Quality SGIE Specialist

Posted 16 August 2023
Job type Contract
Contact NameEmma Presley

Job description

Title: Quality Assurance Manager
Location: Switzerland
Hourly Rate: Competitive
Employment Type: Contract
Industry: Pharmaceutical

BioTalent is delighted to be partnered with a leading Pharmaceutical Manufacturing based in Switzerland and we are on the hunt for an experienced Quality Assurance Manager who will be responsible for the Commissioning & Qualification compliance of an aseptic fill-finish drug product manufacturing facility CAPEX project.

Key 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

Key Requirements:

• 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