Quality Specialist (QA/QC)

Location: Singapore

Moleac is a biopharmaceutical company focused on addressing unmet medical needs by bringing innovative products to patients worldwide. With a dynamic, fast-paced, and mission-driven environment, Moleac is committed to improving health outcomes and delivering quality through excellence in our global operations.

We are seeking a Quality Specialist(QA/QC) to support product quality and Quality Management System (QMS) activities across our outsourced manufacturing and testing network.

This is a hands-on role supporting day-to-day QA/QC activities, including batch and analytical data review, product release, quality documentation, quality event management, supplier quality activities, and quality system improvement.

The Quality Specialist will work closely with CMC, Regulatory Affairs (RA), Supply Chain, contract manufacturers (CMOs), testing laboratories, and suppliers to ensure activities are performed in accordance with applicable quality requirements.

The role will also support the Senior Quality Specialist/Quality Manager in strengthening quality systems, identifying quality risks, and driving continuous improvement across the Supply Platform.

ESSENTIAL DUTIES & RESPONSIBILITIES

1. Quality System Support & Continuous Improvement

• Support the maintenance and implementation of the Quality Management System (QMS) for CMC and Supply Platform activities.
• Maintain quality documentation and records to support compliance and inspection readiness.
• Support preparation, review, and periodic updates of SOPs, specifications, analytical methods, forms, and other controlled documents.
• Support continuous improvement initiatives for quality processes, documentation, and ways of working.
• Maintain quality metrics, trackers, and data to support quality trending and management review.
• Perform and/or coordinate quality checks of outsourced manufacturing, testing, and distribution activities against applicable GMP/GDP and internal requirements.
• Identify quality gaps or risks and escalate them to the appropriate quality personnel.

2. External Partner & Supplier Quality Support

• Support quality oversight of contract manufacturers, testing laboratories, and material suppliers.
• Coordinate documentation required for qualification, onboarding, and periodic review of CMOs, laboratories, and suppliers.
• Support the preparation and maintenance of quality agreements.
• Maintain supplier and external partner quality documentation, including certifications, qualification records, audit documentation, and performance records.
• Track quality performance, observations, CAPAs, and follow-up actions with external partners.
• Communicate and coordinate routine quality matters with CMOs, laboratories, and suppliers.

3. Batch Release & Quality Review

• Review manufacturing batch records, Certificates of Analysis (CoA), laboratory testing reports, and other relevant quality documentation.
• Perform QC release activities for raw materials, packaging materials, intermediates, bulk products, and finished products in accordance with approved procedures and specifications.
• Verify that manufacturing and testing activities comply with approved specifications, methods, and applicable quality requirements.
• Maintain batch release trackers and ensure required quality documentation is complete and properly filed.
• Coordinate with Supply Chain and relevant stakeholders to support timely batch release.
• Identify discrepancies, deviations, or potential quality risks during review and escalate them for assessment.
• Support incoming material inspection and other quality control activities where required.

4. Analytical & Stability Program Support

• Coordinate analytical testing activities conducted by external laboratories.
• Maintain testing trackers and schedules to ensure timely completion of required analyses.
• Support stability programs, including sample coordination, schedule tracking, documentation, and review of stability data.
• Review analytical results against approved specifications and requirements.
• Support trending of analytical and stability results to identify potential quality trends, OOS/OOT results, or other concerns.
• Support preparation and review of stability protocols and reports in collaboration with CMC and Quality.

5. Quality Event Management

• Maintain and track deviations, OOS, OOT, investigations, CAPAs, and product complaints.
• Support investigations by collecting information, reviewing documentation, and coordinating follow-up actions with internal teams and external partners.
• Monitor CAPA implementation and completion against agreed timelines.
• Support effectiveness checks where required.
• Assist in assessing potential quality impact on materials, in-process products, and released batches.
• Support customer complaint investigations and documentation.
• Escalate significant quality events or recurring quality issues to senior Quality personnel.

6. Change Control, Qualification & Validation Support

• Support change controls related to manufacturing processes, analytical methods, materials, suppliers, laboratories, and product specifications.
• Coordinate and track implementation of approved changes with CMC, RA, Supply Chain, and external partners.
• Maintain qualification and validation documentation, including process validation, cleaning validation, and analytical method validation/verification records.
• Support review of qualification and validation documentation for completeness and compliance.
• Maintain change-control trackers and follow up on outstanding actions.

QUALIFICATIONS

• 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.
• Basic working knowledge of cGMP and pharmaceutical quality systems.
• Experience in QA/QC activities such as batch documentation review, laboratory testing, material inspection, deviations, CAPA, or change control is preferred.
• Experience working with contract manufacturers, suppliers, or external testing laboratories is advantageous.
• Familiarity with GDP requirements for distribution activities is an advantage.
• Good attention to detail and ability to review and maintain technical and quality documentation.
• Good coordination and communication skills for working with internal stakeholders and external partners.
• Good written and verbal communication skills. Ability to communicate with suppliers/manufacturers in China would be advantageous.

KEY COMPETENCIES

• Attention to detail and quality mindset.
• Good analytical and problem-solving skills.
• Ability to follow established procedures while identifying and escalating quality risks.
• Good organizational and task-management skills.
• Ability to manage multiple routine QA/QC activities and follow up on agreed timelines.
• Effective collaboration with CMC, RA, Supply Chain, and external partners.
• Clear communication and documentation skills.
• Willingness to learn and develop broader QA/QC and CMC quality capabilities.