Shorla Oncology develops innovative solutions into effective oncology treatments to improve patients’ lives. The patients’ needs are at the heart of our innovation, ensuring we deliver affordable, accessible medicines and provide a significant clinical impact.
Shorla Oncology has core values of compassion, commitment, innovation, tenacity, and collaboration. At Shorla Oncology we feel passionately about the work that we do and the patients that inspire us. Our focus on oncology gives us the opportunity to truly impact lives. As employees, we are here because we want to be part of a global team, working together to bring hope to underserved patient populations. Our team is smart, collaborative, creative, compassionate, and accomplished. Each day we challenge each other to work on solutions for hope while building a company and culture focused on the future. The patient is at the center of our innovation; our decisions are driven by science while our Shorla Oncology colleagues motivate us to grow and develop every day.
Shorla Oncology has an exciting opportunity for a Quality Assurance Specialist to join our growing team. This position will afford exposure to a broad range of operational learning opportunities and professional development.
Key Responsibilities include:
* Ensure that a quality management system is maintained and updated as appropriate. Develop and continuously evaluate Shorla Oncology quality systems in light of the development of the business, and make quality and operational improvements as needed through the Shorla Oncology management and change control systems, so as to comply with all requirements to satisfy the regulatory needs in the markets in which Shorla Oncology operates, including EU, US, and PIC/s standards.
* Provide quality support and oversight to distribution activities for active pharmaceutical ingredients and medicinal products.
* Assist with new product introduction and technology transfer, and supporting registrations.
* Support the reporting on the effectiveness of the Quality Management System through regular reporting and action-oriented leadership. File the agreed Key Performance Metrics as required to Shorla Oncology management, and monitor performance and help identify improvement and effectiveness activities.
* Respond to Shorla Oncology queries about the state of quality in Shorla Oncology, and contracted organisations, and suppliers.
* Ensure that initial and continuous training programmes are implemented and maintained in Shorla Oncology. Ensure that staff are trained on GXP requirements and Shorla SOPs, so as to ensure competence when making quality decisions. Provide training to staff on site on GMP and GDP, as required and monitor people’s training plans for GMP and GDP compliance.
* Support the preparation, review, and approval of Standard Operating Procedures (SOPs), batch instructions, testing instructions, and records, and other necessary GMP and GDP documents, for activities related to Shorla Oncology operations, and support Shorla Oncology SOPs and policies.
* Preparation of programs for corrective and preventative actions (CAPA) after inspections conducted by regulatory bodies, customers, and other external organizations, and Shorla Oncology internal audits.
* Monitoring of the manufacturing and control conditions at contract manufacturers, testing facilities, customers, and distributors, through audits, or other means, and ensuring the validity of appropriate licences.
* Monitoring of the suppliers of active ingredients, excipients, packaging, and other materials, through audits, or other means, and ensuring the validity of appropriate licences and EU Written Confirmations.
* File supplier audit reports for Shorla Oncology and share results internally as needed.
* Follow up on any Corrective Actions from internal and external audits and ensure they are closed out.
Required Experience and Education:
* Education - University degree in a science.
* Professional experience – not less than 3 years of uninterrupted work experience in the production and/or control or distribution of pharmaceuticals.
* Deputy Responsible Person/GDP experience is advantageous but not essential.
Our offices are based in Clonmel, Co. Tipperary and we facilitate a flexible hybrid working policy where we alternate working from home for the majority of the time with regular visits to the office for in-person interactions with your colleagues. You will also work closely with our commercial team and other colleagues who are based in the USA.
When joining Shorla Oncology you will join a self-motivated and energetic team. Our success depends on our collaboration, camaraderie, teamwork, and team spirit. You will work in a hybrid manner and have opportunities to learn and grow your career. If this sounds like the characteristics of your ideal workplace and you want to work in an exciting growing fast-paced company, then we are a good fit for you.
We offer a competitive salary and an attractive range of benefits including a discretionary bonus scheme, private medical cover, employer pension contributions, generous annual leave, and opportunities for upskilling and career progression.
Shorla Oncology is an equal opportunities employer.
Seniority level
* Associate
Employment type
* Full-time
Job function
* Quality Assurance
* Industries
* Pharmaceutical Manufacturing
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