Quality Assurance Specialist
SKILLS
FULL DESCRIPTION
Exciting opportunity has arisen for an experienced Quality Assurance (QA) professional to join a leading global biopharmaceutical organization within their Global Development Quality group. In this pivotal role, you’ll be exposed to a wide range of investigational medicinal products - from small molecules to advanced immunotherapies - playing a key part in ensuring these life-changing medicines reach patients safely and compliantly.
Overview
As a Quality Specialist, you will be responsible for the final review of clinical batch records, ensuring GMP compliance and alignment with regulatory filings. You’ll compile and approve data packs for presentation to the Qualified Person (QP) for final release, collaborating closely with global teams across the clinical supply chain and manufacturing sites worldwide. This position offers the chance to work independently in a dynamic, fast-paced environment where attention to detail, strong communication, and problem-solving skills are essential.
Key Responsibilities
- Review clinical batch records and supporting documentation to ensure compliance with GMP and regulatory standards.
- Compile and approve data packs for QP release of clinical trial materials.
- Conduct or support audits of data, processes, systems, and facilities to ensure ongoing GMP compliance.
- Review and approve production and analytical documentation for product release.
- Communicate audit findings, issue reports, and support remedial actions with relevant departments.
- Collaborate with internal and external global teams to maintain compliance and support the clinical supply chain.
Experience & Skills
- Experience in pharmaceutical, biotech, or regulatory agency QA roles with a solid understanding of cGMP regulations.
- Strong attention to detail with excellent written and verbal communication skills.
- Ability to work independently and manage issue resolution effectively.
- Skilled in documentation review, audit preparation, and regulatory compliance.
Qualifications
- Bachelor’s degree or higher in a scientific discipline (Chemistry, Biology, Pharmacy, or related field).
- Prior QA or GMP experience preferred, but applications are also welcomed from ambitious science graduates with a strong desire to develop in a pharmaceutical quality environment.
Employment details
- Seniority level: Associate
- Employment type: Full-time
- Job function: Quality Assurance
- Industries: Pharmaceutical Manufacturing and Biotechnology Research