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SII Group is a trusted technology partner, SII provides high value added solutions for the IT projects of many large corporations. Since its founding in 1979, the Company has been providing solutions adapted to its clients’ needs, by relying on :
* Its acknowledged expertise in various industries and sectors
* Proven 'turnkey' solutions
* Adaptable, evolving services
Today, with a staff of more than 18'000, SII Group is supporting companies across 20 countries.
At SII Switzerland we pay attention to the personal and professional wellbeing of our employees. We place our collaborators at the heart of our actions and activities. If you are motivated by the perspective of joining a big, trusted and recognized group, then let's meet !
To develop our consulting offer and support one of our clients, we are looking for a talented MS&T Lead Investigator.
Missions
* Facilitate triage of deviations to assist deviation owners to define need for investigations
* Supports initial impact/risk assessment for all deviations in conjunction with Quality Operations
* Lead and conduct investigations until conclusion and ensures that the investigation outcome, root cause analysis and execution of corrective and preventive actions are completed in a timely, effective and compliance manner. Investigation scope may be related to bulk operations, packaging operations, warehouse, or maintenance processes
* Partner with quality assurance and impacted departments (production, quality control, warehouse, maintenance, etc) to ensure investigations are exhaustive
* Provide appropriate level of reporting and communication on the assigned investigations, at site and global levels (Investigation Review Board, pharma MS&T reporting)
* Share good practices within the site and with other sites
* Perform complaint investigations
* Contribute to continuous improvement, including proactively identifying problems, gathering input from the operational team and proposing solutions
* Participate to or lead projects and initiatives within MS&T team
* Provide support to other MS&T teams (such as robustness, qualification,...) as required
* Execute tasks as assigned
Profile
* BS/MS in Engineering/Technical discipline or equivalent experience
* At least 5-8 years’ experience in pharmaceutical operations, validation, quality assurance, packaging or related field, if possible Oral Solid Dosage manufacturing
* Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes
* Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP
* Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc) is a nice to have
* Well-developed ability to constructively work across functional areas and levels to achieve results
* Technical writing skills
* Strong analytical, problem solving, influential and deductive skills
* Capability to work with short deadlines and simultaneous activities
* Excellent organizational and project management skills
For information
* Duration : Long term
* Language : Fluent in English and French
Seniority level
* Associate
Employment type
* Full-time
Job function
* Consulting
* Industries
* IT Services and IT Consulting
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Specialist / Investigator MSAT - Pharmaceutical Manufacturing Development - French speaking - 6 months temporary contract / 100% office based (Ref. 2671)
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