Key Skills

Job Description

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 detail-oriented Quality Assurance Associate to join our client's team for 6 months. This role involves reviewing and approving critical GMP documentation and artwork, ensuring compliance with regulatory standards, and supporting quality process improvements within the organization. Responsibilities Review and approve SAP Master Data and artwork related to medicinal products. Collaborate with global teams, including Artwork Center, Master Data, SCPM, site SMEs, and QA management. Verify critical values and Bill of Materials during Master Data activities. Review operational SOPs and Work Instructions. Prepare and maintain weekly and monthly quality metrics. Manage departmental performance boards. Recognize and escalate potential problems, setting priorities for ongoing projects. Requirements BSc or MSc degree in Life Sciences or related field. 1+ years of QA or manufacturing experience within the pharmaceutical or medical device industry. Knowledge of GMP, GDP, and/or GCP regulations, with the ability to interpret and apply them in routine situations. Fluency in English. Accurate and detail-oriented mindset. Good communication skills. Eager to learn. Other Information The company will provide trainings for Artwork review and other internal processes. If you are interested and want to apply, please submit your application and contact me.

Core Responsibilities

Review and approve SAP Master Data, medicinal product artwork, critical values, and Bills of Materials while ensuring compliance with applicable quality and regulatory requirements. Collaborate with global teams, review operational procedures, maintain quality metrics and performance boards, and identify and escalate potential issues.

Requirements

A BSc or MSc in Life Sciences or a related field and at least one year of QA or manufacturing experience in the pharmaceutical or medical device industry are required. Candidates should understand GMP, GDP, and/or GCP regulations, communicate well in English, and be accurate, detail-oriented, and eager to learn.