QA Manufacturing Compliance Specialist

PSC Biotech® Corporation; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading biotech company in Singapore is looking for a QA Manufacturing Compliance Specialist. The role includes ensuring that products meet strict quality compliance in both marketed and investigational drug categories. Candidates should have a third level qualification in science, quality, or engineering, with at least 3 years of experience in a pharmaceutical or sterile manufacturing environment. Strong regulatory knowledge and excellent communication skills are required to succeed in this position.

Qualifications

• Minimum 3 years' experience in a similar role in a Pharmaceutical or Sterile Manufacturing environment (Biologics desirable).
• Strong knowledge of regulatory requirements is mandatory.
• Excellent written and verbal communication skills with strong attention to detail.

Responsibilities

• Ensure all products meet required standards for marketed and investigational drug products.
• Provide quality and compliance oversight to ensure manufacturing activities comply with site policies.
• Provide quality oversight during aseptic processing activities.
• Lead or assist investigations from non-compliance instances.
• Review and audit completed batch records.

Skills

Knowledge of regulatory requirements

Attention to detail

Written communication

Verbal communication

Education

Third level qualification in science, quality or engineering

Job description

About the job

We are recruiting for a QA Manufacturing Compliance Specialist to join the team. This position will report to the Quality Operations Lead and support the Quality Assurance team. The QA Manufacturing Compliance Specialist is responsible for documenting and establishing a quality system to ensure full compliance with all regulatory and internal requirements.

The QA Manufacturing Compliance Specialist will also be responsible for assessing and reporting on the effectiveness of the quality system to senior management.

What you will do:

• Ensure all products released meet the required standards for marketed and investigational drug products.
• Ensure products and aseptic process simulations meet end‑user, regulatory, and internal requirements.
• Provide quality and compliance oversight and support to Operations to ensure manufacturing activities comply with site policies and procedures.
• Provide quality oversight during aseptic processing activities, including observation of aseptic interventions.
• Lead or assist investigations arising from product or manufacturing process non‑compliance.
• Review and audit completed batch records.
• Review manufacturing logs as required.
• Perform quality review of operations documentation, including SOPs, JSTMs, and risk assessments.
• Complete line clearance activities.
• Perform incoming raw material checks, including product status maintenance, as required.
• Provide stability program support, including sample pulls, routine checks, and protocol generation, as required.
• Maintain finished product status, including labelling, as required.
• Administer quality logs such as QA Hold and Sample Request logs.
• Lead daily operations floor walk‑arounds of manufacturing areas.
• Drive continuous improvement initiatives and process simplification within Operations to ensure ongoing compliance.
• Provide additional support as required.

Qualifications

• A third level qualification in a science, quality or engineering discipline
• Minimum 3 years’ Experience in a similar role in a Pharmaceutical or Sterile Manufacturing environment (Biologics desirable)
• A strong knowledge of regulatory requirements is required.
• Excellent written and verbal communication skills with a strong attention to detail.