Job Details: QA Regulatory Affairs Specialist


jobContax

104 Upper Drumcondra Road,
Dublin 9
http://www.jobcontax.com
Please contact: Karen
JobContax was founded in 2001 by Karen McHugh, an engineer passionate about offering quality opportunities to the jobseeker and an intelligent service to the client. Jobcontax has successfully operated as a global market leader and technical specialist within the following sectors:

Construction and Infrastructure

Engineering and Design

Mining - Oil and Gas

Biotechnology and Pharmaceutical

During the past 10 years Jobcontax have expanded our international network across 5 continents. In 2005 we began recruiting for the Australian market and in 2011 we set up our first strategic partnership in WA. In March 2010, we opened our Shanghai office to strengthen our presence in the rapidly expanding Chinese market for highly skilled professionals. JobContax has a strong presence in Canada, Europe and the Middle East.

Jobcontax has built its reputation on its consultative approach. Our understanding of the industries and the businesses and individuals within these industries enables us to facilitate the perfect match between client and jobseeker. From global multinationals to SME?, Jobcontax has become the trusted recruitment partner.
QA Regulatory Affairs Specialist
Job Description




Overall responsibility for the area of Regulatory Affairs, including but not limited to the following:

Preparing documents and samples for external Regulatory Affairs departments. Communication with external stakeholders including Global Regulatory Affairs, Affiliates and Competent Authorities is an integral part of this role.

Tracking of variations and global change controls and ensuring that changes are implemented only when approved.

Relevant information must be shared with affected stake-holders .

Maintaining of Product & Shelf Life Specifications.

Ensuring compliance of all activities with GMP regulations.

With regard to Variation regulations ? be able to interpret and advise on the variation types.

Ensuring that the dossiers submitted to the various regulatory authorities reflect actual activities in the plant and are compliant.

Preparation of the annual report to FDA and the variation report & assessment for periodic quality review.

Maintenance of SOPs, Site Master File and manufacturing authorization.

Excellent communication skills are essential to this role.

The successful candidate must have proven ability to multi-task and to work under pressure, often having to respond to requests in a very short time period.

Attention to detail and strong technical skills with ability to interpret data are essential to this role.

The successful candidate must have a good understanding of both Analytical and Production processes.




Requirements:



It is imperative that the successful candidate has excellent communication skills, report writing and reviewing skills, good attention to detail, and proven initiative.

The position requires a third level qualification in a relevant scientific discipline.




Package:

Contract rate - Negotiable based on experience

Minimum Contract duration: 6 months



Job Description




Overall responsibility for the area of Regulatory Affairs, including but not limited to the following:

Preparing documents and samples for external Regulatory Affairs departments. Communication with external stakeholders including Global Regulatory Affairs, Affiliates and Competent Authorities is an integral part of this role.

Tracking of variations and global change controls and ensuring that changes are implemented only when approved.

Relevant information must be shared with affected stake-holders .

Maintaining of Product & Shelf Life Specifications.

Ensuring compliance of all activities with GMP regulations.

With regard to Variation regulations ? be able to interpret and advise on the variation types.

Ensuring that the dossiers submitted to the various regulatory authorities reflect actual activities in the plant and are compliant.

Preparation of the annual report to FDA and the variation report & assessment for periodic quality review.

Maintenance of SOPs, Site Master File and manufacturing authorization.

Excellent communication skills are essential to this role.

The successful candidate must have proven ability to multi-task and to work under pressure, often having to respond to requests in a very short time period.

Attention to detail and strong technical skills with ability to interpret data are essential to this role.

The successful candidate must have a good understanding of both Analytical and Production processes.




Requirements:



It is imperative that the successful candidate has excellent communication skills, report writing and reviewing skills, good attention to detail, and proven initiative.

The position requires a third level qualification in a relevant scientific discipline.




Package:

Contract rate - Negotiable based on experience

Minimum Contract duration: 6 months





We need : English (Good)

Type: Permanent
Payment: package
Category: Pharmaceutical

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