Quality Management and GMP Compliance Specialist

Jobtailor; Berlin; Vor Ort; EUR 65.000 - 100.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a Quality Assurance professional to support GMP-regulated pharmaceutical manufacturing environments. The role focuses on QA/QC collaboration, SOP creation and updates, risk assessment activities, and supporting audits and regulatory inspections.

The candidate will advise Haema locations on manufacturing- and quality-related topics, coordinate new process implementations, and ensure regulatory compliance across quality systems.

Qualifikationen

• Completed degree in pharmacy, chemistry, pharmaceutical chemistry and technology, biology, human medicine, or quality management.
• Initial professional experience in a GMP-regulated pharmaceutical manufacturing, QA/QC, or Quality Management environment.
• Good knowledge of GMP guidelines and regulatory requirements.
• Experience with quality-related documentation systems and MS Office applications.
• Strong analytical skills and a structured, solution-oriented approach to work.
• Excellent communication and consulting skills with stakeholders.

Aufgaben

• Support AMG function holders and the Quality Assurance department with quality-related questions and projects in a GMP-regulated environment.
• Coordinate and support the implementation of new processes, standards, and changes in manufacturing operations.
• Create, review, and update SOPs, work instructions, and other quality-related documents.
• Prepare and contribute to risk assessments, change control procedures, and validation/qualification activities.
• Support internal and external audits and regulatory inspections, and assist with implementing the resulting measures.
• Advise Haema locations on manufacturing- and quality-related topics.

Kenntnisse

Analytical skills

Communication skills

Collaboration

Consulting skills

Ausbildung

Degree in pharmacy, chemistry, pharmaceutical chemistry and technology, biology, human medicine, or quality management

Tools

MS Office

Jobbeschreibung

• Support AMG function holders and the Quality Assurance department with quality-related questions and projects in a GMP-regulated environment
• Coordinate and support the implementation of new processes, standards, and changes in manufacturing operations
• Create, review, and update SOPs, work instructions, and other quality-related documents
• Prepare and contribute to risk assessments, change control procedures, and validation and qualification activities
• Support internal and external audits and regulatory inspections, and assist with implementing the resulting measures
• Advise Haema locations on manufacturing- and quality-related topics

Requirements

• Completed degree in pharmacy, chemistry, pharmaceutical chemistry and technology, biology, human medicine, or quality management, or a comparable qualification
• Initial professional experience in a GMP-regulated pharmaceutical manufacturing, Quality Assurance, Quality Management, or Quality Control environment
• Good knowledge of relevant regulatory requirements, particularly GMP guidelines and quality-related processes
• Experience working with quality-related documentation systems and MS Office applications
• Strong analytical skills and a structured, solution-oriented approach to work
• Excellent communication and consulting skills, with the ability to collaborate effectively with a range of stakeholders

Core Competencies

Demonstrates expertise in Quality Assurance and Quality Management within a GMP-regulated environment, with a strong focus on regulatory compliance, documentation, and process improvement. Capable of effectively collaborating with stakeholders and supporting audits and inspections.

Highest-signal resume keywords

• GMP Regulatory Compliance
• Quality Assurance Experience
• SOP Development
• Risk Assessment
• Analytical Skills

ATS Optimization Keywords

Hard Skills

• Quality Management
• Quality Control
• Regulatory Requirements
• Documentation Systems
• Process Implementation

Soft Skills

• Communication Skills
• Consulting Skills
• Collaboration

Industry Keywords

• Pharmaceutical Manufacturing
• Quality-Related Processes
• GMP Guidelines

Tools & Technologies

• MS Office Applications