Kenny-Whelan (a specialist division of the CPL group) are hiring a Quality executivefor our Global Biopharma client in Barnahely ,Ringaskiddy Cork
Contact Jenn Dinan on 0860466583 or email jdinan@kenny-whelan.ie
The JSI Quality Executive/Deputy Responsible Person is responsible for carrying out tasks and projects related to management of Quality Assurance or Quality System activities for Legal Entity JSI as required by Good Manufacturing Practice (GMP) and Good Distribution Practices (GDP).
General Scope of Responsibilities The Quality Executive/Deputy Responsible Person is responsible for supporting the maintenance of the Quality Management System for JSI Legal Entities. These activities include change control, non-conformance investigation, supporting internal/corporate and health authority inspections, customer and supplier qualification, supply chain projects, compilation of metrics and document management.
Key Role Activities: • Prepare, update and approve procedures in accordance with GMP/GDP and company 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.
In addition, the role profile of the Quality Executive/Deputy Responsible Person is to act in accordance with the requirements detailed below in the absence of the RP, ensuring to keep appropriate records of any delegated duties
• Maintains the Wholesale Distribution Authorisation, ensuring compliance with the general conditions detailed, in line with European and local regulations. • To ensure compliance with the requirements of Good Distribution Practice (EU GDP). • To ensure that all aspects of the quality system are implemented and maintained. • Ensure that the quality, safety and traceability of medicinal products are maintained within the supply chain. • To ensure appropriate competence and experience as well as knowledge of and training in GDP. • To ensure initial and continuous training programs are implemented and maintained. • To have oversight of approval for return to saleable stock any medicinal products returned by a customer. • RP should have oversight of all documentation practices required. • Coordinates and performs recall operations for medicinal products. • To be involved in any decision to quarantine or depose of returned, rejected, recalled or falsified medicinal products. • To approve new customers and suppliers and periodic review of existing customers and suppliers. • Management of customer complaints, ensuring they are dealt with effectively • To escalate any complaints, reported defects, reported falsified medicinal product • The approval of sub-contracted activities which may impact on GDP. • To notify HPRA of any change of RP by way of variation to the Licence. • To manage self-inspections, ensuring that they are performed at regular intervals following a prearranged programme and necessary corrective actions are put in place; • To ensure that any additional requirements imposed on certain products by national law are adhered to
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 0860466583
