Regulatory Quality Operations Specialist - Part-Time

Overview: Join a leading biopharmaceutical manufacturing environment and play a key role in ensuring quality system execution across manufacturing and production operations. The Quality Operations Specialist will support product quality oversight, compliance activities, batch release processes, investigations, and continuous improvement initiatives to ensure products meet regulatory and company quality requirements.

Location: Tuas, Singapore

Key Responsibilities:

Quality Oversight & Compliance

• Ensure products manufactured meet approved company policies, procedures, and quality standards.
• Provide quality oversight of GMP manufacturing, engineering, QC laboratory, supply chain, and technical operations activities.
• Conduct routine walk-throughs of manufacturing, engineering, warehouse, and QC areas to ensure compliance is maintained.

Batch Review & Product Release

• Review incoming material inspection packages, batch records, manufacturing logs, and quality documentation.
• Release incoming materials, processes, and product batches in accordance with quality requirements.
• Administer quality logs and quality-related documentation activities.

Investigations & Change Management

• Participate in investigations related to non-conformance, quality events, and manufacturing deviations.
• Support change management activities and ensure change plans comply with applicable policies and procedures.
• Collaborate with cross-functional teams to drive compliance and quality improvements.

Continuous Improvement

• Support new product introductions and operational excellence initiatives.
• Perform additional quality-related duties as assigned by management.

Requirements:

• Bachelor's Degree in Life Sciences, Biology, Chemistry, Pharmacy, Engineering, or a related discipline.
• 1–3 years of experience in pharmaceutical, biopharmaceutical, medical device, or GMP-regulated environments.
• Knowledge of quality systems, compliance management, and GxP regulations.
• Strong analytical, documentation, and problem-solving skills.
• Good communication and stakeholder management abilities

Preferred Skills:

• Experience with SAP and/or TrackWise.
• Knowledge of batch release and deviation management processes.
• Familiarity with pharmaceutical manufacturing operations.
• Strong planning and organisational skills.

We regret to inform that only shortlisted candidates will be notified.

Job Reference: R25150511 Cammy Li Xin Hui

Allegis Group Singapore Pte Ltd, Company Reg No. 200909448N, EA License No. 10C4544