Soft Skills Coaching

Qualification and Validation - IT

GMP Compliance

• Complex Q&V Project Management

• Q&V Procedures

• Q&V Master Plans

• User Requirement Specifications

• Risk analyses

• Traceability matrices

• Q&V Plans and reports (DQ, IQ, OQ and PQ)

• Deviation reports and action plans

• Q&V Master Reports

• Requalification and Revalidation procedures

• Cleaning Validation

• Process Validation

• IT Computer System Validation

• Cleanrooms

• HVAC systems

• Process equipment

• Temperature and humidity controlled areas

• Utilities

• Process Monitoring

• Maintenance Procedures

• Evaluation of Quality Systems

• Elaboration or revision of SOP’s or other quality documents

• Handling of deviations

• Handling of Change Controls

• Elaboration and follow up of preventive and corrective action plans

• Elaboration of an yearly audit plan

• Supplier audits

• Internal audits

• Preparation of audits from the international authorities

• QP services

• GxP-compliance evaluation of existing plants and installations

• Managing Time and Resource

• Effectively working with Outlook

• Effectively communicating

• Effectively working as a team member

• Effectively working as a team leader

• Working Life Balance

• Speaking German

• Speaking French

• Speaking English

• Effectively presenting

What We Offer

Discover MASY Group GmbH's unparalleled expertise, where our dedicated team ensures the integrity and performance of IT systems through qualification and validation, navigates the complexities of GMP standards and fosters personal development through soft skills coaching. Our experts bring deep industry and functional knowledge, challenging the status quo and sparking transformative change. Operating in a uniquely collaborative model, we engage with clients at all levels, driven by the shared goal of propelling their success and contributing to a better world.

MASY Group GmbH Expertise Spectrum

To keep our excellence, focusing on a select number of distinguished projects each year is our hallmark. Guided by an unwavering commitment to the highest standards, every endeavour is led by a dedicated senior expert meticulously chosen to serve as your exclusive point of contact throughout the entire project life cycle. This deliberate approach ensures not only the success of your project but also elevates your experience to an extraordinary standard of satisfaction.

Book Us Now