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.
We are seeking an experienced Quality Assurance Specialist to join our team, working directly with our VP of Quality and Regulatory Affairs and other senior level team members.
This position will play a pivotal role in our organisation through some of the following activities:
Providing support to the Quality team so as to maintain GXP compliance for all GMP, GCP, GDP activities.
Ensuring the quality management system is maintained and updated as appropriate. Develop and continuously evaluate quality systems in light of the development of the business and make quality and operational improvements as needed through the management and change control systems, so as to comply with the regulatory needs in EU and US markets and PIC/s standards.
- Providing focus on the management of authorised activities and the accuracy of records.
- Providing quality support and oversight to distribution for API and medicinal products.
- Assisting with NPI and technology transfer and supporting registrations.
- Supporting the preparation, review, and approval of Standard Operating Procedures (SOPs), batch instructions, testing instructions, and records, and other necessary GMP and GDP documents.
- 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
- Following up on any Corrective Actions from internal and external audits and ensuring they are successfully closed out.
- Assisting with the collection for review of 3rd party batch processing, batch packaging, and analytical records of the pharmaceuticals manufactured for the company as required.
The successful candidate will have at least 2-3 years’ work experience in a similar role within the pharmaceutical industry and a third level degree in a science discipline. The successful candidate will enjoy a competitive salary and benefits package in a flexible working environment and will be keen to work and develop in a fast-paced environment in a scaling company. We facilitate a hybrid working schedule where we alternate working remotely with working in our offices in Clonmel, Co. Tipperary. You may also be required to travel from time to time.
Please send your resume to: email@example.com