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Quality Assurance Specialist

4 months ago

SaintLaurent, Canada Groupe Parima Full time

**Quality Assurance Specialist - CSV & Conformity**

The _**Quality Assurance Specialist - CSV & Conformity**_

From a quality assurance standpoint:

- Manage the data integrity program.
- Oversee the validation full lifecycle of software systems, ensuring they operate in compliance with cGMP, 21CFR11, GAMP5 requirements
- Manage the audit program (client and internal audits) - (active participation to regulatory inspections) and CAPA Program.

**Responsibilities**:

- To put in place and maintain a procedure related to data integrity and ethical code of conduct for Groupe Parima employees.
- To ensure that the data integrity principles, ALCOA, etc, are communicated and consistently followed by all employees working in the GxP areas.
- To provide an annual training to Groupe Parima employees on data integrity
- Oversee, from a quality assurance standpoint, the conformity of the quality system and the adherence to procedures and working instructions.
- ________________________________
- To work with the senior CSV Manager to provide guidance on CSV documentation requirements and approaches.
- To work with the CSV Manager to generate lifecycle CSV deliverables for each electronic system, including validation assessments and plans, risk assessments, software and configuration testing, reporting, and change management.
- To put in place and maintain a procedure to establish the verification frequency of audit trails for GxP systems.
- To review and approve the CSV documentation.
- _________________________________
- To act as the principal host during the client audits and to actively participate to regulatory inspections (HC & FDA).
- To manage the internal audit program including the internal audit of the IT Department.
- To manage the CAPA programme: monitor and follow-up of deadlines and contact person to help departments implement CAPA.
- To actively participate in employee training
- Other relevant tasks

**Skills and experience required**:

- BSc (Chemistry, Biochemistry, Microbiology), or a related discipline, from a Canadian university or diploma recognized by a Canadian university or accreditation body as equivalent in a scientific field.
- Minimum of five (5) years of experience in Quality Assurance in the pharmaceutical industry, with experience in IT system validation, audits and quality systems:

- Minimum of 5 years of applied CSV experience in the pharmaceutical or medical device industry.
- Expertise in electronic quality management systems (QMS), QMS product management, and systems validation.
- Excellent knowledge in system integration methodologies and tools.
- Thorough knowledge and understanding of Canadian (Health Canada), American (FDA) and European Good Manufacturing Practices (GMP)
- Knowledge and thorough understanding of data integrity principles and computer system validation (21CFR11, GAMP5)
- Technical and regulatory expertise in information technology systems supporting GxP activities
- Good knowledge of ICH Q9 and Q10 (Risk Management and Quality System)
- Excellent communication skills. Excellent ability to interact with auditors, clients, employees and managers
- Excellent technical writing
- Bilingual (French and English).
- Able to work in a demanding environment and meet deadlines
- Team player

**What we offer**:

- Medical - dental & travel benefits
- Group retirement plan
- Recognition program & social activities
- Personal days
- Employee assistance program & online medical service
- Hot Beverages (Hot chocolate, Coffee, Mokaccino)
- Accessible by public transit or free parking
- Referral program
- Subsidized meal program

Type d'emploi : Temps plein, Permanent

Avantages:

- Assurance Dentaire
- Assurance Invalidité
- Assurance Maladie Complémentaire
- Assurance Vie
- Congés payés
- Événements d'Entreprise
- Nourriture à Prix Réduit ou Gratuite
- Programme d'Aide aux Employés
- REER Collectif
- Stationnement sur place

Horaires de travail:

- Du Lundi au Vendredi

Expérience:

- Assurance qualité: 5 ans (Obligatoire)

Lieu du poste : En présentiel