AKKA Life Sciences is a pan-European professional services consultancy with offices in Germany, Switzerland, Spain, France, Belgium and Italy providing Pharma Engineering resources to global Life Science clients. With over 750 consultants across Europe.
We are actively looking for
Qualification & Validation Manager
to join our practice on a permanent basis.
We can offer you roles for our global clients in Ticino area.
· Advise project teams, develop/review and approve validation protocols and final reports
· Manage Change Control on material specifications and documentation, develop and validate test method validation (Gage R&R)
· Support/conduct FAT/SAT and then IQ/OQ/PQ validation studies of equipment and processes, utilities and software validations
· Support of continuous improvement on process, and on Qualification and Validations project
· Maintain equipment to support GMP manufacturing ensuring all equipment complies with Standard Operating Procedures and Policies
· Participate in project planning, scheduling, and tracking
· Develop and implement procedures to comply with corporate and industry standards
· Provide validation training to Operations employees
· Degree in Life Sciences, preferably in pharmacy or chemistry or equivalent;
· Minimum 7 years of experience in Qualification / Validation in the Pharmaceutical industry
· GMP background ; Pharmaceutical Quality Assurance
· Applied knowledge of FDA and international Pharmaceutical regulations is preferred
· Applied technical understanding of manufacturing equipment (autoclaves, washing machines...); processes specific to Pharmaceutical manufacturing preferred
· Applied Knowledge of creation and verification of qualification equipment plans (FAT/SAT/DQ/IQ/OQ/PQ)
· Demonstrated problem solving and troubleshooting skills
· Languages: Italian and English fluent and French is clearly a plus
· A permanent contract with a European leader in innovation and high-tech engineering consulting
· A steep learning curve due to diverse and cross-industrial project opportunities
· An open and constructive corporate culture with over 14,000 colleagues in over 20 countries.
· Global projects & global job opportunities
If this sound like your next challenge, please send me your updated CV