QA Documentation Specialist

Company: Our client is a leading organization committed to maintaining the highest standards in quality and compliance within their regulated operations. They focus on ensuring safe and effective products through meticulous documentation and adherence to GMP guidelines.

Role Description: As a QA Documentation Specialist, you are responsible for verifying the accuracy and completeness of controlled batch documents and labels, ensuring compliance with quality standards and regulatory requirements, and supporting continuous improvement of documentation processes.

Responsibilities: Verify controlled batch documents and label packages, including final product labels, in accordance with cGMP standards. Confirm the accuracy and completeness of QA-issued documents and logbooks. Ensure timely use and proper management of GMP materials and consumables, informing the responsible personnel as needed. Identify and escalate compliance issues within the controlled issuance process. Support initiatives aimed at improving documentation procedures.

Investigate deviations related to controlled document issuance and develop effective corrective action plans. Perform additional duties as assigned, delegating tasks to qualified team members when necessary. Prioritize tasks to meet deadlines, demonstrating strong attention to detail and accuracy. Communicate effectively with colleagues at all levels, including senior stakeholders, and cross-train peers on documentation procedures. Maintain advanced technical knowledge of GMP processes and ensure clear presentation of documentation operations and guidelines.

Requirements: HBO or WO level education. At least 2 years of experience managing documents in a regulated environment. Strong command of English communication, both written and verbal. Positive attitude and a detail-oriented approach. Ability to work within a structured schedule, including working on weekends in a rotational pattern every six weeks, with adequate rest days.

Other Information: If you are interested and want to apply, please submit your application via the apply button below and contact me.