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Descripción de la vacante
A Life Sciences consulting company in Singapore is seeking a candidate for a quality control microbiology role. You will handle sampling and testing of raw materials while ensuring compliance with GMP and GDP regulations. The ideal applicant should have a Degree or Diploma in Science or a related field and 1-3 years of experience in a pharmaceutical or biologics setting. Strong problem solving and organizational skills are essential.
Formación
1–3 years of experience in QC microbiology within pharmaceutical/biologics/sterile manufacturing.
Knowledge of GMP, GDP, aseptic technique, and relevant pharmacopeial methods.
Responsabilidades
Contribute to Life Science projects for clients.
Perform sampling of raw materials under controlled conditions.
Execute analytical and microbiological testing of raw materials.
Review supplier CoAs and perform verification testing.
Document activities in compliance with GDP and cGMP.
Support qualification of new raw material suppliers.
Participate in equipment qualification and method validation.
Assist in investigation of OOS/OOT results.
Ensure adherence to safety and contamination control requirements.
Contribute to continuous improvement of QC workflows.
Conocimientos
Problem solving
Analytical skills
Organizational skills
Communication skills
Educación
Degree/Diploma in Science, Microbiology, Biotechnology, Life Sciences
Descripción del empleo
Job Description
Overview of responsibilities below.
Responsibilities
Contribute to Life Science projects for Antaes Asia clients
Perform sampling of raw materials under controlled conditions (classified and non-classified areas).
Execute analytical and/or microbiological testing of raw materials as per approved methods (e.g. ID, purity, pH, conductivity, endotoxin, bioburden, compendial tests).
Review supplier CoAs and perform verification testing against specifications and pharmacopeias
Document all activities and data in compliance with GDP and cGMP requirements.
Support qualification of new raw material suppliers and material change controls.
Participate in equipment qualification, method verification/validation and periodic review of raw material specifications.
Assist in investigation of OOS/OOT results, deviations, and support CAPA implementation.
Ensure adherence to safety, material handling and contamination control requirements during sampling and testing.
Contribute to continuous improvement of raw material release processes and QC workflows.
Contribute to the promotion of Antaes services on top of assistance provided to client.
Job Requirements
Degree/Diploma in Science, Microbiology, Biotechnology, Life Sciences or related field.
1–3 years of experience in QC microbiology within pharmaceutical / biologics / sterile manufacturing environment preferred.
Knowledge of GMP, GDP, aseptic technique, sterility assurance, and relevant pharmacopeial methods
* El índice de referencia salarialse calcula en base a los salarios que ofrecen los líderes de mercado en los correspondientes sectores. Su función es guiar a los miembros Prémium a la hora de evaluar las distintas ofertas disponibles y de negociar el sueldo. El índice de referencia no es el salario indicado directamente por la empresa en particular, que podría ser muy superior o inferior.