Apheresis Audit Manager, Pharmaceuticals, Remote work, 15M
800万円 - 1500万円
Working with Profession team in the market to develop your skills
Rewarding and challenging job will be provided
- An integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation.
- Contacting, coordinating, and scheduling an audit with the proper contacts at each Apheresis Collection center, including assembling the proper audit team, and determining travel logistics as needed.
- Complete and distribute an Audit Agenda, and Pre-Audit Document Request form to initiate
pre-audit document review
- Conduct audit at the apheresis site to ensure compliance to applicable regulations.
- Write the audit report within provided timelines, and issue reports along with Audit Findings
Response Plans and/or Audit Closure Memos
- Assess responses to audit observations and report all related metrics associated with each
- Contribute towards quarterly and annual audit program metrics
- Propose and implement improvements to the apheresis audit program.
- Support on-site cryostorage assessments and clinical to commercial site conversions.
- BS/BA degree with good experience at a pharmaceutical or biotechnology under a GMP/GTP/GQP environment, or healthcare experience directly related to apheresis-operations within a hospital or similarly regulated industry.
- Understanding of GMP and GTP regulations and "GCTP"
- In addition to strong communication skills (verbal and written), interpersonal skills, and organizational skills, the candidate must be able to work independently and productively from a remote position.
- Ability to travel up to 70% of the time, and at times, with limited notice
- 8M-15 JPY