1、Responsible for proposing and controlling the implementation of appropriate corrective and preventive actions at assigned suppliers as resulting from the audit observations. 2、Assess from the quality perspective any new source (e.g in the frame of New Product Developments) of APIs and Raw Materials, identifying potential challenges to be faced and working with the suppliers to overcome challenges within appropriate time in order to enable the new product implementation on the market. 3、Supports local organizations and BHC production sites for the proper supplier qualification by collecting and evaluating supplier’s documentation and by auditing. Acts as qualified lead auditor for the BHC compliance group A&S. 4、Responsible to coordinate audit needs with procurement, IPS and/or local organizations, NPD project teams and with the BHC compliance group A&S. 5、Acts as AIDA database compliance manager by establishing units, uploading, entering reports & follow up for assigned suppliers. 6、QA manager for divisionally managed suppliers/materials or suppliers/materials distributed through BCC AG 7、Coordinates failure investigation and CAPAs in case of deviations/complaints/Out of Specification for assigned suppliers. 8、Performs the regular GMP and/or GDP supplier evaluation in cooperation with CC sites and procurement for assigned suppliers. 9、Change management: QA member of the BCC API&raw material evaluation team Reviews, evaluates changes received from assigned suppliers, performs QA approval within the Change Management System Synaps, supports and controls change implementation. 10、Supports the creation and maintenance of QA agreements between BCC, API & Raw Material suppliers. 11、Acts as DaQS responsible for header data and qualification/certification process.

Education: The incumbent should have an advanced degree in chemistry, chemical engineering, pharmacy, pharmacology or equivalent scientific, medical or technical areas; a pharmacist license is an advantage. Profound knowledge in GMP regulations, quality systems, auditing. More than 3 years working experience in chemical or pharmaceutical industry or institute, production, quality management, with regulatory authorities, supplier or customer contact. Experience: Advanced know how on cGMP, ICH, IPEC and ISO as well as other relevant national and international quality assurance regulations for APIs, excipients, food and cosmetic ingredients. Practical experience in manufacturing and/or control of pharmaceutical ingredients. Competencies: Well developed interpersonal, intercultural, communication and networking skills for external and internal working contacts. For directing support to worldwide suppliers, good command of oral and written English are required. Additional language skills will be advantageous Work within different time zones and ability to travel is a pre-requisite. Solid computer skill in MS Office, internet, Lotus notes, and self-learning.