This role will work closely with Production, Quality Control, Engineering and Regulatory teams to support compliance, batch disposition activities, investigations, continuous improvement initiatives and audit readiness within a highly regulated sterile manufacturing environment.
Key Responsibilities
Quality Assurance Oversight
- Provide QA support to manufacturing and operational teams
- Ensure products are manufactured in accordance with cGMP requirements, company procedures and regulatory expectations
- Act as a Quality representative for assigned manufacturing processes and systems
- Provide guidance and support on quality-related issues across operations
- Review batch documentation to ensure completeness, accuracy and compliance
- Support batch release activities and final product disposition
- Ensure timely review and approval of production records and associated documentation
- Escalate and investigate quality concerns impacting product disposition
- Review and approve: Deviations, CAPAs, Change Controls, Quality Events, Investigations
- Ensure quality records are completed accurately and within required timelines
- Support root cause analysis and effectiveness checks
- Ensure compliance with GMP, GDP and company quality systems
- Maintain inspection and audit readiness
- Participate in internal, customer and regulatory audits
- Support responses to audit observations and implementation of corrective actions
- Drive quality improvements across manufacturing operations
- Analyse quality trends and recurring issues
- Support implementation of continuous improvement initiatives
- Monitor quality metrics and report performance indicators to management
- Partner closely with: Manufacturing, Quality Control, Engineering, Validation, Supply Chain
- Support timely closure of investigations and quality actions
- Promote a proactive quality culture across the site
- Bachelor's Degree in Science, Engineering, Biotechnology, Microbiology, Chemistry or related discipline.
- Previous experience within a GMP-regulated manufacturing environment.
- Experience working within Quality Assurance, Quality Control or Manufacturing Support functions.
- Experience reviewing quality documentation and investigations.
- Strong communication and stakeholder management skills.
- Excellent attention to detail and problem-solving abilities.
- Experience within pharmaceutical, biotechnology or sterile manufacturing environments.
- Previous exposure to: Aseptic processing, Sterile manufacturing, Biologics production, Lyophilisation processes
- Experience managing: Deviations, CAPAs, Change Controls, Audit responses
- Knowledge of FDA, HPRA, EMA or other regulatory requirements
- Experience with electronic quality management systems (eQMS)
- Ability to work effectively in a fast-paced manufacturing environment
- Strong analytical and investigation skills
- Ability to influence cross-functional stakeholders
- Team-oriented approach with a continuous improvement mindset
- Ability to balance compliance requirements with operational priorities
At Arcadis, we empower individuals to excel because your contributions matter. Taking a skills-based approach, we provide opportunities for you to shape your career, maximize your impact, and grow professionally. By joining us, you’ll engage in meaningful work that drives sustainable solutions for a better planet while leaving a lasting legacy. Our Commitment to Equality, Diversity, and Inclusion We are dedicated to creating an environment where everyone can thrive. Through our six ED&I workstreams—Age, Disability, Faith, Gender, LGBT+, and Race— we foster innovation by bringing together diverse perspectives. Together, we strive to improve quality of life while building a more inclusive future.
