Job Title:         Sr Doc Control Administrator
 
Reports to:      Manager, QA
 
Department:     GSD Quality
 
Location:         Marsiling
 
Requisition ID: 118632BR
 
 
 
How Will You Make an Impact?
 
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com. 
 
 
 
What will you do?  

• Support Document Control Function in providing documentation and SAP, Agile and all relevant software system supporting Singapore operations. 
• Execute and maintain electronics database of workflow and procedures. Ensure close follow up of the status till closure.
• Process ECN/ECR/ECO/MCO in Agile for all engineering change management and working with the requester on the requirements.
• Send documents on PQF to vendor as necessary.
• Maintain and update Document Master and Record Retention List to meet requirements. This includes periodic audits to check on documentation/drawing inventory based on Good Document Practices.
• Ensure that systems and procedures are in compliance with ISO9001, ISO14001, ISO13485, ISO14971, FDA 21CFR Part 820, OHSAS 18001 and WHO Good Distribution Practices requirements. 
• Support QA/QC in change management this include QMS and product new release and changes based on approved and released documentation as define in respective process SOP and project responsibilities.
• Support plant-wide activities and special projects, assigned.

• Minimum “O” / "A" Level with 5-8 years of relevant working experience.
• Excellent communication skills to liaise with cross-functional teams and stakeholders of different levels.
• Detail-oriented.
• Comfortable to present in front of a small crowd or conduct regular meetings.
• Independent and proactive.
• Good to have knowledge or experience with ISO13485 or ISO9001.
• Good to have SAP experience.