QA Operations Specialist - Pharma (Try & Hire)
Michael Page Switzerland
Infos sur l'emploi
- Date de publication :02 octobre 2024
- Taux d'activité :100%
- Type de contrat :Temporaire
- Lieu de travail :Genève
We are seeking a highly motivated QA Operations Specialist to join our client's team. This role is critical in ensuring quality standards are met in collaboration with manufacturing and distribution partners. If you have a passion for Quality Assurance, particularly in the pharmaceutical sector, and thrive in a dynamic environment, this is an exciting opportunity to contribute to impactful projects.
Our client is a growing biopharmaceutical company.
Description
We are seeking a highly motivated QA Operations Specialist to join our client's team. This role is critical in ensuring quality standards are met in collaboration with manufacturing and distribution partners.
Key Responsibilities:
- Coordinate and oversee QA Operations activities with external manufacturing and distribution partners.
- Maintain accurate tracking and processing of the company's QA operations.
- Ensure thorough and compliant documentation of QA activities.
- Support the Responsible Person (RP) in managing GxP-related projects.
Main Tasks:
- Manage and resolve quality complaints.
- Handle change control processes with both partners and internal teams.
- Oversee and manage deviations from partners and intra-company processes.
- Prepare and verify documentation for product release and shipment.
- Ensure proper documentation, record-keeping, and archiving of quality records.
- Coordinate Quality Technical Agreements (QTAs) and assist in audit processes.
- Compile monthly Quality KPIs for management reporting.
- Assist in the development and implementation of GxP training programs.
- Contribute to the continuous improvement of the Quality Management System (QMS).
- Provide support for additional quality-related projects as needed.
Profile
- Degree in Pharmacy, or a related Master's in pharmaceutical sciences (or equivalent).
- At least 3 years of experience in QA Operations within the pharmaceutical industry.
- Proven experience working with external partners and QA systems (a plus).
- Knowledge of biological drugs or sterile products. Experience with vaccines is an advantage.
- Fluency in English, both written and spoken.
- Strong understanding of Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs).
Job Offer
- Be part of a fast-paced, innovative environment.
- Work alongside experienced professionals and external partners in a hybrid setup.
Contact
Michael Page Switzerland