Vacancies: Responsible Person (RP) & Quality Specialist

As part of our ongoing growth, we are now recruiting for a further two positions.  The Responsible Person (RP) and Quality Specialist roles are part of our expansion plans that were recently reported on by industry website MedTech Engine.  

We have a diverse team of specialists who work with clients on issues such as clinical trials, advertising compliance, licensing new products for international markets and much more.  Our practice areas include Pharmaceutical, Medical Device, Pharmacovigilance and Clinical Trials. Furthermore, we are constantly expanding as clients seek us our services to help them bring new products to market.

Since 2002 we have fostered a fantastic team spirit at the company and we are actively seeking team players.  We now have a growing global client list and this presents countless opportunities for dynamic and committed individuals to develop their career.

Responsible Person (RP) (Part-Time)

Job Description:

Key responsibilities

Ensuring that a Quality Management System is implemented and maintained for external client;

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 (Part -Time)

Job Description:

Key responsibilities:

Support to the existing Quality team and maintain the company’s quality management system (QMS).

Develop, manage, maintain and analyse Key Performance Indicators (KPI’s).

Compliance and knowledge to the Internal Audit program and conduct internal audits.

Review and approve of internal quality documents.Support to the existing Quality team with external client activities.

Establish and maintain a Quality Management System (QMS) for external GDP clients.

Participates or serves as 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.
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.).
Able to communicate effectively with other departments, management and operational personnel

Customer/Stakeholder focused (understands impact of daily work to compliance and overall business).

 

We offer competitive salaries, a comprehensive benefits package including a company pension scheme and much more.  If you would like to talk to us today about how you could progress your career with Acorn Regulatory then get in touch.  You can call Brian Cleary at Acorn Regulatory at 00353 52 61 76706 or email: brian.cleary@acornregulatory.com

Our other open vacancies are detailed here: