Company
A leading global biotechnology organization dedicated to discovering, developing, and delivering innovative medicines for patients with serious illnesses. Driven by science and powered by advanced technology, the organization focuses on areas such as oncology, cardiovascular disease, inflammation, and rare diseases. Its mission is centered on improving lives by turning cutting-edge science into meaningful therapies that address unmet medical needs.
Job Description
We are seeking a detailed-oriented Senior Quality Assurance Associate to join the team. This role is responsible for reviewing and approving critical master data and artwork related to medicinal products, maintaining QA systems, and supporting compliance with GMP standards. The ideal candidate will work closely with various departments to ensure quality integrity and support continuous improvement initiatives.
Responsibilities
- Review and approve SAP master data and artwork for medicinal products to ensure accuracy and compliance.
- Maintain and improve QA systems, monitoring their performance regularly.
- Collaborate with the Global Artwork Center, Master Data, SCPM, site SMEs, Regulatory Affairs, and QA management to ensure seamless processes.
- Author, review, and approve operational SOPs and Work Instructions related to quality assurance procedures.
- Participate in QA projects and contribute to investigations when necessary.
- Screen, categorize, and resolve data integrity issues, ensuring compliance with regulatory requirements.
- Apply research and analytical skills to troubleshoot moderate technical problems and develop effective solutions.
- Recognize escalations and communicate potential issues proactively, supporting department goals.
Requirements
- Bachelor’s degree in Life Sciences or a related field; a Master’s degree is a plus, especially as an entry-level candidate.
- Minimum of 3 years’ experience in QA or manufacturing within the pharmaceutical or medical device industry.
- Knowledge of GMP, GDP, and GCP guidelines with the ability to interpret and apply them in routine scenarios.
- Strong communication skills and fluency in English.
- Precise, organized, and detail-oriented mindset.
Other Information
Apply to our vacancy for more information. Looking forward to getting in touch!
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