Investigations Lead

Position overview

The Non-conformance Investigator position in MSIT aims to follow the overall process of non-conformance investigations, based on Johnson & Johnson requirements. The investigator will be responsible for the E2E investigation process: initiation, lead and writing of impact assessment, leading execution of the investigation of Medium/High Impact Non-conformances, aiming at the identification of assignable and/or root cause, as well as implementation of corrections, Corrective and/or Preventive Actions to prevent Recurrence, and effectiveness check.

Main Responsibilities:

• Independently lead non-conformance issuance, performance of impact assessment and respective investigation to prevent recurrences in support of Manufacturing operations.

• Gathering Data from various sources across the site, performance of Root Cause Analysis (RCA) to determine the most likely cause of the non-conformance investigation, identification of Corrections and Corrective and Preventative Actions to reduce or prevent recurrence.

• Routine interaction with the Operations, Quality Control, Quality, Assurance, and other departments to communicate investigational status, perform alignment meetings, facilitate reviews, CAPA discussions and comments resolution.

• Technical writing of investigation reports for the educated but uninformed reader, that accurately capture immediate actions and containment of the event, conclusion on the cause of the non-conformance and follow-up actions to prevent recurrence.

• Work on the manufacturing floor together with other SMEs for data gathering, observing processes for investigations, and performance of associated interviews (e. g. operators).

• Meeting Facilitation and participation, aligning both internal and quality review team and the area subject matter experts on an agreed investigational path forward.

• Management of multiple quality investigation projects and timelines concurrently. Ability to adhere to standard timelines and escalate actions appropriately for resolution in a timely manner.

• Work as an SME in the corresponding team on assigned tasks and processes other than the assigned investigational lead.

• Input on validation and qualification assessments

• Present in investigations during audits/health authorities’ inspections

Who we are looking for:

• Bachelor or advanced degree in Chemistry, Biochemistry, Pharmacy, or relevant scientific discipline or equivalent combination of education, training and experience.

• 3+ years background in biopharma production environment regulated by cGMP standards, preferably in manufacturing operations and/or Quality Control.

• Skilled in supporting pharma process investigations, experienced in Root Cause Analysis tools (e.g. 5 Why, Fishbone, Kepner-Tregoe) and technical writing.

• Analytical thinking and problem-solving attitude combined with good teamwork capabilities

• Good complex conflict resolution, problem solving in a cross functional setting. Ideally certified “Green” or “Black” belt lean-six sigma.

• Experience in project lead

• Excel in a quality driven organization

• Can prioritize multiple assignments and changing priorities.

• Language Requirements: Proficiency in English is required. German language skills are desirable but not mandatory

This job based in Bern, Switzerland will initially be limited to approx. 12 months. If you are interested in working with a global leading pharmaceutical company in a dynamic, progressive, and collaborative environment, then send us your application today. Or give us a call if you have any questions!