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Job Details

Qualified Person, Solid Oral Dose - Dublin

Company: Just Pharma
Location:
Reference: JBIRQP
Closing Date: 17 Dec 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

A leading global pharmaceutical company is seeking a Qualified Person with solid dosage experience to join their Dublin site.

Requirements:

Just Pharma are recruiting on behalf of a leading global pharmaceutical company, assisting them with their search for a QP at their Dublin site. The Qualified Person is a key member of the Quality Assurance team associated with production of an oral solid dosage product at the company site. In particular, the Qualified Person will assume the role of Qualified Person for the release of the product in accordance with EU Directive 2001/83/EC.

In accordance with business needs, the Qualified Person may assume responsibilities in any other work area of the Quality Department.

As with all site personnel, the Qualified Person is responsible for promoting a culture of Regulatory Compliance and Continuous Improvement within the Quality Department and across the site.

 

RESPONSIBILITIES:

The responsibilities of the Qualified Person include the following:

•             Management of batch disposition and material status control activities for the product, acting as a site Qualified Person.

•             Management of review of Batch Manufacturing Records (BMRs).

•             Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.

•             Co-ordination of the Change Control process associated with production, ensuring controlled implementation of all GMP related changes.

•             QA oversight of routine manufacturing, testing and relating activities to ensure ongoing cGMP compliance.

•             Ensuring effective participation of the Quality Assurance team in production and other site meetings.

•             Implementation of Key Performance Indicators within the Quality Assurance area to align with company and global quality objectives.

•             Participation in the site Internal Audit programme.

•             Participation in the preparation of, and hosting, external cGMP audits, e.g. from Regulatory Authorities and Global Quality.

•             Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions.

•             Taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement. 

 

REQUIREMENTS: 

•             Primary Degree in a scientific discipline

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

•             Minimum of 5 years’ experience in the pharmaceutical industry in a Quality role.

•             Experience of oral solid dosage manufacture. 

 

Key words: quality, qp, qualified person, qa, qc, assurance, control, solid oral dose, manufacturing, production, batch

Apply for this job: Qualified Person, Solid Oral Dose - Dublin

Contact Information:

Address:  Head Office
2nd Floor Albany Chambers, Bridge Road East, Welwyn Garden City, Hertfordshire
AL7 1HL
England
Tel:  0044 1707 830300
Website:  Visit Our Web Site

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