Quality Control Raw Materials Consultant

ANTAES ASIA PTE. LTD.; Singapore; On-site; SGD 50,000 - 70,000; Full time

Job summary

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.

Qualifications

• 1–3 years of experience in QC microbiology within pharmaceutical/biologics/sterile manufacturing.
• Knowledge of GMP, GDP, aseptic technique, and relevant pharmacopeial methods.

Responsibilities

• 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.

Skills

Problem solving

Analytical skills

Organizational skills

Communication skills

Education

Degree/Diploma in Science, Microbiology, Biotechnology, Life Sciences

Job description

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
• Good problem solving and analytical skills
• Excellent organizational and communication skills