- Supports facilities-related Compliance document management support.
- Supports turnkey and infrastructure projects on compliance document requirements.
- Responsible for ensuring strict adherence to company’s guidelines for document management strategies and document control.
- Collaborates with Quality, Life Cycle Management and other functions as needed.
- Engages Facilities Operations, Project and Engineering team to fulfill all required Compliance requirements.
- Supports the compliance effort either in reviewing documentation or executing periodic uploads to the QMS systems used at the site.
- Curates all Facilities documents for Compliance requirements based on direction from the facilities compliance team.
- Develop processes to manage and curate all department related documents by adopting a risk-based approach.
- In depth knowledge in Biotech’s practice and standards especially related to MDSAP regulations, ISO 13485:2016 and 21 CFR Part 11 and Part 820 and how these standards apply to facilities and/or utility systems.
- 3 - 5 years’ relevant working experience, preferably in Biotech, Biomedical, Pharmaceutical or Semiconductor facilities environment.
- Demonstrates familiarity with regulatory guidelines and industry standards.
- Experience in document management strategies, process improvement initiatives and projects.
- Strong documentation bias and paramount attention to detail.
- Demonstrates ability to communicate effectively and professionally with internal and external associates.
- Must be prepared to work overtime when necessary.
- Must have proficiency with various software applications programs including SAP PLM, SAP EAM, EtQ, BMS, EMS, MS Excel, Word and Powerpoint.
To find out more about this opportunity, please contact Lionel Liew at email@example.com.
We regret that only shortlisted candidates will be notified.
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Lionel Liew | Registration No: R1330693