Our client is a global pharmaceutical company and offers you a responsible challenge as Supply Quality Expert in a dynamic enterprise.
Duties:
Manage the strategical and tactical quality aspects of PharmOps CH external suppliers and contract manufacturers. Ensure that the supplier/contract manufacturer operates and to continues to operate in compliance with cGMP and regulatory requirements, the Quality Agreement, the Companys Quality Manual and relevant SOPs.
This role requires adherence to specific cGMP requirements and execution according to the valid SOP’s.
- Provide direction, formulate strategies and make decisions which ensure the efficient operation of the supplier/contract manufacturer business as a whole
- Ensure that all aspects of the handling, manufacturing and distribution of supplied products are in compliance with the Companys Quality Manual, the effective Quality Agreement, that they meet relevant cGMP regulatory requirements and are conducted according to local SOPs
- Drive / initiate Supplier/Third Party Quality Risk assessments are carried out for all suppliers. Identify gaps of Quality Systems with an evaluation of the associated risks. Define remediation plans and monitor and execution to ensure that issues are suitably addressed
- Ensure that a valid Quality agreement is in place in line with the requirements Global template, which clearly defines cGMP roles and responsibilities between the company and the supplier/third Party, as well as product details and requirements
- Manage the quality aspects of the relationship in accordance with the effective Qual-ity Agreement. Perform the required periodic review and make recommendations for amendments
- Ensure that Change requests, either from the supplier or from the company, are man-aged according to the Quality Agreement and the SOPs from receipt, through to the implementation and closure
- Coordinate and ensure that Quality auditing of suppliers is carried out according to the Quality Manual - maintain an annual auditing program, participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs (corrective and preventive actions). Ensure site readiness for regulatory inspections at suppliers/third parties where appropriate
- Provide the quality presence and input to Technical meetings with the suppliers and establish good working relationships with clear communication and defined actions and goals
- Ensure that coordinated contact is maintained with other functions within the com-pany also dealing with External suppliers, e.g. Purchasing, Legal, Supply Chain, Regulatory CMC, Drug Regulatory Affairs, Group Quality Operations (GQO), etc
- Assess quality trends and drive continuous improvement for processes, product qual-ity performance, and cost reduction associated with supplier/third party management
- Ensure that the supplier/third party provides the required product review or the data as specified in the relevant Quality Agreement on an annual basis. Critically assess the performance of the product and process and provide the assessment to the report an-nually
- Implement and maintain a local PharmOps CH Quality System and Standard Operat-ing Procedures defining all processes to manage suppliers
- Facilitate the data compilation in response to Health Authority inquiries and in sup-port of regulatory submissions
- Manage Technical Customer Questions concerning the supplier/third party.
- Evaluate TSE (Transmissible Spongiform Encephalopathy) und GMO (Genetically Modified Organisms) status of consumables
- Manages the SUQUOR data base and provides user training as appropriate
- Perform and support internal and external audits
- Support inspections by Health Authorities, customers, etc.
- Initiate and implement quality improvement projects
Requirements:
- University/academy degree in chemistry, pharmacy or equivalent
- Professional experience in quality control/quality assurance and in the manufacturing of pharmaceutical drug products
- Profound knowledge in cGMPs
- Proven track record with FDA, EMEA and other Health Authorities.
- Strong understanding of risk assessment and risk management fundamentals/tools
- Technical understanding of pharmaceutical / biological processes
- Extensive auditing experience
- Knowledge of the current pharmacopoeia requirements including technical methods (USP, Ph. Eur.) as well as of the relevant official guidelines (FDA, EU, PIC/S, ICH etc.) with regard to microbiological quality control/assurance and cGMP
- Adjust the organisation in order to enable the team to carry out all team specific tasks in time
Direct, clear and prompt communication to team members, peers, superiors and customers. Ability to motivate, educate, train and develop people; ability to define and communicate clear targets. Team player and able to build up good relationship to PU/SUs, manufacturing departments, registration and authorities
Languages: Fluency in German language with strong English skills. Other languages are welcome
Place: Greater Basel
Contact: André Vögtlin / av1@mas.ch