Quality Specialist (QA/QC)

About the role

Moleac, a biopharmaceutical company, is looking for a Quality Specialist (QA/QC) in Singapore to support product quality and Quality Management System (QMS) activities across its outsourced manufacturing and testing network. This is a hands-on role covering batch and analytical data review, product release, quality documentation, quality event management, supplier quality and quality system improvement, working closely with CMC, Regulatory Affairs, Supply Chain, contract manufacturers, testing laboratories and suppliers.

Key responsibilities

• Support the QMS for CMC and supply platform activities, maintain quality documentation and records, and keep SOPs, specifications, analytical methods and forms up to date
• Perform and/or coordinate quality checks of outsourced manufacturing, testing and distribution against GMP/GDP requirements, and identify and escalate quality gaps and risks
• Oversee contract manufacturers, testing laboratories and suppliers, including qualification, quality agreements, audits, CAPAs and performance tracking
• Review batch records, CoAs and lab reports, perform QC releases, and coordinate timely batch release with Supply Chain
• Coordinate analytical testing and stability programs, track results, and support trending of OOS/OOT data
• Maintain and track deviations, OOS/OOT, investigations, CAPAs and product complaints, and support their resolution
• Support change controls, qualification and validation documentation, and maintain change-control trackers

Required profile

• Diploma or degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biotechnology or a related discipline
• 2-3 years of experience in pharmaceutical, biotechnology, quality control, quality assurance or another GMP-regulated environment
• Preferred: QA/QC experience such as batch documentation review, material inspection, deviations, CAPA or change control
• Advantageous: experience with contract manufacturers, suppliers or external labs; familiarity with GDP; ability to communicate with suppliers/manufacturers in China

Required skills

• Basic working knowledge of cGMP and pharmaceutical quality systems
• Good attention to detail, analytical and problem-solving skills
• Good written and verbal communication and coordination with internal stakeholders and external partners