Job Description

Job Description / Description de Fonction
Name of Job Holder / Nom du titulaire du poste :
Job Title / Titre de la Fonction :
QA Specialist
Department / Département :
Quality Affairs
Job Origination Date / Date de création :
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November 2014
Version :
01
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Role summary / Résumé du poste:
The present position will perform the following activities: / Les activités suivantes sont réalisées:
The Senior Quality Assurance Specialist will be working as part of the Quality Assurance team on site
ensuring products are manufactured, stored and packaged in accordance with cGMP.
He / she will also support the development of GMP training packages and delivery of training.
Under the direction of the reporting manager, continuously improve QA and Compliance systems, strengthen
quality awareness and investigate quality issues using applicable process improvement and problem solving
techniques to assure successful outcomes of Company and external Health Authority inspections
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The Senior QA Specialist is reporting to Quality Affairs Director
Principle Responsibilities of the Job Holder: / Responsabilités principales du titulaire du
poste
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Job title
Document approval ( procedures, Master Batch Record ,specifications , …)
Review and approval of batch records and associated documentation
Product release
Approval of deviation and support to related investigations
Provide Quality support for investigation of OOS , approve disposition decision
Operate the change control system
Operate the CAPA system
Review / approval of validation protocol / report
Work with relevant departments to ensure timely closure of quality actions / findings
Actively contribute to continuous improvement initiatives.
Perform inspections/internal audits and provide quality oversight for the inspection/ audit
program
Collaborate to supplier qualification
Collaborate with operations to resolve compliance matters
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External and Internal Contacts of the Job Holder / Contacts internes et externes du
titulaire du poste
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Internal Contacts / Contacts internes:
All functions
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External Contacts / Contacts externes:
External auditors , Customers , Suppliers
Key Competencies Necessary to Effectively Perform this Job Role / Compétences
Clés Nécessaires pour Réaliser Efficacement cette position
Minimum qualifications / Qualifications minimum:
Master degree Sciences
Minimum experience required / Expérience minimum requise:
8 years with 3 years in a QA role
Specific skills required / Compétences spécifiques requises:
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Very good knowledge of cGMP in a regulated environment
Knowledge of quality systems
Excellent accuracy and attention to detail
Excellent interpersonal skills
Working knowledge of computer packages
Strong problems solving skills, issue resolution and root cause analysis
Auditing experience, auditor certification is an asset
Highly Flexible and Adaptable. Able to work independently in a fast paced multitasking
environment.
Able to work autonomously
Language : English , French
Validated by HR Service :
Date :
Job title
Validated by Head of
Department :
Date :
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Job Holder :
Date :
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