Documentation Specialist (m/w/d)

Lee Hecht Harrison Nederland B.V.; Luzern; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Lee Hecht Harrison Nederland B.V. seeks a Documentation Specialist to manage GMP documentation for Metrology & Validation and Compliance teams. The role offers growth potential and requires strong technical documentation skills and cross-team collaboration.

Ideal candidates have a biotech/pharma QA background, with English (and German) communication skills, and the ability to drive digital documentation processes in a dynamic manufacturing environment.

Qualifikationen

• Education options include a Biotech/Pharma/QA focus or related university degree.
• Strong communication in English (B1) and German (B2) is preferred.
• Experience with technical documentation and ALCOA+ principles is valued.

Aufgaben

• Manage documentation storage and archival for Metrology & Validation and Compliance.
• Develop a digital documentation management process for quick access.
• Archive documentation per record retention policies.
• Coordinate with cross-functional teams to ensure compliance.

Kenntnisse

Communication

Documentation

Problem solving

Coordination

Teamwork

Ausbildung

Technical Apprenticeship in Biotech/Pharma/QA

University degree in Biotech/Pharma/QA

Jobbeschreibung

We are currently seeking a detail-oriented Documentation Specialist (m/w/d) to join our client’s Manufacturing Operations team in a dynamic, fast-paced biopharmaceutical environment.

The candidate will work at the local site and in alignment with our global Metrology & Validation and Compliance teams. The position offers development potential, and responsibilities can be adjusted to the candidate’s qualifications and ambitions.

The Metrology & Validation team have oversight of all laboratory instrumentation and equipment, providing daily hands-on support, oversight of scheduled maintenance/calibrations and the qualification of new analytical instrumentation and Computer Systems projects within a GMP environment. Responsibility of this function is to maintain the analytical laboratory instruments and implement new systems in a state of permanent inspection readiness.

The Compliance team has oversight of all employee training and compliance related documentation for the organization. Their role within the organization is key to maintaining regulatory complianceand ensure accessibility of the documents in accordance with ALCOA+ principles.

Key Responsibilities

• Provide day-to-day support to the Metrology & Validation and Compliance team by managing the documentation storage and archival.
• Developing a digital documentation management process to ensure quick and reliable accessibility to documentation at a moment’s notice.
• Archiving documentation in alignment with company’s record retention requirements.
• Support site-wide projects and initiatives directly related to Metrology & Validation, Compliance, and/or PADT

Required Qualifications

• Education – candidate could have one of the following:
• Technical education (Apprenticeship) in Biotech, Pharmaceutical industry, Quality Assurance, Regulatory Compliance or related areas
• University degree in Biotech, Pharmaceutical industry, Quality Assurance, Regulatory Compliance or related areas

Preferred Qualifications

• Strong oral and written communication skills in English (B1) and German (B2)
• Strong documentation skills on technical documents, attention to detail
• Demonstrated ability for taking initiative and innovative problem solving in collaboration with other team members
• Daily communication and coordination with multiple team’s in support of maintaining documentation onsite.
• Ability to work independently and within a cross-functional team to deliver on timelines in a dynamic environment

Advantage:

• Experience with project management methodologies, software, or tools
• Experience in GMP environment, especially in GMP laboratories
• Experience in Auditing and Compliance within the pharmaceutical industry
• Thorough understanding of GMP policies and procedures and proven experience working with Quality

Day in the job:

• Manage the consistent flow of documentation as a result of day-to-day metrology & validation and compliance business (e.g., Preventative Maintenance and Operational Qualificaiton Documentation, training files)
• Built or reconfigure a digital documentation management system establish an easy to navigate solution to query documentation.
• Archive/store documentation within the documentation management system
• Ensure documentation is being archived according to the company’s record retention policies.
• Coordination with cross-functional teams and quality to ensure compliance on the documentation management process.
• Typical start time between 7:00 and 8:45 am

Additional information:

• Contract duration: This is a 12-month contract position, planned to start 13.10.2026 till 12.04.2027.
• Type of employment: Temporary staffing
• Location: Schachen
• Working type: onsite

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