Job Description
Kenny-Whelan (a specialist division of the CPL group) are hiring anotherQuality Systems Specialistto work on contract atJanssen in Little Island Cork HYBRID Role - 3 days onsite ContactJenn Dinan onoremail New vacancy Oct 2024 MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it Quality Systems Specialist Department: Quality Systems (QS) Report to: QS Manager Location: Cork Travel: N/A Hybrid- 3 days onsite -Little Island POSITION SUMMARY: The QS Specialist main responsibilities will be: Supporting the digitalization and automating of quality systems to drive data insights, technology and process innovation Reinvent innovation through integrated quality systems Drive internal/external partner support to deliver e2e customer value, by supporting the implementation of the next generation Quality Systems. The candidate must have a broad knowledge of cGMPs and prior experience of working in HPRA/FDA regulated facility. The candidate must also build customer value through effective collaboration and influencing others, as well as consistently delivering on goals and objectives under minimal direction. The individual will also be responsible for (some of the following): Internal Audit Program Management of the document management system- which can include supporting and advising Documentation Control administration personnel, as required GMP service providers program Managing the nonconformance system and CAPA process; Quality agreement process; Change control process and system Supporting site regulatory inspections where appropriate Supporting the site induction process Metrics and report generation from the quality systems General scope of responsibilities: Reporting to the QS Manager, the person will be responsible for the following: Providing support, direction and training to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met. Partners with other departments to ensure that compliance systems are implemented in an efficient manner. Supports the development and management of GMP compliance systems through the following activities: Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site. Assesses compliance systems on ongoing basis to see opportunities for process improvement. Stays ahead of regulatory compliance trends. Key competencies required: An analytical and critical problem solver Collaborator and a teammate Strategic problem solver Problem solving and attention to detail Results and performance driven Integrity, transparent and objective Customer focused Clear social skills Adaptable and flexible Innovative Inclusive, facilitative style QUALIFICATIONS AND EXPERIENCE: ESSENTIAL: The position of QS Specialist requires a third-level qualification (scientific/ engineering/ IT/ BIS field required) Experience with one or more data analytics techniques and tools such as Tableau, Spotfire, Google Analytics, or PowerBI, and intermediate/advanced Excel will be a distinct advantage. A minimum of 3-5 years experience within the biological and/or pharmaceutical/ medical device industry Knowledgeable of FDA/EMEA regulatory requirements Demonstrated knowledge and application of industry regulations as they apply to systems including those of FDA, HPRA, EMEA and other authorities Desirable: Experience of running project groups or leading teams Skilled in the use of problem solving tools/techniques Experience with systems such as Trackwise and electronic documentation management systems will also be a distinct advantage Key individual contributor competencies: Customer focus is critical Builds strong productive relationships Demonstrates ability to work with teams and individuals Asserts personal ideas and opinions using persuasion to influence others Seeks opportunities to grow and develop professionally Uses best practices to improve business operations Holds oneself accountable for compliant and detailed execution Effectively manages and adapts to change Demonstrates the courage to stand alone on ideas and opinions that differ from others Listens effectively and remains open to others ideas. Works effectively with people that have diverse styles, talents and ideas Maintains the highest standards of ethical behaviour Attention to detail and strong administrative skills MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it All applications will be treated with the strictest of confidence. Contact Jenn Dinan on Skills: Trackwise Change controls Tableau Excel Quality systems QMS Benefits: Paid holiday Parking Staff Discounts