QA Specialist Supplier Qualification
Posted on Jan 11, 2020 by Harvey Nash IT Recruitment Switzerland
For our client in Stein we are looking for QA Specialist Supplier Qualification/Senior QA Professional Supplier Qualification for 11-month contract.
Job title: QA Specialist Supplier Qualification/Senior QA Professional Supplier Qualification
Duration: ASAP - 31.12.2020
Work location: Stein
Support the qualification and management of NTO Stein CGT external suppliers, contract manufacturers and service providers and performs equipment qualification. Ensure that the supplier/contract manufacturer operates in compliance with cGMP and regulatory requirements, the Quality Agreement, the Pharma Quality Manual and relevant SOPs. In addition, ensures that equipment qualification complies with cGMP, legal and regulatory requirements as well as the Pharma Corporate Quality Manual and Policies. This role requires adherence to specific cGMP requirements and execution according to the valid SOP's.
. Support qualification of suppliers, contract manufacturers and service providers and ensure that all tasks performed are in compliance with Company Quality Manual, the effective Quality Agreement and that they meet relevant cGMP regulatory requirements and are conducted according to local SOPs
. Drive and initiate Supplier Quality Risk assessments
. Evaluate the need and support the implementation of Quality agreement in line with Global templates, global Quality Directives and local SOPs, which clearly defines cGMP roles and responsibilities between 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 QualityAgreement. Perform the required periodic review and make recommendations for amendments
. Initiate Change requests and AQWA Quality Events (supplier or service provider related) and ensure that they are managed according to the Quality Agreement and Sompany SOPs
. Establish good working relationships with suppliers and service providers with clear communication and defined actions and goals
. Ensure that coordinated contact is maintained with other functions within the company also dealing with External suppliers, eg Purchasing, Legal, Supply Chain, Regulatory CMC, Drug Regulatory Affairs, Group Quality Operations (GQO), etc.
. A university or academic degree in Engineering, Chemistry, Pharmacy, Biology or equivalent.
. Professional in German and English (spoken and written).
. Experience in regulations (including medical devices), very good GMP knowledge, experience in the pharmaceutical industry, QA/QC or comparable experience in other industries.
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