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.
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Due to our constant growth, we are looking for a Sterility Assurance Consultant to support our clients in Spain.
You will be responsible for
• Drafting corporate and site procedures for the management of key Sterility Assurance activities (e.g. environmental monitoring, cleaning & disinfection, gowning, CCS, APS).
• Preparation of Contamination Control Strategy (CCS) documents and related Contamination Risk Assessments.
• Performing risk assessments to define Sterility Assurance strategies, including but not limited to:
- Environmental monitoring plans
- Critical utilities monitoring plans
- Management of aseptic interventions
- APS worst-case scenarios
- Management of sterilizing filtration
• Drafting qualification and validation protocols and reports, such as:
- Cleanroom qualification
- Aseptic Process Simulations (APS)
- Aseptic operator qualification
• Management or support for microbiological contamination deviations.
• On-site support for Quality Assurance activities in sterile manufacturing environments (e.g. reduction of deviation backlog, management of change controls or CAPAs, oversight of APS or smoke studies).
• Preparation of training materials related to GMP, sterile manufacturing, hygiene and microbiology.
• Assessment of the compliance status of quality documentation against major regulatory standards in the field of Sterility Assurance.
About you
• University degree in a scientific discipline (Biology, Chemistry and Pharmaceutical Technologies, Pharmacy or similar). Knowledge in microbiology is considered a plus.
• At least 2 years of professional experience in Quality Assurance and Sterility Assurance within Life Sciences companies.
• Knowledge of the main sterile manufacturing processes in Life Sciences and related technologies (e.g. liquid and lyophilized dosage forms, biotech products – both drug substances and drug products, sterile API manufacturing).
• Experience with key GMP regulatory standards, with particular focus on EU GMP Annex 1 and Sterility Assurance guidelines.
• Experience in applying Quality Risk Management (QRM) principles and related risk assessment tools.
• Strong attention to quality and detail, analytical mindset, and problem-solving skills.
• Team-oriented attitude and ability to work in a dynamic, evolving environment.
• Excellent command of English, both written and spoken; knowledge of a second language is a plus.
• Willingness to travel: 40–60%
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. xohynlm 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.