Quality Assurance Auditor III (GCP)
🔍 Warsaw, Poland, Poland
Brussels, Belgium, Belgium
Cluj-Napoca, Romania, Romania
Copenhagen, Denmark, Denmark
Budapest, Hungary, Hungary
Winchester, United Kingdom, United Kingdom
Samorin, Slovakia, Slovakia
Kiev, Ukraine, Ukraine
Lisbon, Portugal, Portugal
Madrid, Spain, Spain
Segrate (MI), Italy, Italy
Zagreb, Croatia, Croatia
Sofia, Bulgaria, Bulgaria
Athens, Greece, Greece
Ivry-sur-Seine Ced, France, France
Bellshill, United Kingdom, United Kingdom
Bennekom, Netherlands, Netherlands
Cambridge, United Kingdom, United Kingdom
Belgrade, Serbia, Serbia
Praha 4, Czech Republic, Czech Republic
Athlone, Ireland, Ireland
Bucharest, Romania, Romania
Rixensart, Belgium, Belgium
Zaventem, Belgium, Belgium
Required qualifications:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous GCP QA experience that provides the knowledge, skills, and abilities to perform the job (5+ years) ) or equivalent combination of education, training, & experience.
Preferred Experience, knowledge, skills, and abilities:
- Able to demonstrate proficiency and lead a range of project based or internal GxP audits and vendor audits to high standards required by management
- Excellent oral and written communication skills (English)
- Strong problem solving, risk assessment and impact analysis abilities
- Solid experience in root cause analysis
- Flexible and able to multi-task and prioritize competing demands/work load
- Able to conduct and/or lead a variety of client, internal or GCP audits and regulatory inspection support as requested by senior management
- Able to lead directed site audits and/or sub-contractor audits
- Able to provide GCP consultation and support to PPD project teams and external clients
- Able to participate as a co-auditor in more complex system audits
- Able to serve as a resource to operational departments on audit or quality assurance subject matter
- Able to prepare and present audit findings and/or other related information at departmental, internal operations or client meetings
- Candidates with directed audit, pre-inspection audit and inspection support experience are preferred.
- Thorough knowledge of GCP and appropriate regional research regulations and guidelines- Able to demonstrate proficiency and lead a range of project based or internal GxP audits and vendor audits to high standards required by management
- Excellent oral and written communication skills (English)
- Strong problem solving, risk assessment and impact analysis abilities
- Solid experience in root cause analysis
- Flexible and able to multi-task and prioritize competing demands/work load
- Able to conduct and/or lead a variety of client, internal or GCP audits and regulatory inspection support as requested by senior management
- Able to lead directed site audits and/or sub-contractor audits
- Able to provide GCP consultation and support to PPD project teams and external clients
- Able to participate as a co-auditor in more complex system audits
- Able to serve as a resource to operational departments on audit or quality assurance subject matter
- Able to prepare and present audit findings and/or other related information at departmental, internal operations or client meetings
In order to apply, please submit your CV in English. PPD is an equal opportunity employer.