Quality Compliance Specialist

Dublin North  ‐ Onsite
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Description

I am currently recruiting for a Quality Operations Compliance Specialist for a global pharmaceutical company based in North Dublin. The role is a 12 month fixed term contract.

The position will be responsible for providing quality and compliance support to the A & I Quality Operations group in External Manufacturing Quality. This role will be involved in preparing and negotiating Quality Agreements with Contract Manufacturers (CMO's) as well as tracking the receipt of annual quality product reviews from contract manufacturers and managing the quality compliance to the APQR procedure.

The position will be responsible for the co-ordination/tracking of the annual CMO Risk Assessment process, ensuring timely completion of the assessments and managing associated metrics as well as supporting Compliance Plans for CMOs based on the annual risk assessment and any other interim triggers, and monitor their implementation.

In addition they will provide support for the A&I Quality Operations metrics programs in relation to CMO performance and act as API rep for compliance related topics on cross functional teams.

As External Manufacturing is a virtual organisation with stakeholders within and outside the company, the ideal candidate will demonstrate excellent interpersonal, communication and presentation skills, strong analytical and problem solving skills. Applicants must also possess the ability to work well both on their own initiative and also within a team environment.

Requirements:

*A BSc in a scientific discipline such as Chemistry or Microbiology.

*A minimum of five years experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, or Regulatory areas, or a position within a Health Authority Agency.

*The ideal candidate will have extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations.

*An in-depth knowledge of cGMP regulations for the pharmaceutical industry, specifically FDA and/or EMA.

* An ability to assess the right balance between business targets and scientific and quality decisions.

If you have the relevant skill set and experience please contact me Anna Mooney or reply below with an up to date CV.
Start date
09/2015
From
Real Staffing
Published at
17.10.2015
Project ID:
1002304
Contract type
Permanent
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