GMP Manufacturing Ops Specialist | Tech Transfer & CAPA

No deviation Pte Ltd

Singapore

On-site

SGD 70,000 - 110,000

Full time

14 days+

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Benefits offered by this job

Generous leave

Health & dental coverage

Professional development

Inclusive culture

Career impact

Job summary

No deviation Pte Ltd is seeking a Technical Specialist, Manufacturing Operations to provide technical and regulatory compliant support across the manufacturing lifecycle in Singapore. You will partner with Manufacturing, Quality, MSAT, Engineering and Supply Chain to ensure readiness, run campaigns, and support timely product release in a GMP environment.

The role emphasizes deviation investigations, CAPA management, change control and technology transfer support, with opportunities to lead

Qualifications

Bachelor's degree in Biotechnology, Life Sciences, Biochemical/Chemical Engineering, Pharmaceutical Sciences, Microbiology or related field.
3-8 years of GMP pharmaceutical/biotech manufacturing experience.
Experience supporting manufacturing operations, quality systems, or technical operations.

Responsibilities

Operational Readiness: support technology transfers, new product introductions, and campaigns; develop and manage MBRs; process CRs and GMP docs; support risk assessments and pre-campaign training.
Operational Run: manage deviations via DRB; lead CAPAs; track tasks and compliance commitments; assist investigations and materials disposition; participate in internal/external audits; drive cross-functional issue resolution.
Operational Release: lead deviation and trend investigations; perform root cause analyses; support batch disposition; verify CAPA effectiveness; ensure GMP compliance and timely product release.