Quality Assurance Officer (m/w/d)

The Biosynth Group is an innovative life science reagents, contract synthesis and manufacturing services company headquartered in Staad, Switzerland. We work as scientists for scientists and secure supply chains with consistent quality around the world. As a reliable supplier, manufacturer and partner to the pharmaceutical, life science and diagnostics industries as well as the food, agrochemical and cosmetics industries, we have facilities on three continents and a fast global distribution network. Our main production laboratories are located in Switzerland, the UK, Slovakia and China, peptide and antibody production in the USA and the Netherlands. Enzyme projects are located in Austria and biological IVD reagents in Ireland.

At the Berlin site, Biosynth GmbH carries out contract development and production in the field of bioconjugation and polymer-based drug delivery. Biosynth GmbH has a manufacturing license according to Section 13 AMG for the production of bioconjugated active ingredients and conjugate vaccines.

Purpose of the Role

The position holder will be a member of the quality assurance team and will be responsible for executing and maintaining quality processes at the Berlin location.

Key Responsibilities

General

• The position holder will be a member of the quality assurance team and will be responsible for executing and maintaining quality processes at the Berlin location.
• The role holder will provide support to other departments as requested and will require a good working knowledge of QA regulations and procedures to fulfill the duties of the role.

Document Management

• Creation and review of controlled documents.
• Support in the transition from a paper-based to an electronic DMS.
• Operation of the eDMS including training module.
• Assumption of the task of the archive manager.

Audits and Inspections

• Participation in audits/inspections by customers or authorities.
• Participation in GMP audits at suppliers.
• Tracking actions from audit observations.

Internal Audits

• Conducting internal audits, preparing audit reports with determination of appropriate corrective and preventive measures.
• Record results and provide feedback to the auditee and process owner.
• Reporting key observations to the QA manager within one working day.
• Tracking actions from audit observations.

Complaints, Changes and Deviations

• Initial investigation of the task within 24 hours, review of records/consultation with the employees involved if necessary.
• Notification of tasks within 24 hours of receipt in the appropriate system.
• Initiation of CAPAs and monitoring of progress.
• Compliance with occupational safety regulations.
• Team player.
• Respond to Teams, email, and phone messages in a timely and respectful manner.
• Training other team members and colleagues, identifying training needs.
• Understanding/experience of quality processes and procedures.
• Proven organizational skills with the ability to prioritize one’s workload.
• Experience in effective and cooperative team collaboration.
• Fluent in written and spoken English and German.
• Able to work independently and seek advice if necessary.
• Strong IT skills, including word processing, spreadsheets, databases, and use of email and the Internet.
• Great attention to detail.
• A degree in a relevant scientific subject.
• Experience in a pharma company or a CDMO.
• Experience of working in a GMP environment.
• Knowledge of an eDMS.
• Knowledge of SAP.

We Offer

• A dynamic working environment and diverse tasks.
• An organizational structure that promotes open communication and offers a cooperative working environment.
• Continuous participation in internal and external training courses.
• Subsidy for canteen meals.
• Company health management with access to a fitness room and sports courses.
• Good transport links by public transport.

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