1y Technical Specialist (Up to 4.2k, West) #HFT

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 84,000 - 110,000; Full time

Job summary

RECRUIT EXPRESS PTE LTD seeks a Technical Specialist to support Manufacturing operations in Readiness, Run and Release activities in Singapore. You will help prepare for technology transfers and process campaigns, drafting MBRs and CRs, coordinating risk assessments and pre-campaign trainings.

Degree in Biotechnology/Biomedical Science required, with strong understanding of manufacturing processes and equipment; experience in QA/ops is advantageous.

Qualifications

• Degree in Biotechnology/Biomedical Science.
• Experience in manufacturing/QA operations is advantageous.
• Good understanding of manufacturing processes and equipment.

Responsibilities

• Support Readiness activities for technology transfers and process campaigns (MBRs, CRs, docs, risk assessments, trainings).
• Assist Run activities including deviation assessments, CAPAs, CSCCs, rejected materials, and audits.
• Support Release activities with deviation investigations, root cause analyses, CAPAs and product impact assessments.

Skills

Manufacturing processes

Operational equipment knowledge

Education

Degree in Biotechnology/Biomedical Science

Job description

• The Technical Specialist will be responsible for supporting three key areas of Manufacturing operations – Readiness, Run and Release as assigned.
• Operational readiness activities for technology transfers and process campaigns include development/revision of Master Batch Records (MBRs), Change Requests (CRs), document creation/revisions, management of operational risk assessments, pre-campaign trainings and other associated tasks that are required prior to the start of process campaigns.
• Operational run activities include supporting assessments of Manufacturing deviations in DRB, managing CAPAs, tasks, CSCCs, rejected material management, participating in audits for deviation investigation topics and other associated tasks that are required during process campaigns.
• Operational release activities include leading deviation investigations and trend investigations alongside documentation of the root cause analysis, identification of appropriate Corrective and Preventive Actions (CAPAs) and product impact assessment that supports timely lot disposition.

Requirements

• Degree in Biotechnology/Biomedical Science
• Relevant manufacturing/process/QA operation experience would be advantageous
• The individual should have good understanding of manufacturing processes and operational knowledge of manufacturing equipment.