On behalf of our client, a growing company based in Neuchâtel, we are currently looking for a
QC Specialist – Compliance & Continuous Improvement
Vos tâches
POSITION SUMMARY
This position is part of the team “Compliance & Continuous improvement” within Quality Control Laboratory of BMS
Boudry site.
The Specialist QC “Compliance & Continuous improvement supports the program implemented by the Manager to
maintain a reliable, qualified, and regulatory compliant operation with a project and continuous improvement strategy
for Boudry QC Laboratory.
The QC Specialist – Compliance & Continuous Improvement will be required to support inspections (including but not
limited to internal, corporate, and regulatory audits) and QC Management to fix associated observations.
This position also coordinates change control evaluations by bringing process or activity knowledge and centralizing the
assessments from other QC teams impacted to define proper actions. This role will also keep overview of QC change
controls status and actions to ensure in time implementation.
As a knowledgeable system specialist (LIMS, ERP, Document management system, …), this position will participate in
associated projects and support the teams by bringing routine support. In this continuity this role will be the point of
contact to coordinate specific system enhancements, to manage isolated issue, and to provide or coordinate trainings.
As a representative of continuous improvement and experienced collaborator, the Specialist drives specific initiatives
and support Sr Specialist or other QC members for specific activities which aim to continuously increase QC Laboratory
compliance and performance. This position will be required to participate in coordination meetings, to update
documents, to support investigations, or to execute any other actions to ensure Laboratory and Site success.
This position is the back up of Sr Specialist “QC Compliance & Continuous improvement” and can be assigned other
tasks related to other QC responsibilities.
DUTIES/RESPONSIBILITIES
Support Compliance in accordance with global cGMP regulations and BMS policies
Support regulatory inspections and internal audits
Assist implementation of associated action
Coordinate & support change control assessment and related activities
Support Risk assessment and Data integrity initiatives for QC processes
Act as QC representative for Projects or support implementation
Bring technical & process knowledge to ensure proper Projects implementation
Participate in cross functional meetings
Communicate and escalate main information or issues highlighted
Execute specific tasks according to Projects needs
Support Continuous Improvement initiatives within laboratories
Maintain QC performance data tools implemented
Implement actions defined as part of performance data analyze
Support implementation of LEAN programs (5S, Gemba, Pareto, Tiers, Gemba …)
Support QC improvement initiatives
Facilitate System usage for Laboratory teams (LIMS, ERP, …)
Act as an experience collaborator for the Lab
Act as a delegate of Sr Specialist “Compliance and Continuous Improvement”
Create & update procedures or other documents
Promotes safe practices and behaviors
Reports immediately all incidents to EHS, participate in investigations and identify measures to prevent similar
accidents in the future.
Other tasks can be assigned
Votre profil
REQUIRED COMPETENCIES:
Federal Certificate of Capacity as Laboratory Technician or similar education in Microbiology, Biology,
Chemistry, Pharmacy or similar.
Minimum of 2 years of QC experience or related cGMP laboratory experience in the pharmaceutical industry
Knowledge of Quality Control Laboratory processes
Knowledge of Lean principles and tools (5S, Pareto, Visual management, …)
Good technical writing & verbal communication skills
Good proficiency in common oice software
Knowledge of solid oral dosage forms (capsules and tablets) analytical methods
Fluent in French and basic English skills (verbal and written)
Abilities in organizing, planning, priority setting and time management
Ability to work collaboratively and cross-functionally with peers
Date d'entrée
À convenir