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Responsible Person  – Part Time (RP) - Ireland  

Company managed [?] Still accepting applications
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Posted on : 19 October 2017

Project Description

This is an exciting time at Acorn Regulatory. We are working on some of the most ambitious and groundbreaking medical projects in the sector and we are working with clients all over the world. Now, we are recruiting for three positions.  We are seeking to recruit a Quality Specialist, a part-time Quality  Specialist and a part-time Responsible Person (RP).

We have a very positive working environment and we are able to tailor roles to suit the lifestyle of the individual.  Our team of 12 full time consultants in our Clonmel, Co. Tipperary offices are supplemented by a team of consultants working on client sites around the world.

We offer industry leading packages to the right candidates.  We have a comprehensive flexible benefits package and  company pension scheme that allows our colleagues to choose the benefits that best suit their lifestyles.  Acorn Regulatory also operates a flexi-time policy.

The new roles are a mix of both full time and part-time roles.  If you would like to discuss these roles further or receive a detailed spec then please contact Brian Cleary at Acorn Regulatory on 00353 52 61 76 706 or email: info@acornregulatory.com

Quality Specialist (Part-Time):

Job Description:

Key Responsibilities:
Manage and maintain the company’s quality management system (QMS).
Develop, manage, maintain and analyse Key Performance Indicators (KPI’s) and escalates to management as appropriate.
Ensure compliance to appropriate ISO standards (ISO 9001:2015)
Ensuring compliance to the Internal Audit program and conduct internal audits.
Analysis of QMS performance and communicate results via Quality Review Meetings and Management Review Meetings.
Review and approve documents internally and for external clients.
Participates or serves as lead Quality Representative on process improvement initiatives.
Collaborates with cross functional partners to identify and implement improvements.
Education and additional requirements:
• B.Sc. in Science related discipline as minimum.
• More than 3 years’ experience in the area of Quality Assurance.
• Experience and knowledge of ISO 9001 standard, GMP and GDP Guidelines
• Relevant auditing qualification, i.e. Lead Auditor
• Knowledge of US and EU Regulations (ICH, EU GMPs, GDPs, ISO, etc.)
• Knowledge of electronic data systems.
• Demonstrated proficiency in the use Microsoft Office software (Word, Excel, PowerPoint, and Access); Project and Visio.

 

Responsible Person (RP) (Part-Time):

Job Description:

Key responsibilities:
Ensuring that a Quality Management System is implemented and maintained;
Management of authorised activities and the accuracy and quality of records;
Ensure that initial and continuous training programmes are implemented and maintained;
Coordinate and promptly performing any recall operations for medicinal products;
Ensure that relevant customer complaints are dealt with effectively;
Ensuring that appropriate provisions are implemented for suppliers and customers
Approve any subcontracted activities which may impact on GDP;
Self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
Keep appropriate records of any delegated duties;
Final disposition of returned, rejected, recalled or falsified products;
Approve any returns to saleable stock;
Ensure that any additional requirements imposed on certain products by International/National law are adhered to.
Education/Experience/Training Required:

• B.Sc. in Science related discipline.
• More than 5 years’ experience in this or similar role
• Comprehensive knowledge and appropriate qualification in the role of RP and experience in GDP processes and procedures.
• Able to communicate effectively with other departments, management and operational personnel.
• Customer/Stakeholder focused (understands impact of daily work to compliance and overall business).

Quality Specialist (Full -Time):

Job Description:

Key responsibilities:
Support the client in obtaining and maintaining their WDA licence by acting as the Responsible Person (RP).
Manage and maintain the company’s existing quality management system (QMS).
Develop, manage, maintain and analyse Key Performance Indicators (KPI’s).
Compliance to appropriate ISO standards (ISO 9001:2015)
Compliance and knowledge to the Internal Audit program and conduct internal audits.
Review and approve documents internally and for external clients as part of RP or Quality role.
Participates or serves as lead Quality Representative on process improvement initiatives.

Education/Experience/Training Required:

• B.Sc. in Science related discipline.
• More than 5 years’ experience in this or similar role.
• Comprehensive knowledge and appropriate qualification in the role of RP and experience in GDP processes and procedures.
• Experience and knowledge of ISO 9001 standard, GMP and GDP Guidelines.
• Relevant auditing qualification, i.e. Lead Auditor.
• Experience and Knowledge of US and EU Regulations (ICH, EU GMPs, GDPs, ISO, etc.).
• Demonstrate proficiency in the use Microsoft Office software (Word, Excel, PowerPoint, and Access); Project and Visio.

 

The new roles are a mix of both full time and part-time roles.  If you would like to discuss these roles further or receive a detailed spec then please contact Brian Cleary at Acorn Regulatory on 00353 52 61 76 706 or email: info@acornregulatory.com