Job Description

Scientifique / Scientist

Job Location:

Laval, Quebec, CAN

Job Requisition ID:

13579
Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence.



We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.



We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it--where your skills and values drive our collective progress and impact.


Description de poste




Titre du poste : Scientifique

(Validation)

1. Finalite du poste (but, raison d'etre du poste)




Effectuer les transferts, les verifications et les validations de methode analytiques tant chimiques que physiques pour des matieres premieres, ainsi que des produits finis.


Effectuer l'optimisation (life cycle) des methodes d'analyses, ainsi que le travail de validation necessaire de revalidation tant chimiques que physiques pour des matieres premieres, des produits finis.


Effectuer les analyses chimiques ou physiques des matieres premieres, des produits finis, et des stabilites par des methodes connues et officielles dans le but de determiner la qualite d'un produit ou de suivre un procede de fabrication Effectuer les analyses reliees aux activites du laboratoire en respect des regles HSE et de la conformite aux BPF, BPL et autres guides et standards en vigueur. Participer aux activites du laboratoire reliees aux qualifications de methodes officielles connues, de procedes de fabrication, des equipements et residus de lavage



2. Fonctions principales




Optimiser et valider des methodes d'analyse en HPLC et GC. Participer au transfert analytique des methodes d'analyse connues et officiellement approuvees Effectuer les analyses chimiques, physiques et instrumentales selon les methodes connues, officiellement approuvees pour determiner la qualite des produits sous analyse ou de suivre un procede de fabrication (analyse pour validation de procede) Effectuer le suivi approprie sur les analyses chimiques Completer avec diligence la documentation d'analyses executees selon les normes et procedures en vigueur (BPF, BPL, LIMS, investigations, etc) Participer aux differents projets du service + Investigations et reprises d'analyse suite a l'obtention des resultats atypiques
+ Qualification et calibration des instruments de laboratoire
+ Analyse des echantillons de validation de procedes de fabrication et des stabilites reliees aux projets
Participer a divers projets speciaux selon les besoins du departement Participer a la redaction de procedures et / ou de manuel d'operation, au besoin Est garant du maintien de ses qualifications techniques et de sa connaissance des methodes et procedures en vigueur Effectuer la calibration des equipements dont il a usage selon les programmes appropries et dont il possede les connaissances et les competences appropriees Effectuer son travail dans le respect des normes, politiques et procedures BPF, BPL et HSE en vigueur dans l'entreprise S'assurer de maintenir son poste de travail propre, selon les BPL et les exigences HSE Assurer la disponibilite du materiel necessaire a l'execution de ses taches.



3. Responsabilite de gestion




Effectue les analyses de laboratoire (chimiques ou physiques) reliees aux differents produits et aux differents projets analytiques selon les methodes connues, officiellement approuvees pour determiner la qualite des produits sous analyse ou de suivre un procede de fabrication (analyse pour validation de procede). Effectue l'optimisation et la validation de methode d'analyse. Il est donc responsable de la gestion de ses taches d'analyse et leur execution et du respect de leur echeanciers.



Agir comme personne ressource lors de problemes analytiques sur les lests qu'il execute et/ou support a l'utilisation des instruments de laboratoire, la ou applicable

4. Ressources (moyens)

Aucun budget a gerer. Les depenses a engager sont la responsabilite du chef de service

5. Principales relations professionnelles

(internes / externes)

Partenaires internes

: Le service de Laboratoire et le service des achats, dans la coordination de leurs activites de travail

Partenaires externes

: Fournisseurs de services en analyses de laboratoire

6. Connaissances et competences requises :

a) Formation requise

Baccalaureat en Chimie, Biochimie

b) Langues

Francais requis. Anglais un atout.

c) Experience et connaissances particulieres

5 a 7 ans d'experience en optimisation et validation de methode


Experience avec Empower


Experience en laboratoire d'analyse de produits pharmaceutiques


Connaissance des normes BPF / BPL canadiennes et internationales


Excellente connaissance des techniques analytiques et instruments de laboratoire (HPLC et GC)


Membre de l'ordre des chimistes

d) Competences techniques specifiques

Chimie analytique


Instrumentation au laboratoire


Metrologie


Systemes d'informations de gestion : (LIMS, Empower, etc,...)



*









Position title: Scientist

(Validation)

1. Purpose of the position




Perform transfers, verifications and validations of both chemical and physical analytical methods for raw materials and finished products.



Perform optimization of analytical methods and validation work, both chemical and physical, for raw materials, finished products.



Perform chemical or physical analyzes of raw materials, finished products, and stabilities by known and official methods in order to determine the quality of a product or to follow a manufacturing process



Perform analyzes related to laboratory activities in compliance with HSE rules and compliance with GMP, GLP and other guides and standards in force.



Participate in laboratory activities related to the qualifications of known official methods, manufacturing processes, equipment and washing residues



2. Main duties




Optimize and validate HPLC and GC analysis methods



Participate in the analytical transfer of known and officially approved analytical methods



Perform chemical, physical and instrumental analyzes according to known, officially approved methods to determine the quality of products under analysis or to follow a manufacturing process (analysis for process validation)



Perform the appropriate follow-up on chemical analyzes



Diligently complete the documentation of analyzes carried out according to the standards and procedures in force (BPF, GLP, LIMS, investigations, etc.)



Participate in the various departmental projects



Investigations and re-analyzes following the obtaining of atypical results



Qualification and calibration of laboratory instruments



Analysis of validation samples of manufacturing processes and stabilities related to projects



Participate in various special projects according to the needs of the department



Participate in the drafting of procedures and / or operating manual, as needed



Is responsible for maintaining his technical qualifications and his knowledge of the methods and procedures in force.



Calibrate the equipment he uses according to the appropriate programs and for which he has the appropriate knowledge and skills

Perform their work in compliance with GMP, GLP and HSE standards, policies and procedures in force in the company



Make sure to keep his workstation clean, in accordance with GLP and HSE requirements



Ensure the availability of the equipment necessary for the performance of its tasks.

3. Management responsibility

Performs laboratory analyzes (chemical or physical) related to different products and different analytical projects according to known, officially approved methods to determine the quality of the products under analysis or to follow a manufacturing process (analysis for process validation). Performs analysis method optimization and validation. He is therefore responsible for managing his analysis tasks and their execution and respecting their deadlines.




Act as a resource person during analytical problems on the weights that he or she executes and/or support the use of laboratory instruments, where applicable

4. Resources (means)

No budget to manage. Expenses to be incurred are the responsibility of the department head

5. Main professional relationships (internal/external)

Internal partners: The Laboratory department and the purchasing department, in the coordination of their work activities




External partners: Laboratory analysis service providers

6. Knowledge and skills required:

a) Required training

Bachelor of Chemistry, Biochemistry

b) Languages

French & English

c) Special experience and knowledge

5 to 7 years of experience in method optimization and validation


Experience with Empower


Pharmaceutical analysis laboratory experience


Knowledge of Canadian and international GMP / GLP standards


Excellent knowledge of analytical techniques and laboratory instruments (HPLC and GC)


Member of the Ordre des Chimistes

d) Specific technical skills

Analytical Chemistry


Instrumentation in the laboratory


Metrology


Management information systems: (LIMS, Empower, etc, ...)




The masculine is used in this publication without prejudice for the sake of conciseness.

Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.