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Job Details

Quality Manager/Responsible Person

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LCD9562
Closing Date: 16 Dec 17
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

Our client, a global pharmaceutical company, are currently recruiting for a Quality Manager/Responsible Person.

Requirements:


Our client, a global pharmaceutical company, are currently recruiting for a Quality Manager/Responsible Person.

Purpose
• This is a new role in the company. This person will be responsible for setting up the local quality function and the transfer of Quality responsibilities from UK to Irish office in 2018.
• To fulfil the responsibilities of the RP as authorised by being a named RP on the company wholesalers license
• To ensure GDP compliance and maintain a compliant Quality Management System.
• To lead Quality activities at Irish office including management of those completed by non-Quality roles.
• To support other departments in maintaining internal & external quality standards for distribution activities.
• To set strategic direction and policies for the Quality in line with Corporate policies and guidelines, in liaison within the affiliate and the PT/PD organisation
• To represent the Quality team at Local and Global levels
 

Key Tasks
• Personal responsibility to ensure all responsibilities and duties as described in GDP Guideline 2013/C 343/01 are met, as follows:
o Ensure a GDP QMS is implemented and maintained.
o Ensure that records are accurate and of a suitable quality.
o Ensure that initial and continuous training programmes are in place and maintained.
o Coordinate any recall activities in a prompt manner.
o Ensure customer complaints are dealt with effectively.
o Ensure all suppliers and customers are approved.
o Approval of subcontracted activities.
o Ensure self-inspections are performed at appropriate regular intervals following a pre-arranged programme and necessary CAPAs are put in place.
o Ensure appropriate records are kept of delegated duties.
o Decide on the final disposition of returned, rejected, recalled or falsified product.
o Approve returns to saleable stock.
o Ensure that any additional requirements imposed on certain products by national law are adhered to.
• Manage and support corporate and regulatory audits as required.
• Other tasks as described in the job description.
 

Requirements
·    Thorough knowledge of applicable Irish statutory instruments and EU Directives
·    A degree in pharmacy is desirable
·    5-10 years experience in a quality role in the pharmaceutical industry
·    A minimum of 2 years experience as a Responsible Person (RP)

If you are interested in applying for this role please call Linda on +353 1 2784671 or email ldunne@thornshaw.com 
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com

 

Apply for this job: Quality Manager/Responsible Person

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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