Job Description & How to Apply Below
About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
For more information visit:
Job Summary - RÉSUMÉ DU POSTE :
Responsible for incoming material and finished product release
Responsible for handling quality complaints and annual product quality reviews
Responsible for managing Change Control, Investigation/OOS and CAPA programs
Responsible for interacting with suppliers and clients on quality matters
Responsible for documentation and records management according to internal procedures
Responsable de la libération des matières premières et des produits finis
Responsable du traitement des plaintes qualité et des revues annuelles de la qualité des produits
Responsable de la gestion des programmes de Contrôle des Changements, Investigations (Plaintes, Deviations et OOS) et MCMP.
Responsable des interactions avec les fournisseurs et les clients sur les questions de qualité
Responsable de la gestion de la documentation et des enregistrements selon les procédures internes
Job Responsibilities
Incoming Material and FInished Product Release Perform the verification of all documents required to release incoming materials for use in production, where and when applicable
Perform the verification of all documents required to release finished products.
When applicable, request additional testing samples or perform any additional steps required to evaluate the quality of the product/material.
When applicable, ensure that product stability studies are initiated and conducted at appropriate intervals and that documentation is available at Searchlight.
Quality COmpLAINT HANDLING AND APQR Log, track and evaluate the quality complaints and ensure adequate communication and timely follow ups with clients and suppliers
Work with the assigned third party for Adverse Event reporting
Ensure adequate investigation
Define appropriate CAPAs
Track, evaluate and dispose of products returned by the clients where applicable
Schedule, request, perform and complete annual product quality reviews as per internal procedure and in collaboration with other Searchlight departments and suppliers
QUality EVENTS, CAPA and CHANGE CONTROL Handling Ensure timely creation , tracking and closure of quality events, CAPA and change control
Perform or assist other departments in problem identification, immediate actions, root cause analysis and CAPA identification
Track related quality system key performance indicators (KPI)
Train employees on quality systems program
Ensure timely creation, tracking and closure of quality events, CAPA and change control
Review closed quality events, CAPA and change control, and ensure proper documentation
DOCUMENT CONTROL Ensure timely review and implementation of SOPs and other QMS documentation
Ensure master product documentation is available and current per internal procedure
Follow up and ensure quality events are processed according to required timelines
OTHERS Any other tasks as required by the QA manager or delegate.
Responsible for reporting adverse events associated with Searchlight products.
RESPONSABILITÉS PRINCIPALES:
LIBÉRATION DES MATIÈRES PREMIÈRES ET DES PRODUITS FINIS Vérifier tous les documents requis pour la libération des matières premières destinées à la production, lorsque cela s’applique
Vérifier tous les documents requis pour la libération des produits finis
Le cas échéant, demander des échantillons supplémentaires pour essais ou effectuer toute étape supplémentaire nécessaire à l’évaluation de la qualité du produit/matériau
Le cas échéant, s’assurer que les études de stabilité des produits sont lancées et menées à intervalles appropriés et que la documentation est disponible chez…
Note that applications are not being accepted from your jurisdiction for this job currently via this jobsite. Candidate preferences are the decision of the Employer or Recruiting Agent, and are controlled by them alone.
To Search, View & Apply for jobs on this site that accept applications from your location or country, tap here to make a Search:
To Search, View & Apply for jobs on this site that accept applications from your location or country, tap here to make a Search:
Search for further Jobs Here:
×