Biosynth

Role and Responsibilities ​The Senior QA Officer will be a member of the Quality Assurance team, responsible for key areas of work aimed at providing and maintaining robust quality processes across the group. The role holder will be providing support to other departments as requested and will require a good working knowledge of QA regulations and procedures to fulfil the duties of the role. The Senior Role will require the ability to work autonomously and take ownership of complex quality matters, providing leadership in audits, regulatory compliance, and continuous improvement initiatives as well as global cross-site project work, supporting the Head of Quality Assurance. The position deputizes for the QA Manager in their absence. Strategic Quality Leadership Develop, maintain and continuously improve the site QMS in line with corporate standards and site relevant GMP, ISO 9001 and ISO 13485 requirements. Drive cross functional change control: chair QMS update working groups, assess impact of changes, and coordinate implementation across departments. Lead risk assessments (e.g., FMEA, HACCP) and monitor mitigation plans to proactively manage quality risks. Support cross site harmonization and GMP projects. Regulatory & Compliance Oversight Serve as primary liaison for customer audits and health authority inspections; prepare audit plans, host audit activities, and drive timely closure of findings Ensure all SOPs, batch records and quality documentation meet evolving GMP, ISO 9001 and ISO 13485 standards; champion continuous QMS updates to uphold site certifications. Customer & Supplier Quality Management Own escalation management for critical deviations and customer complaints; set thresholds, negotiate Quality Agreements with key suppliers, and monitor corrective actions. Mentoring & Training Design and deliver advanced QA training programs; coach junior staff and oversee competency assessments to build a quality focused team ethos. Questionnaires and product documentation Ensure customer questionnaires are completed within customer deadline or 2 weeks of request Ensure all questionnaires that need to be sent to a supplier are neutralised and sent within 24 hours Send neutralised questionnaires to POP to send to the supplier if the information is not on the server. If they don’t respond in 3 days chase them Save completed returned questionnaires the same day as received and ensure any customer questionnaires are saved correctly same day as they are completed Ensure the questionnaire databases (Sigma and General) are kept up to date Customer/colleague queries Reply to customer or colleague queries regarding requests for certificates or product quality information Respond to customer or colleague queries regarding requests for certificates of origin; manufacturer and retest dates; BSE/TSE statements; other statements (e.g. non-GMO, allergen), quality traces (PDP products) within 3 days Customer complaints, NCPs and deviations Investigate customer complaints Reply to the customer within an hour of receipt to assure them that their query is being investigated Investigate query within 24 hours by checking records/speaking to staff involved as necessary Log issues into the appropriate system within 24 hours of receipt Add any CAPAs and monitor progress on these Internal audits Ensure Internal Audits are carried out as per the Internal Audit Schedule Record findings and feedback to the auditee and Process owner Report any unsatisfactory results to the QA Manager 1 working day Follow up on any failed audits or observations made during the next audit month (i.e. every 3 months) Document Management Manage the controlled documents, ensuring new documents are allocated a document number in accordance with the defined system Ensure document reviews are carried out in a timely manner Manage the training records for SOPs

Role and Responsibilities Carrying out organic synthesis ranging from route finding on laboratory scale up to multi-kilogram production in 2 to 60 L reactors in the kilo-lab. Optimization of chemical reactions under guidence - including workup and product isolation - with regards to scalability. Monitoring reaction conversion and performing compound analysis using TLC, LC/MS, NMR. Purification of products via crystallization, distillation, (automated) column chromatography or prep-HPLC. Superuser of dedicated equipment or technology, including maintenance, contact with suppliers and instruction of other group members. Planning of daily practical work in discussion with the responsible Scientist. Performing general lab duties and maintaining a high standard of order and cleanliness. Accurate, detailed and regular documentation of experimental work using electronic lab journal. Supervising an apprentice, trainee or junior team members

Deine Aufgabengebiete und Verantwortungen Sicherstellen, dass die Verfahren für die Finanzaufzeichnung, Berichterstattung und -Prognose vorhanden sind und für die Organisation effektiv funktionieren Verantwortung und Mitarbeit Monats- / Quartals- und Jahresabschluss Cash Management Verantwortung MWST Einreichung CH inklusive Audit Zuständig für Anlagenbuchhaltung und Finanzierungsleasing Ansprechperson in Rechnungslegungs- und Steuerfragen für Banken, Versicherungen, Behörden und Wirtschaftsprüfer Betreuung und Beratung der Mitarbeiter am Standort Staad Support des Head of FR&A bei der Erstellung der konsolidierten Jahres-, Quartals- und Monatsabschlüssen der Biosynth Gruppe (nach UK und Swiss Gaap) und bei der Überwachung der Finanzaudit Support kontinuierlicher Verbesserungsprozesse im Finanzbereich Unterstützung des Head of FR&A mit Schwerpunkt auf Rechnungslegungsgrundsätzen, Steuern und Cash Management