, and the ability to work in interdisciplinary teams
• Willingness to travel