Qualification Specialist (f/m/d)

TN Germany; Planegg; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading company in biopharmaceutical development is seeking a Quality Control expert to manage laboratory equipment in compliance with GMP standards. The role involves overseeing QC instruments, coordinating maintenance, and supporting audit readiness. Join a diverse team that values innovation and personal growth.

Qualifikationen

• 3-5 years of relevant pharmaceutical industry experience as a GMP technical expert.
• Experience with QC equipment qualification per GMP guidelines.

Aufgaben

• Compile and review SOPs, QC templates, and reports.
• Prepare QC laboratories for audits and inspections.
• Conduct instrument training and documentation.

Kenntnisse

Communication

Organizational Skills

Ausbildung

Bachelor's or equivalent degree in (bio)chemistry, biology, medical sciences, pharmacy

Tools

Electronic Data Processing

Jobbeschreibung

The provided job description contains relevant information but exhibits issues with redundancy, formatting inconsistencies, and excessive detail that could be streamlined for clarity. Below is a refined version that maintains all essential details while improving readability and structure:

Client:

Coriolis Pharma Research GmbH

Location:

Job Category:

Other

EU work permit required:

Yes

Job Reference:

61dd750f9eca

Job Views:

1

Posted:

11.05.2025

Expiry Date:

25.06.2025

Job Description:

Purpose of your Job

The role involves supporting the Quality Control (QC) unit by managing laboratory equipment in compliance with GMP standards. Responsibilities include overseeing QC instruments, coordinating maintenance and qualification, supporting audit readiness, executing routine QC tasks, reviewing documentation, and conducting instrument training to ensure efficient laboratory operations.

Your Responsibilities

• Compile and review SOPs, QC templates, and reports
• Prepare QC laboratories for audits and inspections
• Conduct instrument training and documentations
• Review instrument logbooks and performance documents
• Compile and organize (re)qualification documents for GMP systems
• Perform (re)qualification activities
• Manage GMP equipment systems
• Handle material and sample receipt documentation
• Perform routine QC tasks such as calibration and maintenance

Requirements to Succeed

• Bachelor's or equivalent degree in (bio)chemistry, biology, medical sciences, pharmacy, or related fields; MTA, BTA, CTA, or similar
• Experience with QC equipment qualification per GMP guidelines
• 3-5 years of relevant pharmaceutical industry experience as a GMP technical expert
• Proficient in English (written and verbal)
• Strong communication and organizational skills
• Deep knowledge of instrument qualification processes
• Proficiency in electronic data processing

Why Join Coriolis?

Join a team that values innovation, collaboration, and diversity. We offer an inspiring work environment at our Martinsried site, emphasizing personal growth and community. We are committed to equal opportunity and welcome applicants from all backgrounds.

Contact Information

Dominik Schwemmer
Senior Business Partner - Talent & Development
Coriolis Pharma Research GmbH
Phone: [phone]
Address: Fraunhoferstraße 18b, 82152 Martinsried
Website: www.coriolis-pharma.com

About Us

Coriolis Pharma is a global CRDO specializing in biopharmaceutical development, analytical, and manufacturing services across various modalities, including biologics and gene therapies. Our culture promotes diversity, teamwork, and open communication, with headquarters in Martinsried and a US-based team to serve our clients worldwide.