Qc Technical Services Specialist

2 weeks ago


Montréal, Canada Grifols Full time

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
**Position Title**: QC Technical Specialist **Reports to**: QC Manager

**Position Summary**

The QC Technical Specialist is responsible for the qualification of computer system validation (CSV) of QC lab systems, and to coordinate the maintenance and calibration programs for systems in operation at the QC Laboratories at Grifols Canada Therapeutics Inc. The responsibilities for this position require a strong background in laboratory instrumentation and computerized systems in order to support the validation lifecycle of complex systems in the GCT QC Laboratory.

**Key Duties and Responsibilities**
- Provides the expertise required to generate installation/operation/performance qualifications for sophisticated QC laboratory instrumentation (TOC, HPLC, GC, IR, UV-VIS, IC, Karl Fischer, MALDI Biotyper, Endotoxin System, NIR) and related software.
- Perform risk and impact analyzes for IT systems.
- Generates IQ/OQ/PQ and validation reports for QC instrumentation and related software.
- Reviews and revises standard operating procedures for technical accuracy and compliance with regulatory requirements.
- Understands, programs and prepares the validation tests for the calculations to be supported by the software.
- Participate in periodic review and storage activities of GxP software.
- Notifies QC management of any potential quality issues related to test validations and provide recommendations for quality improvement
- Assists in the resolution of audit observations related to validations and proposes corrective actions.
- Provides guidance and recommends validation strategy, approaches for the Computerized systems in the QC Laboratory.
- Prepare change control documents related to laboratory software.
- Develops documents required for 21 CFR part 11 compliance, including URS, validation plans, qualification protocols and summary reports for the QC computerized systems.
- Coordination of the instrument maintenance and spare parts inventory as well as coordination with vendors and with the instrumentation group.
- Help to the implementation of the different System into LIMS or equivalent Laboratory Management System.
- Ensure compliance with regulatory requirements and quality procedures (Qualification and Validation).
- Participates in the creation or revision of procedures and training documents for the use of software of the QC instrumentations.

**Qualifications**:

- B.Sc. or M.S. (preferred) in Biochemistry, Physics or a Life Sciences field
- Requires five to six years of experience working in a laboratory, at least two of which should be in a cGMP environment such as is found in the pharmaceutical or biotech industry. Prefer individuals with experience in laboratory computerized systems, instrumental analysis and laboratory method validation.
- Strong communication, interpersonal, organizational and decision-making skills. Strong technical writing skills. Requires a fundamental understanding of analytical methodology, Requires an advanced knowledge and skill level for computerized systems used with laboratory equipment.
- Knowledge of GMP as well as pharmacopeia (USP, BP, EP) to support products intended for the Canadian, US and European markets.
- Good understanding and Knowledge of the data integrity
- Bilingual English/French.

**Titre de la position**: spécialiste technique control Qualité **Se rapporte au**: Chef Control Qualité

**Sommaire de la position**:
Le spécialiste technique control Qualité (QC) est responsable de la validation des systèmes informatique du laboratoire de control de Qualité de Grifols Canada Thérapeutiques Inc. Les responsabilités de ce poste nécessitent une solide expérience des instrumentations du laboratoire et les systèmes informatiques afin de soutenir le cycle de vie de validation de ces systèmes au Laboratoire.

**Tâches et responsabilités**:

- Fournir l'expertise requise pour générer les protocols de qualifications d’instalation de fonctionnment et performances des instruemnts de laboratoire QC et leurs logiciels
- Effectuer des analyses de risque et d’impacts pour les systèmes informatiques
- Génèrer les rapports IQ/OQ/PQ et de validation pour les intruements QC et des logitiels les pilotants.
- Revise les procédures standards pour l'exactitude technique et la conformité aux exigences réglementaires.
- Comprends, programmes et prépare les tests de validation pour les calculs devant être pris en charge par le logiciel
- Participe à la revue pé



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