Manufacturing QA Specialist - Deviation & Process Campaigns

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 67,000 - 100,000; Full time

Job summary

Recruit Express PTE LTD is seeking a Technical Specialist to be outsourced to clients in Singapore. You will support operational readiness for technology transfers, develop and revise MBRs, and manage CRs to ensure smooth campaigns.

In Operations Run and Release you will help assess deviations, lead investigations, document root causes and implement CAPAs, enabling timely lot disposition under a 1-year contract. A degree with relevant manufacturing/QA experience is required.

Qualifications

• Degree holder with relevant experience in manufacturing, process or QA operations.
• Strong experience in deviation investigation is compulsory.
• Able to commit to a 1 year contract.

Responsibilities

• Support operational readiness activities for technology transfers and process campaigns.
• Develop and revise Master Batch Records (MBRs).
• Manage Change Requests (CRs) and document creation/revisions.
• Manage operational risk assessments.
• Support pre-campaign trainings and other activities required before process campaigns.
• Support assessments of Manufacturing deviations in DRB.
• Manage CAPAs, tasks, CSCCs and rejected material management.
• Participate in audits for deviation investigation topics.
• Support other activities required during process campaigns.
• Lead deviation investigations and trend investigations.
• Document root cause analysis and identify appropriate CAPAs.
• Conduct product impact assessments to support timely lot disposition.
• Support three key areas of Manufacturing operations - Readiness, Run and Release as assigned.

Skills

Deviation investigation

Manufacturing operations

QA operations

Education

Bachelor's degree

Job description

Recruit Express PTE LTD is seeking a Technical Specialist to be outsourced to clients in Singapore. You will support operational readiness for technology transfers, develop and revise MBRs, and manage CRs to ensure smooth campaigns.

In Operations Run and Release you will help assess deviations, lead investigations, document root causes and implement CAPAs, enabling timely lot disposition under a 1-year contract. A degree with relevant manufacturing/QA experience is required.