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Quality assurance expert

Cork
beBeeCompliance
Posted: 26 August
Offer description

Pharma Quality Assurance Specialist

A key position in our organization is available to oversee and improve the quality management system for pharmaceutical products.

Key Responsibilities:

* Ensure regulatory compliance and implement processes that meet good manufacturing practices (GMP) standards.
* Manage product disposition, review batch records, and ensure market authorization compliance.
* Represent the company during regulatory inspections and support inspection activities.
* Oversee team members reviewing and approving non-conformances, CAPA, change controls, and complaints.
* Develop and implement quality strategies to enhance processes and maintain compliance.

Requirements:

* Minimum 1 year of experience in GMP sterile manufacturing.
* Relevant third-level qualification in science or equivalent.
* Eligibility to act as a European Qualified Person (QP) for certifying products in compliance with EU regulations.
* Primarily onsite role with some flexibility.

Benefits:

* Opportunity to work in a dynamic pharma environment.
* Contribute to developing and implementing quality strategies.
* Collaborate with a talented team to drive process improvements and maintain compliance.

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