Le poste Analytics Data Management Scientist
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Specification change leader
Ensure global specification requirements are translated into local specification requirements
Management of local specifications to allow laboratory testing and Product Release
Ensure local specifications are compliant with the market and regulatory requirements
Deliver projects linked to the AP&O department (ea. projects related to Glims, Digital 4.0, and process improvement).
LIMS statics data configuration
Configuration and qualification of statics data related to specification, methods, sampling plan, etc. within the LIMS
Manage local specifications changes (creation/update) according to procedures in place and business needs.
Coordinate the creation/review of the specification ensuring that the content is defined and developed with the involvement of the appropriate experts/stakeholders to grant compliance to regulations and related files.
Checks the progress of the change with stakeholders and escalates any risks in the initially planned implementation schedule.
Ensure communication between subject matter experts and stakeholders. Ensure all information is provided to the specification author to write a local specification document in ECMS.
Informs Lim’s partner when the specification is in status issued in ECMS and ensures to provide time-specific information allowing Lims configuration /process to operate with efficiency.
Ensure planning and coordination to satisfy the client’s needs. Organize or participate actively in weekly/monthly planning meetings, propose solutions, and demonstrate creativity and pro-activity to ensure adherence to plan and performance.
Ensures local specification implementation is in alignment with global specification status.
Lead and ensure delivery on time and within the budget of projects from beginning to end.
Organize project’s structure and governance, manage related meetings (Steering Committee, Core Team, Streams)
Collaborate with IT & vendor project managers to coordinate the activities of our client.
Business stakeholders (subject matter experts, compliance & QA representatives from discovery, technical development, and quality control departments),
IT teams (system owners, infrastructure, security, validation, etc.),
External partners (e.g., Labware experts).
Being influential, make sure that everyone appropriately contributes to the delivery of the project on time, in full, and with quality (incl. proper reporting, risk & issue management).
More specifically, lead the gathering & formalization of user requirements (incl. process & data flows and metadata management), the acceptance testing & performance qualification of the delivered solution, and the training of end-users, guaranteeing that our needs are properly defined (and aligned across departments) and supported by the final product.
LIMS static data configuration
Develop system knowledge and ensure:
Configuration of specification/method/sampling plan within the LIMS (creation/update)
Qualification of static data configuration
Implement, follow-up, and communicate on KPI.
Ensure the continuous improvement of the activity.
Ensure update or creation of related procedures and instructions.
Ensure follow-up of corrective actions and preventive actions. Ensure audit readiness, and participate in the preparation, the follow-up, and the realization of audits.
Ensure the follow-up of deviations and appropriate root cause analysis to address the right action plan.
Apply the company’s Health and Safety policy
Ensure a safe working environment to meet site safety objectives
The position can act as a back-up for his direct colleagues or manager after appropriate training.
Education and technical skills
Master/engineer in sciences (chemistry, physics, biology, Pharmacist, Bioinformatics).
Must have proven experience (min 2 to 3 years) in a GMP / laboratory environment.
A knowledge/ experience in data management/Lims/SAP as Key users/specification management/ monography development/ Project management is an asset
Profil du candidat
System-minded: understand quickly how systems functionalities can support business requirements
Project management skills: ability to evaluate staffing and means versus project workload and translate into a clear action plan with an appropriate follow-up is essential. Must be able to manage multiple projects at the same time.
Operational excellence and compliance should be the ’must’ reference for any operational decisions.
Capable to make one’s proper decisions by utilizing strong analytical skills and a problem-solving approach.
Good knowledge or experience in specifications management
Excellent interpersonal, verbal, and written communication skills
Strong written and oral communication skills, Fluent in English / French
Key technical backgrounds: QC laboratory, analytical techniques (such as HPLC, GC, ), and data management/analytics
Proven experience in the use of LIMS software is an asset
SQL language, LIMS BASIC is an asset
Proven experience related to deviation management is an asset
Proven project leadership skills including planning, monitoring, issue resolution, investigations (DMAIC, 5M, etc), decision making, and reporting
Strong organization skills
Team player and open to new ideas
Always striving for continuous improvement
Think transversally end to end
Analytical mindset with a capacity to see the bigger picture
Self-driven, results-oriented with a positive outlook and a clear focus on high quality
Fluent in English and French
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