Quality Specialist (m/f/d)

REFERENCE NUMBER:

714090/1

MY DUTIES:

- Provide QA oversight support for External Manufacturer, based in Switzerland
- Contribute to the ongoing technology transfers, inspection readiness, implementation, and execution of quality systems in support of the external manufacture of pharma large molecules (Fill-Finish activities)
- Support the External Quality account owner on tech transfers/projects as appropriate
- Requires solid knowledge in all quality systems concerning the manufacture of drug products and extensive knowledge of QA, QC and Compliance
- Requires travel to the External Manufacturer site to provide cGMP assistance and quality oversight
- Serve as a contact point within the QA organization of other departments of both the company and the external manufacturer with respect to quality relevant subjects
- Build relationships and influence external partners to continuously enhance quality culture and business excellence
- Perform review of equipment and facility qualification, environmental monitoring, technical documents, raw material specifications, analytical methods, and master batch records to ensure cGMP requirements
- Provide QA support for technology transfer and improvement of existing manufacturing processes
- Following successful tech transfer, support day-to-day quality oversight for production activities, including identification of risks, deviation and CAPA management, Complaint handling, change control, and batch documentation review
- Ensure that all relevant QA related concerns at the external manufacturer’s sites are raised to the External Quality Account Owner
- Ensure the timely supply of Product Quality Reports (PQRs) from the external manufacturer according to schedule. Carry out a documented review of PQRs
- Apply applicable GMP regulations international requirements to all aspects of the position
- Support regulatory inspection readiness at the external manufacturer for the products
- Monitor trends, identify issues, recommend, and implement appropriate actions

MY QUALIFICATIONS:

- Bachelor’s Degree with a concentration in engineering, science, or an equivalent technical discipline
- Solid knowledge of GMP, specifically: Aseptic manufacture (sterile, liquid dosage forms products and/or Large Molecule) experience is preferred (QA and/or production)
- Able to connect easily, team worker, able to manage across cultures
- Able to work independently while managing stakeholders, to handle complexity, and to take ownership for deliverables, as well as flexibility and confirmed collaboration skills, are required
- Able to think outside the box and come up with solutions to problems. Open-minded for new ideas and willing to pivot when necessary
- Strong interpersonal and written/oral communication skills
- Advanced degrees are a plus and may reduce the experience required
- Proficiency in English is a must
- Located in Switzerland (In or nearby Canton of Valais)
- Will require travel to the external Manufacturer

MY BENEFITS:

- International reputed Pharmaceutical organisation
- Hybrid working model with 2-3 days on site
- Committed, innovative, friendly... team
- High degree of personal responsibility

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.