This role is based in Germany therefore there is a need for strong English and German language proficiency in a business context.
Core Responsibilities
Achieving the objectives and procedures of Computer Systems Validation (CSV) specifically 21 CFR part 11 and EU Annex 11.
Consulting and input to guide and shape validation strategy for hybrid cloud solutions using your knowledge of cGMP, GxP, GLP, GDP, and industry health and safety regulations
Requirements analysis, definition, and implementation of software validation projects.
Create validation roadmaps and relevant validation project program artefacts to manage stakeholders and support the achievement of the clients' quality and compliance objectives.
Develop and write validation master plans and validation procedures (SOPs) according to regulatory requirements.
Generation and execution of validation protocols and reports (including URS, IQ, OQ, PQ, QAP, etc.).
Performing qualification and validation of computerised systems, equipment, facilities, services, and processes in line with client procedures and industry standards.
Develop and execute Commissioning & Qualification lifecycle protocols per the specific project requirements.
Supporting Quality Management processes, Periodic Review of GxP Systems, Change Control, Incident / Problem Management, CAPA.
Ensure audit readiness and provide pre-audit preparation and support
Nurture long-term relationships and partner with the customer's validation and quality assurance teams, other internal teams, vendors, partners and third parties.
Guidance and oversight for validation teams; acting as the voice of the customer and mentor for other validation team members as part of a global team in an international environment.
Ability to work effectively in a regulated and/or ISO-compliant environment.
In an ideal world, you will have the following skills:
Awareness of ITIL, SDLC processes and/or Computer System Validation methods, such as GAMP5.
Strong collaboration skills with the ability to manage several tasks simultaneously and a self-starting, proactive and flexible approach.
An analytical thinker with a structured problem-solving and flexible approach.
Proven experience validating solutions On-Prem or in the Cloud.
Experience with method validation in GxP environments (e.g. Analytical, Bioanalytical, process, equipment, and cleaning).
Strong understanding of established and evolving industry standards and best practices driving computer systems validation.
Nice to have:
Experience with Scientific Informatics solutions
A Background in biochemistry, bioinformatics, pharmacy or chemistry with relevant practical experience and familiarity with laboratory processes, Scientific Informatics or Manufacturing.
Experience in Life Sciences Industry.
Experience supporting pre-audit, audit, audit findings and remediation planning.
Proven experience with project delivery processes and methodologies - Waterfall, Agile, Safe, CI/CD, DevOps, ITIL and associated tools
In addition to the technical skills, you will also bring the following…:
Curiosity to learn and a passion to enable digital evolution.
A passion for ensuring customers have an amazing experience when they interact with you.
Able to relay, complex information in simple terms to internal, partner and customer stakeholders with different levels of technical knowledge.
Confident and effective in communicating across teams, management tiers and with customers both in writing and verbally.
Flexibility for some onsite working
