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Bilingual Qualified Person – English/Spanish

12/07/2018

Job Description

Qualified Person (QP)

Fluent in English & Spanish — Dublin

We are seeking an experienced Qualified Person for a role in an established Pharmaceutical company. This is a bilingual role with the requirement being English & Spanish. The QP will Responsible for ensuring that the process for the manufacture of the client’s products are in compliance with CGMP and the associated regulatory requirements.

Responsibilities:

Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations.

Assisting in, and facilitating investigations, ensuring effective Root Cause Analysis and CAPAs.

Provision of advice on all aspects of Regulatory GMP practices and systems.

Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements.

Assist in the proactive evaluation of site compliance against emerging regulatory trends.

Requirements

Fluency in oral and written English and Spanish

Primary degree in a relevant Scientific discipline

Must meet the educational requirements of a Qualified Person as per EU Directive 2001/83/EC and 2001/20/EC

Experience in the EU regulated pharmaceutical environment;

Demonstrated knowledge of global health authority regulations and quality and compliance requirements with the ability to effectively communicate these requirements.

Knowledgeable in Industry Best Practices for quality and compliance related topics.

Strong collaboration and cross-functional skills to drive continuous improvement and promote knowledge sharing and implementation of best practices.

Strong verbal and written communication skills in both english & spanish

Project management skills.

Demonstrated ability to make and act on decisions while balancing speed, quality and risk.

For a full job spec please call Shirley on 086-7831786 or email Shirley.kiernan@pharmaforce.ie

To apply for this position follow the link : Pharmaforce 

For assistance on arrival in English, Spanish, Italian and French contact our colleagues at EazyCity www.eazycity.com

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