Posição: Entry level

Tipo de empregos: Full-time

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Conteúdo do emprego

Are you a Quality Engineer interested in working for one of the most interesting names in High-Tech Biopharmaceuticals?

Are you looking for something new?!

Title: Quality Engineer

Location: Lugano, Switzerland

Rate: Open

Openings: 1 Engineer

Contract/Perm: Contract (12-Months)

A Fantastic new role has just opened up at one of our leading Swiss based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.

Responsibilities
  • Supports the Product Release Monitoring and Strategic Collaborator Employee Certification Program.
  • Reviews and approves key quality records as they related to JJMD products in accordance to the Quality Agreement, such as:
  • Nonconformance records (incl. CAPA’s and Product Dispositions),
  • Site Validation Master Plan and Validation protocols,
  • Inspection plans and associated sampling strategies,
  • Where necessary, collaborate in failure investigation and corrective action planning involving JJMD products.
  • Coordinates JJMD review of nonconformance disposition in collaboration with other required JJMD functions (such as Franchise Quality, Regulatory Affairs, etc.)
  • Supports Strategic Collaborators Quality and Manufacturing Engineering on the resolution of quality issues impacting JJMD products and coordinates additional subject matter expert support needed from JJMD.
  • Initiates Stop Shipments and Product Issue Escalations for products out of JJMD control.
  • Supports improvement plans to address below-target metrics and negative trends.
  • Partners with SC on Recall Prevention and External Audit Readiness initiatives.
  • Serves as the Source Quality Manager deputy.
Requirements
  • A minimum of a bachelor’s degree, preferably in Engineering or related technical field. 4/ 6 years related experience preferred.
  • Experience working in both an FDA and European regulatory environment is preferred.
  • This position will require relevant background in manufacturing/operations.
  • Experience with a consistent track record of implementing appropriate risk mitigation.
  • Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
  • Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision-making.
  • Ability to perform "hands on" troubleshooting and problem solving.
  • Good technical understanding of manufacturing equipment and processes is required.
  • Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
  • A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
  • Quality Engineering Certifications are a plus (e.g. ASQ CQE, PMI PMP, 6-Sigma, etc.).
  • Business Fluent English and Italian required
If you are interested, please do not hesitate to email or call me!

S.Hubert@Proclinical.com

DL: +44 203 949 8594

CH: +41 61 508 7073

Mob: +44 7592 053 700
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Data limite: 08-04-2024

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