Amaris is an independent, international Technologies and Management Consulting Group. Created in 2007, Amaris is already established in over 50 countries and supports more than 850 clients worldwide throughout their project's lifecycle. Our expertise covers five areas of innovation: Business and Management, Information Technologies, Engineering and High Technologies, Telecommunications and Biotech and Pharma. With more than 65 offices across the world, the Group offers proximity support to its clients in all their locations and many opportunities of international careers for employees.
This full-time position will cover the main Commissioning, Qualification and Validation duties. You are specialised in Clean utilities or Bioprocess Upstream Downstream final purification or QC or Cleaning Validation or CSV. As a leader, you will supervise the project with the Project Manager.
Role and Responsibilities:
cGMP & Quality Management Systems Consultancy firm; specialises in providing support to Life Science & Healthcare
Manufacturers in the area of cGMP compliance, critical requirements definition, and quality management systems
For a new green research & development plant, with latest technologies implementation and
With the help/supervision of the Project Manager Senior/CQV Manager, he will be in the situation to manage these several tasks on the dedicated speciality:
· Respect of the Governance Documentation (Planning, Risk Strategy, Procedures).
· Involvement and review of the Design documentation for GxP Systems.
· CQ&V Documentation (URS, RTM, DQ, FAT/SAT, IQ, OQ) generation/supervision.
· Risk Analysis/Assessment
· Critical Impact Assessment (Systems, components…)
· GMP Review
· Management of the “on site” realisation
· Management of third parties
· Report to the client and to the partners
· Report to the CQV Manager
Personal investment in the project to show the example to the team.
No recruitment agencies please