GMP Documentation Specialist (Metrology & Compliance)

Randstad Switzerland; Luzern; Hybrid; CHF 65.000 - 90.000; Vollzeit

Zusammenfassung

Randstad Switzerland is seeking a Documentation Specialist for a Swiss site in the pharmaceutical sector. The role focuses on developing and maintaining a digital documentation management process for Training and Instrument related service documentation within a GMP environment.

You will work with Metrology & Validation and Compliance teams to ensure documentation is accessible, compliant, and archived according to retention policies, with on-site emphasis and limited home-office on request.

Qualifikationen

• Apprenticeship or degree in Biotech, Pharma, QA or Regulatory Compliance or related areas
• Strong documentation skills on technical documents, attention to detail
• Ability to work independently and in cross-functional teams

Aufgaben

• Provide day-to-day support to Metrology & Validation and Compliance teams by managing documentation storage and archival
• Develop a digital documentation management process for quick and reliable access to documents
• Archive documentation in line with record retention requirements
• Support site-wide projects related to Metrology, Validation, Compliance, and PADT
• Coordinate with cross-functional teams to ensure compliance of documentation

Kenntnisse

English B1

German B2

Documentation skills

Ausbildung

Biotech/Pharma apprenticeship or university degree

Jobbeschreibung

For one of our clients, an international pharmaceutical company, we are seeking a Documentation Specialist.

General Information:

• End Date: 12.04.2027
• Working hours: Standard
• Home Office: primarily onsite, home office is available on a need basis

About the work:

Our client’s Pharmaceutical Analysis & Digital Technologies (PADT) department located in Schachen in Switzerland, is currently offering an attractive position for an individual with a background or interest in developing a digital documentation management process for Training & Instrument related service documentation in a GMP regulated environment. In this position you will work at the local site and in alignment with the global Metrology & Validation and Compliance teams.

The Metrology & Validation team oversees 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 compliance and ensuring accessibility of the documents in accordance with ALCOA+ principles. As a result, developing and maintaining a robust documentation management process is integral to ensuring compliance and maintaining accessibility to documentation.

Tasks & 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

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 Qualification Documentation, training files)
• Build or reconfigure a digital documentation management system establishes 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

Requirements:

• Technical education (Apprenticeship) in Biotech, Pharmaceutical industry, Quality Assurance, Regulatory Compliance or related areas or University degree in Biotech, Pharmaceutical industry, Quality Assurance, Regulatory Compliance or related areas
• 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

Nice to haves:

• 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