Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industriesPQE 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.
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 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 a new QA Validation Consultant to support a strategic project for a client in Taiwan.
You will be responsible for:
- Reviewing and approving CSV-related documentation, including URS, FS, risk assessments, validation plans, protocols, reports, and SOPs, ensuring alignment with GMP and data integrity requirements.
- Ensuring that computerized systems lifecycle documentation complies with applicable guidelines (e.g., GAMP 5, 21 CFR Part 11, Annex 11).
- Assessing deviations, changes, and nonconformities related to computerized systems and ensuring proper documentation, investigation quality, and CAPA effectiveness.
- Providing QA oversight during system implementation or maintenance phases, verifying that deliverables and documentation meet quality standards.
- Supporting audit readiness for CSV-related topics and participating in internal/external audit documentation reviews.
- Collaborating with cross-functional teams (IT, QA, Validation, Manufacturing, Supply Chain) to ensure consistent application of CSV principles.
- Supporting continuous improvement initiatives related to documentation quality, compliance, data integrity, and lifecycle management practices.
About you:
- Bachelor's Degree in a Scientific, Engineering, or IT-related discipline.
- 5-10 years of experience in QA, CSV compliance, or validation governance within GMP-regulated environments.
- Strong knowledge of GAMP 5, data integrity principles, Annex 11, 21 CFR Part 11.
- Experience in QA review of validation deliverables and computerized systems lifecycle documentation.
- Excellent analytical, compliance-oriented, and problem-solving skills.
- Strong communication skills and ability to interface with multiple stakeholders.
- English fluency (minimum B2).
- Chinese is a nice to have
Location: Taipei, Taiwan
Availability: 100 % on site
Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.
If there's a positive match, a technical interview with the Hiring Manager will be arranged.
In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.
Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.
Working at PQE Group
As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.
If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.
Apply now and take the first step towards an amazing future with us.
