Quality Engineers, Validation Consultant

Highly Competitive
  1. Contract
  2. Good Pharmacovigilance Practice (GVP)
  3. Switzerland
Posting date: 30 Jan 2019

A new job opportunity has arisen for an exciting Quality Engineer, Validation Consultant position to join an internationally known pharmaceutical organisation. ProClinical is advertising this position for an enthusiastic and hard-working individual to join this exciting company's office based in Switzerland. This is a contracted position.

The Quality Engineer, Validation Consultant will focus on integrating Vendors currently controlled within the QMS of an acquired company, onto the company's ASL. This position's incumbent will ensure that current supplier controls within the acquired company's QMS are maintained, whilst working with the Vendors to document and improve process controls to ensure seamless integration.

The incumbent will provide Quality Leadership for the control of multiple vendors supporting the manufacture of acquired medical devices, including Instrumentation, Sterilisation, Sterile Packaging, Acid Etch and Laser Marking. Ownership will include Supplier Quality relationships with each vendor.

Job Responsibilities:

  • Providing Quality point of contact with select Vendors.
  • Working at select Vendor locations to remediate quality documentation, conduct process, capability studies, managing the vendor in the creation/execution of validation studies as required, developing supplier proficiency in risk assessment (such as PFMEA) managing training and certification of operators and inspectors to CTQs with suppliers as required, developing and implementing efficient inspection points, and controlling plans at the supplier that will eliminate further inspection at the company site.
  • Conducting on-site quality and process assessments at Vendors to approve new suppliers and assessing established suppliers.
  • Designing and validating processes where appropriate.
  • Participating and leading in design for manufacturability evaluations where appropriate for Supplier Quality related projects.
  • Ensuring robust supplier risk management plans, based on risk categorisation, are established and executed in line with company strategy for risk identification.
  • Actively supporting the overall strategy for risk identification, mitigation, and communication.
  • Resolving problems and eliminating constraints to ensure project and supply targets are met.
  • Ensuring suppliers meet change control requirements.
  • Generating Quality metrics on supplier performances and establishing measures to monitor quality costs and cost avoidance.
  • Communicating and assuring the appropriate implementation of Quality Process Specifications (QPS) and Raw Material Specifications (RMS).
  • Ensuring effective and timely closure on all Supplier Corrective Action Requests.
  • Maintaining standards of housekeeping & GMP requirements.
  • Assisting in the development, implementation, and review of standard operating procedures Internal and External Relationships.

Skills and Requirements:

  • At least a bachelor's degree, though a Master's degree is a plus. Equivalent experience/qualifications will also be considered.
  • A minimum of five years' experience in a quality role within a regulated industry.
  • Demonstrable experience with Quality Auditing (external).
  • Knowledge of FDA, ISO, and other specific Quality System requirements specific to Medical Device Design and Manufacturing.
  • Knowledge of Additive Manufacturing (£D-Printing) processes.
  • A thorough understanding of quality systems and regulations and business impact of decisions and actions.
  • Willingness to travel.
  • Process Excellence - Green/Black belt certification.
  • Experience in SPC, Product Validation, and ISO 13485.
  • Medical device/diagnostic industry experience.
  • Proficiency in Microsoft Office Suite.
  • Excellent organisational skills; an ability to work independently and in a team.
  • Confidence, self-reliance, and quick learning skills all desirable attributes.
  • Good oral and written English communication and interpersonal skills. German or French are a plus.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Caleb Mensah on +44 203 854 1080 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.