Technical Specialist (Manufacturing Deviations/ Up to $7K/ Pharma MNC) #HAC

Recruit Express Pte Ltd; Singapore; Presencial; SGD 71 000 - 85 000; Tempo integral

Resumo da oferta

Recruit Express Pte Ltd is seeking a capable professional to lead end-to-end manufacturing deviation investigations in a GMP-regulated biopharmaceutical environment in Singapore. The role focuses on ownership from initiation through CAPA development and closure, utilizing RCA methods and cross-functional collaboration.

You will prepare GMP documentation, monitor timelines, and drive timely closure of deviations and CAPAs while supporting continuous improvement and regulatory compliance in

Qualificações

• Diploma or Degree in Biotechnology, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Life Sciences or a related discipline.
• Experience in biopharmaceutical manufacturing, preferably biologics, vaccines, API or drug substance.
• Strong hands-on experience leading end-to-end deviation investigations.
• Proven RCA, CAPA management and deviation closure experience.
• Good GMP understanding and shop-floor operations.
• Experience working with cross-functional stakeholders to resolve manufacturing issues.
• Strong technical writing and analytical skills.
• Familiarity with TrackWise or Veeva Vault is advantageous.
• Able to manage multiple investigations independently in a dynamic manufacturing environment.

Responsabilidades

• Lead end-to-end manufacturing deviation investigations in a GMP-regulated biopharmaceutical environment.
• Own investigations from initiation and root cause identification through CAPA development, implementation and closure.
• Conduct Root Cause Analysis (RCA) using methodologies such as 5 Whys and Fishbone Analysis.
• Facilitate cross-functional investigations with Manufacturing, QA, QC, MSAT and Engineering teams.
• Assess manufacturing deviations, process discrepancies and potential product quality impacts.
• Develop and monitor CAPAs, including effectiveness checks to prevent recurrence.
• Prepare technical investigation reports, assessments and supporting GMP documentation.
• Track investigation timelines and drive timely closure of deviations and CAPAs.
• Support deviation trending, recurring issue investigations and continuous improvement initiatives.
• Ensure compliance with GMP requirements, internal SOPs and regulatory standards.

Conhecimentos

RCA

CAPA management

GMP knowledge

Root cause analysis

Cross-functional collaboration

Technical writing

Formação académica

Biotechnology / Life sciences degree

Ferramentas

TrackWise

Veeva Vault

Descrição da oferta de emprego

Contract: 6 months (renewable / extendable)

Salary: Up to $7,000/month

Completion Bonus: 0.5-month completion bonus

Job Responsibilities

• Lead end-to-end manufacturing deviation investigations in a GMP-regulated biopharmaceutical environment.
• Own investigations from initiation and root cause identification through CAPA development, implementation and closure.
• Conduct Root Cause Analysis (RCA) using methodologies such as 5 Whys and Fishbone Analysis.
• Facilitate cross-functional investigations with Manufacturing, QA, QC, MSAT and Engineering teams.
• Assess manufacturing deviations, process discrepancies and potential product quality impacts.
• Develop and monitor CAPAs, including effectiveness checks to prevent recurrence.
• Prepare technical investigation reports, assessments and supporting GMP documentation.
• Track investigation timelines and drive timely closure of deviations and CAPAs.
• Support deviation trending, recurring issue investigations and continuous improvement initiatives.
• Ensure compliance with GMP requirements, internal SOPs and regulatory standards.

Job Requirements

• Diploma or Degree in Biotechnology, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Life Sciences or a related discipline.
• Prior experience in biopharmaceutical or pharmaceutical manufacturing, preferably in biologics, vaccines, API or drug substance manufacturing.
• Strong hands-on experience independently leading end-to-end manufacturing deviation investigations is essential.
• Proven experience in RCA, CAPA management, product impact assessments and deviation closure.
• Good understanding of GMP manufacturing processes, production equipment and shop-floor operations.
• Experience working with cross-functional stakeholders to resolve manufacturing issues.
• Strong technical writing, analytical and problem-solving skills.
• Familiarity with TrackWise, Veeva Vault or other electronic quality management systems is advantageous.
• Able to manage multiple investigations independently and work in a dynamic manufacturing environment.