Biotech & Aseptic Process Quality & Compliance

vor 1 Monat

SaintPrex, Schweiz Ferring Pharmaceuticals, Inc. Vollzeit

Job Description:
Are you looking for a challenging and impactful position in Global Quality Management in Biotech and Aseptic operations?

If yes, this new position may be the right one for you.

Role:
In this position, you will support and ensure that Ferring Biotech and Aseptic manufacturing processes, product intermediates, products and quality systems comply to Ferring quality standards, Local Regulatory requirements and International GMP Standards.

As the Biotech & Aseptic Process Quality and Compliance SME, your overall focus is ensuring the continuous delivery of products meetings the needs of our patients and in compliance with both regulatory and technical requirements. You will encourage the use of modern risk-based approach and support continuous improvement and innovation initiatives aiming to strengthen the quality of the products delivered to our patients.

You will be the Global Quality Assurance point of contact for the manufacturing sites and you will liaise with the local QAs and technical experts in the respective manufacturing sites to ensure successful quality operations.

Your primary tasks will be to:
- Collaborate with Ferring Biotech and Aseptic manufacturing sites to maintain and improve existing quality processes and systems (Change Control, CAPA, Deviations, Complaints, internal GxP audits, Regulatory Inspections, etc) this is to ensure continuously compliant operation of quality processes- Support Ferring Biotech and Aseptic manufacturing sites in process and analytical methods troubleshooting, root cause investigations when significant quality issues are identified- Support Ferring Biotech and Aseptic manufacturing sites in the development of appropriate corrective and preventive action plans and implementation within a reasonable timescale to eliminate the root cause of a non-conformance- Support the manufacturing sites in the identification and assessment of quality risks and in the elaboration of mitigation actions to reduce/eliminate identified quality risks- Support and drive the implementation of continuous improvement, efficiency, and state of the art technologies across Ferring manufacturing sites- Work closely with the development team to engineer solutions to address defects and provide feedback or recommendations on strategy implementation- Support technology and analytical methods transfers within Ferring manufacturing sites and from/to external manufacturing partners- Work closely with manufacturing sites and Global Manufacturing Technical Team to facilitate harmonization and improvement of manufacturing processes in alignment with regulatory files and GMP requirements

Qualifications:
- Master’s degree or PhD in a scientific or related discipline- At least 7 years work experience in the biotech and aseptic manufacturing, quality assurance and/or quality control with both local and international working experience- Strong knowledge and experience of the pharmaceutical regulations and regulatory environment (EU, FDA, JP, CN and others)- Fluent in English (written and verbal communication)- Excellent interpersonal and communication skills- Strong business mind-set with demonstrated ability of conceptual and strategic thinking- Good project management skills

You will join the Global Quality Assurance team based in St. Prex, Switzerland and you will report to the Head of Biotech and Aseptic Manufacturing Quality.

The working atmosphere is characterized by respect and a shared passion for improving life of our patients.

Ferring + you: Why join Ferring?

Our philosophy of ‘people come first’ flows through every part of the business. Our future is shaped by a science-driven approach and a passion to lead as well as our need to collaborate and develop long-lasting relationships to ensure that our focus remains on innovation.

**Location**:
Switzerland HQ - St-Prex

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