Pharmaceutical Technical Specialist 1 Year Contract #HJH

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 55,000 - 85,000; Full time

Job summary

RECRUIT EXPRESS PTE LTD is seeking a Technical Specialist to support three key areas of Manufacturing operations – Readiness, Run and Release. You will implement Master Batch Records (MBRs) and Change Requests (CRs), manage deviations and CAPAs, and perform root cause analysis with strong communication and technical writing skills.

The role requires a diploma or degree in Chemical Engineering, Biotechnology, Bioengineering, or Pharmaceutical Science, and availability on short notice.

Qualifications

• Hands-on deviation investigation experience.
• Strong root cause analysis (RCA).
• CAPA identification and follow-up.
• Available within a short notice period.

Responsibilities

• Operational readiness activities for technology transfers and process campaigns (MBRs, CRs, document revisions, risk assessments, pre-campaign trainings).
• Operational run activities including assessment of manufacturing deviations, CAPAs, and audits during process campaigns.
• Operational release activities including deviation investigations, root cause analysis, CAPA determination and product disposition.
• Demonstrates strong communication, presentation and technical writing skills and adapts to changing priorities.

Skills

Root cause analysis

CAPA identification

Deviation investigation

Technical writing

Communication

Education

Diploma/Degree in Chemical Engineering / Biotechnology / Bioengineering / Pharmaceutical Science

Job description

About the role

The Technical Specialist will be responsible for supporting three key areas of Manufacturing operations – Readiness, Run and Release as assigned.

Key responsibilities

• 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.

• The individual should have good understanding of manufacturing processes and operational knowledge of manufacturing equipment. Additionally, the individual should also have excellent communication, presentation as well as technical writing skills and should be able to demonstrate agility with changing priorities on deliverables.

Requirements:

• Min. Diploma/Degree in Chemical Engineering / Biotechnology / Bioengineering / Pharmaceutical Science or related
• Hands-on deviation investigation experience
• Strong root cause analysis (RCA)
• CAPA identification and follow-up
• Available within a short notice period