Kenny-Whelan (a specialist division of the CPL group) are hiring a Quality Executive for our Global Pharmaceutical client
The Quality Executive has Quality oversight of the wholesaling of API's and Medicinal Products for two Legal Entities.
Must be RP/DRP Qualified
The person can be based in Dublin or Cork and will have a desk in either location. Hybrid role
The expectation would be 1-2 days a week onsite with flexibility either way
Contact Jenn Dinan on 0214665408 and email CV's to [email protected] or the link below
Quality Executive
Position Summary:
The Quality Executive supports the Quality oversight of the wholesaling of API's and
Medicinal Products for two Legal Entities, Janssen Pharmaceutical Sciences (JPS) and Janssen Sciences Ireland UC (JSI) and is responsible for carrying out tasks and projects related to management of Quality Assurance or Quality System activities as required by Good Manufacturing Practice (GMP) and Good Distribution Practices (GDP).
General Scope of Responsibilities
The Quality Executive for Legal Entities is responsible for supporting the maintenance of the Quality Management System for JSI and JPS Legal Entities.
These activities include change control, non-conformance investigation, supporting internal/corporate and health authority inspections, customer and supplier qualification, compilation of metrics and document management.
Key Role Activities:
• Prepare and update and approve procedures in accordance with GMP/GDP and J&J requirements
• Manage all documents in accordance with records management
• Assist in the implementation and update of internal or external standards
• Identify and Log Quality Issues, perform impact assessments and lead investigations
• Collaborate effectively with various internal and external partners
• Ensure appropriate management of non-conformances related to GMP and GDP, internal and external change controls and CPAs.
• Support the Quality Manager with monitoring and oversight of outsourced activities.
• Perform allocated internal audits as required
• Support and participate in local initiatives or projects to increase compliance and reduce costs/non-conformance.
• Provide the necessary input to the Quality Manager for the bi-annual management review of the Legal Entities.
• Support the process for intake of medicinal queries and complaints, ensuring timely case processing.
• Ensure that any requirements of the Wholesale Distribution Authorisation are fulfilled.
• Support the compilation of customer and supplier documentation to aid the Bona Fide process.
• Support the RP with maintenance of the product and financial flows.
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Key Skills and Competencies required:
• Excellent interpersonal skills
• Ability to operate as part of a team is critical.
• Customer focus
• Innovative
• Excellent communication skills both written and verbal
• Attention to detail
• Good problem-solving skills
• Results and performance driven
• Adaptable and flexible
Decision making
Qualifications and Experience:
Essential:
• Bachelor’s Degree in a Scientific/Technical discipline required
• A minimum of 5-8 years’ experience in a Quality or compliance role within the Pharmaceutical industry, most specifically in relation to GMP and GDP.
• Formal certified GDP Training on Good Distribution Practice of Medicinal Products for Human Use
• Up to date knowledge of relevant pharmaceutical legislation and GMP/GDP. Ability to apply GMP and GDP regulations and international guidelines to all aspects of the position.
• Demonstrated knowledge and application of industry regulations as they apply to quality, including those of HPRA, EMEA, FDA and other authorities.
DESIRABLE:
• Previous experience working as a Deputy Responsible Person
• Experience in auditing of external suppliers, contractors and vendors.
All application will be treated with the strictest of confidence.
Contact Jenn Dinan on 0214665408 or email [email protected] or the link below