Summary / Objective This position handles the quality requirements and standards for manufacturing products in a GMP-regulated environment. Being a hands-on person, the incumbent of this position will support the site quality system and procedures in alignment with the global group quality policies and applicable industry standards. The responsibilities will be focused on the operations of a state-of-the-art, clean, pharma packaging manufacturing environment.
Essential Functions • Supports the site in order to guarantee continuity of Quality systems and activities according to global and local standards and at acceptable cost. Partnering with operations to support site objectives. Find global balance between quality requirements, compliance and costs. • Supporst the Quality Management System: ensure the compliant status of the QMA with the requirements of ISO 9001 and ISO 15378. Provide interdepartmental assistance to ensure that controlled documents reflect current practice. Ensure proper document distribution and continually improve the flow of the documentation process. • Handles customer complaints, internal quality notifications, change control process, the CAPA process, and leads the investigations related to complaints and NCs. Define and implement quality related projects with the aim to significantly improve the Quality and/or compliance level. Liaise with relevant groups on site (e.g. operations, supply chain, engineering, etc.) and cooperate to come to a timely resolution of the mentioned QA processes. • Supports for internal and external audit performance (customers, regulatory agencies, ISO and suppliers) and follow up of the outcome (e.g. audit report, corrective actions, replies to external auditors and customers).
Additional Functions • Ensures the continuity and the compliance of the site's Quality Management System according to global and local standards (e.g. ISO 9001/15378, global group Quality procedures) and at acceptable cost. • Provides interdepartmental assistance to ensure that controlled documents reflect current practice. Ensure proper document distribution and continually improve the flow of the documentation process. • Coordinates customer complaints, including overseeing the investigation with the relevant departments in the site. • Processes and evaluates nonconformances and CAPAs. • Runs the local change control process. • Supports for internal and external audit performance (customers, regulatory agencies and suppliers) and follow up of the outcome (action plan). • Defines and implements quality related projects with the aim to significantly improve the Quality and/or compliance level. • Partners with operations to support site objectives. Find a good balance between quality requirements, compliance and costs. • Supports quality and continuous improvement activities as assigned by manager.
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任职要求
• Bachelor's Degree preferred. Science or engineering-related field a plus. • 3-5 years of relevant work experience in a QA role. • Experience with classified area's is preferred. • Thorough knowledge of cGMP regulations and current industry practice. • Knowledge of ISO 9001 and ISO 15378. • Strong analytical and technical writing skills • Good knowledge of domain-specific legislation, relevant standards and procedures. • Fluent in English, both verbal and written. • Experience in customer-facing role desirable.
