Quality Specialist

Highly Competitive
  1. Permanent
  2. Good Distribution Practice (GDP)
  3. Switzerland
Schaffhausen, Switzerland
Posting date: 17 Mar 2021

A 12month contract opportunity has become available for a Quality specialist to be responsible for equipment and premises used for parental manufacturing across Switzerland sites. This company has an impressive pipeline of new products and would be an exceptional opportunity to join them and contribute towards its success.

Job Responsibilities

  • Provide Quality and Compliance guidance to assigned departments
  • Perform Quality and aseptic oversight on the shop floor
  • Active contribution to new concepts and projects as well as suggestions for improvement in the above-mentioned areas
  • Proactive risk mitigation
  • Assessment and approval of Quality issues/ investigations (QIs) and CPAs related to facility, environment and equipment. Investigation quality lead for major non-conformances (deviations)
  • Review and approval of Protocol, Reports, SOPs/WIs, Change requests (COCs) and further documents
  • Review and approval of GMP critical SAP master data (e. g. bill of material, manufacturing instructions etc.)
  • Support of ‚customers' (production, logistics, technical operations, engineering, etc.) in terms of GMP Compliance
  • Participation as Subject Matter Expert in Health Authority inspections and audits

Skills and Requirements

  • Bachelor or Master Degree in a microbiological, technical or science field
  • Proven experience (5 yrs) in a GMP regulated aseptic Pharma production environment or experience in a relevant quality role (3 yrs)
  • Strong technical and process background in sterile fill and finish production
  • Strong knowledge in aseptic processing preferred
  • Experience as team or project lead preferred
  • Advanced skills in English (oral and written) and min. conversational German

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceuticals