We are seeking a QA Specialist to join our clients team. You will play a key role in supporting the delivery of high-quality products by working closely with internal teams, production sites, and external partners. Your efforts will help ensure that products meet required quality standards and align with organisational goals.
Key Responsibilities:
- Act as disposition manager ensuring that batch disposition activities are completed in line with the clients standards
- Manage and drive Quality records to closure including deviation records, investigation reports
- Initiate Quality records for supplier related changes.
- Collaborate with Complaints team to request assessments, reviews complaint report and have comments addressed
- Provide data to the networks to support Quality Management Processes)
- Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
- Take part in operational and quality improvement initiatives, programs, and projects.
- Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs.
Skills, Attributes and Experience:
- A degree in science, engineering, or a related discipline.
- Minimum of 4+ years experience working in QA in a cGMP manufacturing environment and a deep understanding of regulatory requirements.
- Direct experience in batch release activities and good working knowledge of SAP.
- Experience in investigations, project management, and trending/analysis.
- Relevant experience in Supplier Management (raw materials, packaging, devices) and understanding of manufacturing/testing processes (e.g., API, Drug Substance, Drug Product, Packaging, Device).
- Strong analytical, troubleshooting, and communication skills (verbal, written, presentation).
- Ability to work effectively with global, virtual teams and manage multiple priorities with high initiative.
- Team-oriented with a focus on achieving team goals.
- Proven ability to positively influence others.