Job description
Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.
What is PQE Group?
Working in a consulting environment like PQE Group will offer you:
- The opportunity to work on projects for top national and international pharmaceutical companies, gaining cross‑functional skills and a broad perspective of the industry.
- The advantage of rapidly growing your professional experience thanks to the constant support of a multicultural team of professionals from different disciplines.
- The chance to develop your adaptability and project management abilities to quickly adjust to the dynamic nature of consultancy work, allowing you to face ever‑evolving challenges.
- Opportunities to travel both nationally and internationally.
Our Laboratory Excellence Team is experiencing significant growth, thanks to a constantly evolving market that continuously demands the high quality of our services. For this reason, we are looking to welcome new QC Microbiology Consultants to support a strategic project for a client in Taiwan.
Main responsibilities
- Perform and oversee microbiological validation activities on active raw materials, excipients, and packaging components, ensuring compliance with applicable GMP standards (e.g., PIC/S, ICH, EU GMP, US FDA guidelines).
- Draft, execute, and review microbiological validation protocols and reports, ensuring alignment with global regulatory expectations, including the principles of sterile manufacturing and contamination control.
- Conduct microbiological analyses for bioburden, sterility testing, endotoxin, and environmental monitoring, applying validated laboratory methods and compliant data‑integrity practices.
- Support the preparation, management, and continual improvement of microbiology‑related technical documentation, ensuring adherence to site procedures and multinational regulatory requirements.
- Collaborate with internal cross‑functional teams and external stakeholders to provide microbiology expertise, contributing to contamination control strategies and aseptic process assurance.
- Participate in deviation investigations, risk assessments, and CAPA activities related to microbiological quality topics.
About you
- Degree in scientific disciplines (Biology, Biotechnology, Microbiology, Chemistry, or related fields).
- At least 5 years of experience in a QC microbiology role, with specific skills in microbiological validation of active raw materials, excipients, and packaging materials.
- Excellent written and spoken English (minimum B2 level).
- Chinese is a nice to have.
- Strong analytical and problem‑solving skills.
- Excellent communication skills and a strong team‑oriented mindset.
Location
Nantou, Taiwan