Quality Sampling & Materials Handling Associate (GMP/Pharma)

About the Role

This position offers a 12-month contract at a pharmaceutical manufacturing site located in Tuas, Singapore. The role involves ensuring that raw materials and consumables are sampled, handled, and documented in compliance with Good Manufacturing Practices (GMP) and data integrity standards, supporting the production of safe, high-quality pharmaceutical products.

Key Responsibilities

• Conduct sampling of raw materials, single-use technologies, and consumables according to approved SOPs and GMP requirements using validated techniques and tools to ensure representative and contamination-free samples.
• Properly label and document samples with relevant information such as batch numbers, dates, quantities, and storage conditions, and segregate samples accurately.
• Perform visual inspections during sampling and promptly report any deviations, abnormalities, or out-of-specification findings.
• Participate in investigations related to sampling deviations, out-of-specification results, or complaints, including root cause analysis and corrective action implementation.
• Maintain thorough sampling records and logs using electronic systems like LIMS or SAP, adhering to ALCOA+ data integrity principles.
• Ensure compliance with hygiene protocols, room disinfection, gowning requirements, and ongoing GMP training.
• Coordinate the receipt, quarantine, storage, and distribution of quality control samples under appropriate GDP and GMP storage conditions including temperature controls.
• Manage outbound shipments of samples to external labs, stability chambers, or contract manufacturers, preparing necessary documentation and ensuring proper packaging and transport coordination.
• Maintain inventory and reorder sampling consumables and logistics supplies as necessary.
• Support staging, kitting, and issuance of materials for manufacturing and quality control activities.
• Accurately perform transactions and maintain records in warehouse management systems (e.g., SAP EWM, iSHIFT) to track inventory and sample movement.

Required Qualifications and Experience

• Higher NITEC or Diploma in Pharmacy, Chemistry, Microbiology, Life Sciences, Biotechnology, or a closely related scientific or technical discipline.
• At least 2 to 5 years of practical experience in a GMP-regulated pharmaceutical, biotech, or life sciences environment, especially in quality control sampling, sample management, materials handling, warehouse operations, or logistics.
• Solid knowledge of current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), ALCOA+ data integrity principles, and applicable regulatory guidance such as ICH, WHO, or EU GMP Annexes.
• Proven experience with sampling techniques for raw materials and single-use technologies, including aseptic handling and cleanroom procedures where relevant.
• Familiarity with electronic documentation and transaction systems such as ERP (SAP), Laboratory Information Management Systems (LIMS), or similar platforms, and quick adaptability to new IT systems.
• Certified or trained in GMP/GDP fundamentals either internally or through recognized certifications (e.g., WHO GMP); additional expertise in cold-chain logistics, stability/expiry management, and material quarantine or release processes is beneficial.

Additional Information

The position is on-site at Tuas, Singapore. Salary can reach up to SGD 3,000 depending on candidate experience. This role involves adherence to strict procedures ensuring patient safety and the quality integrity of pharmaceutical products.

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