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:
o Nonconformance records (incl. CAPA's and Product Dispositions),
o Site Validation Master Plan and Validation protocols,
o Inspection plans and associated sampling strategies,
o 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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