QA Specialist DP Operations (Fill & Finish) (M/F)

QA Specialist DP Operations (Fill & Finish) (M/F)

Start: ASAP
Temporary 16 months
Canton of Vaud

Join the Quality Assurance (QA) team of a major biopharmaceutical player in Northern Vaud.

As a QA Fill & Finish Specialist, you ensure Quality oversight of monoclonal antibody filling and finishing operations, including aseptic filling, associated manufacturing activities, and manual visual inspection. You work on QA deliverables related to GMP operational readiness, routine aseptic manufacturing, compliance, Right-First-Time execution, and continuous improvement, in accordance with cGMP regulations and Annex 1 of the European GMP (EudraLex).

Your main responsibilities

Project Phase - Design, Qualification & Commissioning

• Contribute to QA assessments of Change Controls (GMP impact, traceability, and documentation).

• Support quality risk management (QRM) and ensure its integration into manufacturing/engineering documentation and operational controls.

• Review and contribute to the development of GMP documentation for new Fill & Finish processes/equipment (SOPs, protocols, forms, registers, batch record templates).

• Support the integration of Annex 1 requirements (contamination control, sterility assurance, aseptic process simulation).

• Participate in project meetings and cross-functional workshops to ensure alignment with the site’s Quality requirements.

• Promote a Right-First-Time mindset by proactively identifying risks and compliance deviations.

Operational Phase - Aseptic Manufacturing Operations

• Ensure daily QA on-the-floor oversight of classified areas (aseptic filling, component preparation, visual inspection, washing, sterilisation, and packaging interfaces).

• Work closely with production to prevent issues and promptly address unforeseen events.

• Perform batch record reviews within defined timelines and support batch release.

• Ensure compliance in material management during production (traceability, identification).

• Review and approve GMP documentation (SOPs, master batch records, registers) and ensure adherence to procedures.

• Conduct GMP visits (GEMBA walks) and monitor the implementation of actions arising from these visits.

Deviations, CAPA & Improvement

• Review and approve manufacturing deviations and investigations; escalate major or critical issues.

• Recommend and approve CAPA plans, then ensure their implementation within deadlines.

• Review, evaluate, and approve changes (Change Control) within your scope.

• Contribute to risk assessments and participate in continuous improvement initiatives.

QA Representation & Compliance

• Represent QA at daily operational meetings and interact with internal teams.

• Support inspection readiness and represent QA for the manufacturing sector during health authority inspections.

• Promote the application and understanding of cGMPs, especially Annex 1 (aseptic practices, cleanroom behaviour, environmental monitoring).

Your profile

• Education & Experience: University degree in natural or applied sciences (Pharmacy, Chemistry, Biotechnology, Engineering). At least 3 years of experience in Operational Quality Assurance at an aseptic pharmaceutical manufacturing site.

• Technical skills:

  • Strong knowledge of cGMP and international regulatory requirements.

  • Mastery/willingness to provide strong expertise on EudraLex Annex 1 principles and sterility assurance; knowledge of isolator technology is an asset.

  • Experience interacting with health authorities during inspections (an asset).

• Soft Skills: Strong analytical and problem-solving skills, structured and fluent communication, collaborative spirit.

• Languages: Fluent French (written and spoken) and ideally a good level of English.