We are currently seeking a dedicated and detail-oriented Quality Assurance professional with strong experience in sterile manufacturing and aseptic practices to join our team. This role offers a unique opportunity to play a key part in maintaining high-quality standards across the production of biologic drug products in a highly regulated GMP environment.

If you have a solid background in quality operations, a passion for compliance, and thrive in aseptic settings, we’d love to hear from you!


KEY RESPONSIBILITIES

• Ensure that all drug products, both commercial and investigational, meet the required quality standards prior to release.

• Verify that products and aseptic process simulations meet internal requirements, regulatory expectations, and end-user needs.

• Provide quality and compliance oversight to Operations, ensuring adherence to all relevant site procedures and policies.

• Maintain a strong presence on the manufacturing floor during aseptic operations, including oversight of aseptic interventions.

• Lead or assist in investigations stemming from process deviations or non-compliance.

• Review and audit completed batch manufacturing records and logs as necessary.

• Conduct quality reviews of operational documents, including SOPs, JSTMs, and risk assessments.

• Perform line clearance activities prior to production runs.

• Execute raw material checks and maintain product status as required.

• Support the Stability Program through sample pulls, weekly checks, and protocol preparation when needed.

• Maintain finished product status and oversee labeling activities.

• Administer quality-related logs (e.g., QA Hold, Sample Requests).

• Lead daily walkthroughs of manufacturing areas to support compliance and continuous improvement.

• Champion process simplification and continuous improvement within Operations to sustain compliance.

• Provide additional quality support as required.
  
  

KEY REQUIREMENTS

• Bachelor’s degree in a science, quality, or engineering discipline.

• Ideally, prior experience in a quality-focused role.

• Minimum of 2 years’ experience in a GMP-regulated quality or operations role. Experience in biologics manufacturing is highly desirable.

• Strong background in aseptic processing within a quality or manufacturing environment is highly preferred.

• In-depth knowledge of regulatory compliance standards is essential.
  
  

CORE SKILLS

• Exceptional attention to detail and ability to maintain accuracy under pressure.

• Strong analytical and problem-solving skills with adaptability to changing priorities.

• Innovative mindset with the ability to introduce and implement practical solutions.

• Results-oriented, consistently meeting performance targets and metrics.

• Committed to delivering high-quality outcomes and maintaining a Right First Time approach.

• Strong verbal and written communication skills.

• Excellent interpersonal skills and a collaborative approach.

• Demonstrates integrity, professionalism, and a strong work ethic.
  

EHS RESPONSIBILITY

• Complies with all EHS policies and procedures.

• Prioritises safety—personally and for others—by following guidelines and reporting hazards.

• Actively participates in the EHS program, including incident reporting and improvement suggestions.

• Completes all required EHS training and medical surveillance activities.

• Wears appropriate PPE at all times.