Quality Engineering Specialist (5840)
Quality Engineering Specialist – 5840 ADA
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for aQuality Engineering Specialist (QA Qualification Specialist) based in Stein, Switzerland for a 6-month contract with possible extension.
IMP: The selected candidate will be responsible for Commissioning & Qualification (C&Q) compliance of an aseptic fill-finish drug product manufacturing facility CAPEX project. Main focus will be on QA Compliance and Operational readiness of the fill finish aseptic line before the Swissmedic inspection.
Main Responsibilities:
· Responsible for the quality oversight and regulatory aspects of the assigned CAPEX project
· Ensuring C&Q compliance of GMP systems related to the aseptic fill-finish facility (equipment/utilities/facilities) during the project management lifecycle from design engineering through to the initial C&Q and handover phases
· Reviewing and approving C&Q documents of GMP systems as well as related changes and deviations
· Supporting audits and regulatory inspections (Swissmedic, FDA, etc.)
· Providing leadership and guidance to project team members on C&Q strategy and issues
· Ensuring that decisions are fully supported by global and local Quality, as well as Regulatory
· Escalating issues in an open and timely manner and take leadership for their resolution
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required.
- Bachelor or Master's degree in Engineering, Life Sciences or related field
- Significant experience in the GMP regulated pharmaceutical industry, preferably in a role within a Quality Unit
- Experience in a QA role for the C&Q of GMP systems related to aseptic fill-finish processes and facility (filling equipment, lyophilization, clean utilities, and clean room facilities)
- Fluent in English, German would be an advantage