Validation Specialist

Upton, Quebec.

Introduction

We are hiring for our client who operates in the pharmaceutical industry, and we are seeking a Validation Specialist who will be responsible for carrying out all the steps leading to the validation of manufacturing, packaging equipment, processes, and systems associated with the production of pharmaceutical products in a sterile environment.

Our client has been manufacturing, packaging, and distributing sterile ophthalmic pharmaceutical products for the Canadian and international markets for over 15 years. The company has around 40 employees and is located in Upton, Montérégie.

Furthermore, our client is a growing company where you can develop your skills in a controlled work environment where the quality of your work positively impacts the product and outcome of stakeholders while offering you excellent working conditions and job stability.

Responsibilities

Develop validation protocols to meet regulatory expectations from the FDA and Health Canada.

Execute validation protocols according to the validation schedule, requalification, and the site master plan (including validation of equipment, cleaning, processes, and the computer system).

Improve validation systems to comply with global and industry standards.

Draft corresponding validation reports.

Identify opportunities for improvement.

Provide technical support to operations.

Ensure the integrity and traceability of the information produced and reported, making necessary corrections in compliance with GMP and the company's internal standards.

Perform document review, including revising and correcting internal documents (SOPs, IT, etc.).

Requirements

Bachelor's degree, ideally in the sciences.

Over three years of experience in validation within a GMP-regulated environment (pharmaceutical or food industries).

One-plus years of experience in sterile pharmaceutical environments.

Strong knowledge of GMP (Good Manufacturing Practices) and Good Documentation Practices.

Good problem-solving abilities.

Excellent ability to meet deadlines and manage priorities.

Strong technical and documentation rigor.

Foundational knowledge of Microsoft Office Suite (Word, Excel).

Proficiency in written and spoken French.

Strong proficiency in written and spoken English.

What We Offer

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