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Senior Qualification Specialist - Pharmaceutical Manufacturing

posted by: spj_bot

About the Job

As a Gidy Expert Qualification at Excelya, you will be at the forefront of ensuring compliance and qualification for innovative solutions within the biopharmaceutical landscape. This unique role involves a deep understanding of regulatory standards and the application of best practices in qualification processes.

You will work closely with our teams to design, implement, and optimize qualification protocols that align with our clients' needs and maintain the highest quality and safety standards in their processes.

Main Responsibilities:

Job Skills

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QA officer & RSE

posted by: spj_bot

About the Job

Join Excelya as a Quality & CSR Coordinator, where we value Audacity, Care, and Energy in everything we do. In this role, you will have the unique opportunity to oversee quality management systems and contribute to our Corporate Social Responsibility initiatives, promoting excellence and sustainable practices within our organization.

Your focus will include ensuring compliance with quality standards and regulations while actively participating in CSR programs that align with Excelya's vision for creating lasting positive impacts in our community.

In direct contact with internal teams, suppliers and management, you will structure, lead and improve our Quality Management System while deploying concrete actions in favor of the environment, social and ethics.

In this context, your missions will be as follows:

On the Quality side, you will participate in the management:

  • Updating quality documents (procedures, records, etc.)
  • Qualification of suppliers and monitoring of their commitments
  • Internal audits (from planning to reporting)
  • Gap management and CAPAs, with a real root cause analysis approach
  • Preparation of external audits (customers, ISO, etc.)
  • Monitoring and analysis of quality KPIs to detect drifts and propose solutions

On the CSR side, you will contribute to:

Job Skills

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Manager - Tissue and Cell Bank Activities

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work.
We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

We are looking for a Manager – Tissue and Cell Bank to join our dynamic R&D team and oversee activities related to tissues, fluids, tumors, PDX, organoids, lysates, and subcellular fractions.
In this key position, you will drive the development and evolution of the Tissue and Cell Bank in line with the target R&D organization, ensuring excellence in quality, compliance, and operational performance.

Main Responsibilities:

Job Skills

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Safety Project Leader

posted by: spj_bot

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Excelya Pharmacovigilance and Safety department. You will play a critical role in ensuring patient safety and driving excellence in pharmacovigilance, while enjoying a dynamic professional environment that fosters learning, collaboration, and career growth.

The Safety Project Leader is the project manager of the PV & Safety team, responsible for the implementation/provision of the activities/services described within a project/service agreement.

Safety Project Leaders are assuming full ownership of their assigned projects, which means they are fully responsible of regular contact with client and where applicable of budget (including budget forecast), invoicing, all legal issues (renewals, closures, extensions, scope etc.), quality and efficiency as well as audit readiness.

Job Skills

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Clinical Quality Manager

posted by: spj_bot

About the Job

At Excelya, driven by Audacity, Care, and Energy, we invite you to join our team as a Clinical Quality Manager. This pivotal role focuses on overseeing the quality management system within clinical operations to ensure compliance with regulatory requirements and continuous improvement of clinical processes.

As a Clinical Quality Manager, you will lead the development and implementation of quality strategies, manage audits and inspections, and collaborate closely with cross-functional teams to uphold the highest standards in clinical research.

Key Responsibilities

Job Skills

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Pharmacist - Singapore

posted by: spj_bot

The Pharmacist will play a critical role in ensuring the safe, compliant, and effective management of pharmaceutical products across our operations in Singapore. This role ensures compliance with regulatory requirements and Unimed’s Quality Management System (QMS), maintains employee training and compliance records, oversees controlled substance management, and provides product substitutions to meet customer and operational needs while maintaining safety and compliance standards.

  • Minimum 5 years of experience in a pharmaceutical, healthcare, or medical supply environment (international experience a plus).
  • Bachelor’s or Doctor of Pharmacy (PharmD) degree; active license to practice as a pharmacist in [relevant jurisdiction].
  • Strong knowledge of controlled drug regulations and pharmaceutical compliance frameworks.
  • Experience with Quality Management Systems (QMS) in a regulated environment.
  • Excellent organizational skills with attention to detail in documentation and record-keeping.
  • Ability to train, mentor, and oversee staff in compliance-related matters.

Requirements

Quality & Compliance

Job Skills

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IT Business Systems Manager - Quality Systems

posted by: spj_bot

About Jobgether

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

One of our companies is currently looking for an IT Business Systems Manager – Quality Systems in the United States.

As the IT Business Systems Manager for Quality Systems, you will act as the IT System Owner for GxP-regulated platforms such as Learning Management Systems (LMS), Quality Management Systems (QMS), and Electronic Document Management Systems (eDMS). Your role will focus on supporting compliance-related applications and partnering closely with Quality and Validation teams to ensure the successful configuration, validation, and operation of systems like Veeva Vault Quality and ComplianceWire. You’ll lead both technical and regulatory aspects of IT system management in a hybrid agile/waterfall environment, driving scalable and compliant technology solutions.

Accountabilities:

Job Skills

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