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Osaka, Japan

 

GMP Compliance Expert

Requested Languages:

English  Japanese
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job at pqe

PQE Group is a Contract Quality Organization and a Complete Quality Solution provider for GCP, GLP, GMP & GDP areas in the Life Science Industry. Since 1998, we have successfully completed more than 7,000 projects worldwide and now serve our Clients from offices in Italy, Spain, Switzerland, Germany, LATAM, USA, the Middle East, China, India and Japan. As an international group we have experience working in more than 25 languages and have an excellent history of supporting small, medium and large size companies exceeding compliance standards from the FDA / EMA / WHO / TGA / SFDA / ANVISA / INVIMA / GILS and other local authorities. PQE Group offers turnkey quality solutions and focuses on offering exceptional cost effectiveness, whilst maintaining highest quality standards for our Clients.

Due to a constant growth, we are looking for a GMP COMPLIANCE EXPERT.

In this full-time role, the Expert will participate in GMP Compliance projects, such as support to clients for Health Authorities inspection readiness or post inspection remediation programs, Quality Management System improvement initiatives and Quality Assurance tasks. The Expert will work alone or more frequently as part of multidisciplinary teams (either as leader or team member), depending on the nature and complexity of the project.



    MAIN AREA OF EXPERTISE:
  • 5+ years’ experience in pharmaceutical industries
  • Direct management of Health Authority inspections, from preparation to post-inspection phase
  • General knowledge of Pharmaceutical processes and deep knowledge of Finished Dosage Forms manufacturing practices (e.g. Oral Solid, Liquid, Sterile, Biotech)
  • Experience in Aseptic Environment
  • Expert in Quality tasks (e.g. PQR, Auditing, Change Control, Complaints, Deviations, CAPAs, OOS, Batch Record review, Documentation management, Training, Supplier Management)
  • Expert in Validation (i.e. Cleaning, Process)
  • Expert in executing Risk Assessment (e.g. Process, Cross-Contamination)
    EDUCATION:
  • Bachelor’s degree in Physical and Mathematic science (preferred Chemistry, Biotechnology, Microbiology, Biology, Pharmaceutical Technologies)
    SKILLS REQUIRED:
  • Leadership
  • Team work
  • Relational & communication skills
  • Project management
  • Resource management
  • Proven analytical and problem solving skills
  • Prioritization skills
  • Strong work ethic
    SPOKEN LANGUAGES:
  • Fluent English (at least B2/C1) Level
    OTHER REQUIREMENTS:
  • Availability to travel domestically and abroad
  • Excellent use of major productivity SW (e.g.: MS Office)

Full-Time Job

If interested, please send your resume in English, clicking on "Apply Now" button on this page.
Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.


job at pqe