• Global MNC Biotechnology Companies
• Work location: West
• 1-year renewable contract with completion bonus

Responsibilities

• Supports facilities-related Compliance document management support.
• Supports turnkey and infrastructure projects on compliance document requirements.
• Responsible for ensuring strict adherence to Illumina 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.
• Provides value-added input and has a problem-solving attitude.
• Is able to function independently without constant monitoring and must be able to provide timely updates to the facilities compliance management

Requirements

• Min Diploma or Bachelor’s degree in Mechanical, Electrical, Pharmaceutical Engineering or equivalent disciplines.
• At least 3 - 5 years’ relevant working experience, preferably in Biotech, Biomedical, Pharmaceutical or Semiconductor facilities environment.
• Must have proficiency with various software applications programs including SAP PLM, SAP EAM, EtQ, BMS, EMS, MS Excel, Word and Powerpoint
• Demonstrates familiarity with regulatory guidelines and industry standards.
• Experience in document management strategies, process improvement initiatives and projects.
• Experience in establishing operational documents.
• Strong documentation bias and paramount attention to detail.
• Ability to work independently and with all levels.
• Must be committed and good team player.
• Demonstrates ability to communicate effectively and professionally with internal and external associates.
• Must be prepared to work overtime when necessary.

To apply, please visit to www.gmprecruit.com and search for Job Reference: 17889

To find out more about this opportunity, please contact Alexandra at: alexandra@gmprecruit.com

GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Alexandra Calingo | Registration No: R1101491