24 days ago on krb-sjobs.brassring.com

QA Operation Specialist

Ferring Pharmaceuticals SA

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QA Operation Specialist

Job ID 369BR Job Title QA Operation Specialist Division Central Functions Department Quality Assurance Group Local Quality Assurance Country Switzerland Location Saint-Prex About Us Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. Role - Ensure that batch records are reviewed in a timely manner according to all SOPs, carry out Quality reports investigations and closure, in order batches could be released by QP, or tis delegate, in conformity with the registration dossier and cGMPs. Main Responsibilities - Ensure GMP compliance for production activities

- Production batch review in order to assess the quality of the batch

- change status of component if appropriate to ensure GMP rules. Reject boxes and batches when appropriate.

- Manage, evaluate deviations on batch product, and drive investigations plan and corrective action. Decide about batches affected by deviation when appropriate

- Ensure GMP compliance especially during reprocessing activities. Approve protocol prior execution

- Follow up CAPA and change control for production activities

- Ensure feasibility of current SOP for QA operation activities and update as appropriate timeline

- Ensure validity of equipment used for production activities based on qualification status defined

- Approve master batch records, master data and packaging instructions 

- Support health inspection and customer audits 

 
Required Experience & Skills - University Degree and Scientific background

- Minimum 3-5 years experience in pharmaceuticals industry

- Good experience in QA release department

- Strong understanding of cGMPs

- Good knowledge in Regulatory requirements

- Good communication and interpersonal skill

- Fluency in English

- Team spirit, flexible, result-oriented

- Decision quality

- availability immediately
Contract Type Temporary Contract Duration (Months) 6 Role Type Full Time