7 meilleures offres (qa & system validation, columbus) (à pourvoir)

Document Reviewer II - QA - Afternoon
Thermo Fisher Scientific —Whitby, ON
- De 50 800 $ à 70 000 $ par an
- Temps plein
- Anglais
- Microsoft Office
- Baccalauréat
Manager, Platform Technology
goeasy —Pickering, ON
- De 99 187,50 $ à 138 000,00 $ par an
- Informatique
- PMP
- Maîtrise
- Bourses d'Études
Postuler rapidement
Electrical Quality Control Inspector
Aecon Group —Pickering, ON
- De 45 $ à 55 $ de l’heure
- Fins de semaine au besoin
- Microsoft Office
- Compétences en informatique
- Construction et rénovation
Junior QA Hardware Tester - Pickering
Lenbrook Group of Companies —Pickering, ON
- De 45 000 $ à 47 000 $ par an
- Temps plein
- Windows
- Réseaux informatiques
- En présentiel
- Assurance Invalidité
- Assurance Dentaire
Postuler rapidement
il y a 6 jours
Mechanical Quality Control Inspector (Evergreen)
Aecon Group —Pickering, ON
- De 45 $ à 50 $ de l’heure
- Nuits au besoin
- Microsoft Office
- Compétences en informatique
- Construction et rénovation
Civil Quality Control Inspector
Aecon Group —Pickering, ON
- De 45 $ à 55 $ de l’heure
- Fins de semaine au besoin
- Microsoft Office
- Compétences en informatique
- Construction et rénovation
Senior Maximo Systems Developer-Integrator
Finney-Taylor Consulting Group —Canada
- Contrat
- Oracle
- Maintenance
- Bases de données
il y a 3 jours

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Verification & Validation Manager - Medical Devices
CMC Recruitment Solutions Inc. —Markham, ON
Thorough understanding of traceability between risks, product requirements, product design, implementation, test procedures, test results, and risk mitigations.
De 110 000 $ à 120 000 $ par an
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il y a 2 jours
QA Specialist
FUJIFILM —Toronto, ON
Key responsibilities include project testing activities, documentation of test cases, review of requirements and design documentation, execution of integration…
De 65 000 $ à 80 000 $ par an

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Document Reviewer II - QA - Afternoon

Thermo Fisher Scientific -
Whitby, ON

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Détails du poste

Temps plein
De 50 800 $ à 70 000 $ par an

Profil recherché

Systèmes de gestion des informations de laboratoire
Anglais
Microsoft Office
Baccalauréat
Sens de l'organisation
Chimie
Compétences en informatique
Production
Compétences en communication

Description complète du poste

Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Summary:

Responsible for reviewing all data, lab notebooks, and completed Certificates of Analysis (C of A) and Stability reports generated in the Laboratory. Verify and confirm the integrity and traceability of all data generated and reported.

Essential Functions:

Review all regular technical documents (e.g., batch testing, stability testing, method development and validation, raw materials and packaging components) and raw data generated in the Laboratory with high quality and deliver within standard time.

Review and approve TrackWise OOS/DRs generated by laboratory

Release Raw Material and Packaging Components in SAP

Release of Product Certificate of Analysis using applicable LIMS software

Ensure the test methods, protocols and Standard Operating Procedures (SOPs) have been followed by the scientists/chemists.

Verify the integrity and traceability of all data generated and reported.

Follow up with scientist/chemists to ensure that all necessary corrections are corrected in accordance with Good Manufacturing Practices’ standards.

Notify department supervisor/manager regarding omissions, incomplete testing results or other irregularities.

Write/Update SOPs and initiate change control when necessary.

Adhere to assigned schedules and standard times.

Maintain a safe working environment and report potential hazards.

Perform alternating or rotating shift work (as required).

REQUIRED QUALIFICATIONS

Education:

Bachelor of Science in Chemistry or related science.

Experience:

Minimum 3 years of previous pharmaceutical analytical development experience.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities:

Basic understanding the common analytical technologies (e.g., High Performance Liquid Chromatography (HPLC), Gas Chromatography, Ultraviolet (UV) spectroscopy, and titration. Knowledge in Empower, LIMS Nugensis and Trackwise software. Excellent written and oral communication skills. Good working knowledge of Good Manufacturing Practices, International Conference of Harmonization (ICH) and United States Food & Drug Administration (FDA) requirements. Strong organizational skills and detail oriented. Ability to meet deadlines and prioritize. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.

Standards and Expectations:

Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality SOPs and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.

Physical Requirements:

Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.

Compensation

The estimated annualized pay range for this position in Ontario is $50,800.00–$70,000.00.

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qa & system validation emplois - columbus

Document Reviewer II - QA - Afternoon

Manager, Platform Technology

Electrical Quality Control Inspector

Junior QA Hardware Tester - Pickering

Mechanical Quality Control Inspector (Evergreen)

Civil Quality Control Inspector

Senior Maximo Systems Developer-Integrator

Explore jobs in cities nearby

Je souhaite recevoir la dernière alerte emploi pour les postes de ce type : qa & system validation (columbus)

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