Onsite Execution
As a GMP service company, Medcycle not only offers advice and implementation of GMP requirements, but also long-term support in pharmaceutical/biotechnological quality assurance at the customer's site. Are there peak loads? A staff shortage needs to be covered at short notice? Sabbatical or parental leave replacements cannot be filled internally? By providing qualified and trained employees flexibly and immediately, Medcycle ensures ongoing production and provides up-to-date GMP know-how. GMP compliance and product quality are maintained.
Fill management positions on a temporary basis
Head of Quality Control or Technically Responsible Person (FvP) are key positions in every pharmaceutical company. If they leave the company at short notice or have to switch to another position for a certain period of time, they leave a vacancy that has to be filled quickly and reliably. Medcycle has people who can fill these key roles under Swiss law and helps them as a company to master this critical situation.
Well-founded GMP know-how and competence in quality assurance
With many years of experience in on-site support, Medcycle knows what is important. Employees can provide support with all quality assurance tasks, such as
- Qualification of technical plant and equipment
- Qualification documentation such as B. DQ, IQ, OQ, PQ logs and reports, SOPs, URS
- Risk analyses
- FAT / SAT support
- Coordination of qualification activities
- Review of technical documents and drawings
- Processing and monitoring of changes and deviations
- Periodical reviews and batch record reviews
- Process, method and cleaning validation
- Data integrity
- Method transfer
GMP-experienced employees and fast responsiveness
The entire process of selecting potential candidates usually has to be very quick. Due to its own project work, Medcycle knows exactly which qualification profiles are required and which skills the employee must have. Individual training courses and regular exchanges with the in-house GMP experts provide a good basis for supporting the customer in balancing cost-effectiveness and quality requirements. And through the strategic combination of compliance consulting, project management and on-site execution, the customer not only receives manpower but also up-to-date GMP know-how on top.