Senior QC Analytical & Microbiology Lead
No deviation Pte Ltd
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Job summary
No deviation Pte Ltd is seeking a QC Analytical/Microbiology Lead to direct all QC analytical chemistry and microbiology activities across project execution and operational readiness. You will shape sampling strategies for process validation, utilities and water/WFI systems qualification, environmental monitoring, and cleaning validation.
As the SME for QC analytics, you will oversee method transfer and validation, equipment readiness, SOPs, and sampling plans, ensuring cGMP/data integrity and
Qualifications
- Bachelor's or master's degree in a related scientific discipline.
- Minimum 8+ years in pharma/biotech/biologics/sterile manufacturing.
- Experience across QC Analytical Chemistry and Microbiology functions.
- Experience supporting qualification, validation, PPQ, and commercial manufacturing.
Responsibilities
- Lead QC analytical and microbiology sampling to support project execution and readiness.
- Develop sampling strategies for process validation, utilities qualification, water/WFI systems, environmental monitoring, and cleaning validation.
- Coordinate lab activities across commissioning, qualification, PPQ, and manufacturing start-up.
- Oversee method transfer, verification, qualification, and validation programs.
- Lead quality investigations (OOS/OOT/deviations/CAPAs) and drive corrective actions.
- Collaborate with CQV, Manufacturing, Engineering, MSAT, Validation, and QA across projects.
Skills
Education
Job description
No deviation Pte Ltd is seeking a QC Analytical/Microbiology Lead to direct all QC analytical chemistry and microbiology activities across project execution and operational readiness. You will shape sampling strategies for process validation, utilities and water/WFI systems qualification, environmental monitoring, and cleaning validation.
As the SME for QC analytics, you will oversee method transfer and validation, equipment readiness, SOPs, and sampling plans, ensuring cGMP/data integrity and
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