Quality Specialist
1 week ago
Iksuda Therapeutics is a Biotechnology Company focussed on the development of Antibody Drug Conjugates (ADCs) targeting difficult-to-treat cancers.
We are looking for a QA Specialist to join our Team. A hybrid role, working remotely with visits to the Company's UK and US facilities and vendor sites as appropriate. You will be responsible for supporting the quality management system and assist in oversight of organisations contracted by the company for products manufactured for use in clinical trials in the US, Europe, Canada, Australia.
**Essential Functions and Duties**
- Develop, manage, and maintain appropriate procedures to ensure regulatory compliance
- Support the development and implementation of quality systems including but not limited to:
- _Deviations_
- _CAPA_
- _Change Control_
- _Audits_
- _Customer Complaints_
- _Artwork Management_
- _Supplier Qualification_
- Compilation of CMO batch documentation and performance of a quality review and approval to support of disposition. This includes:
- _Batch records_
- _Failure investigations_
- _Change control documents_
- _Corrective/preventative action documents_
- _Temperature monitoring records_
- _Certificates of Analysis and Certificates of Conformance_
- Monitoring and communication with CMOs to ensure timely receipt of batch documentation.
- Review and approve GMP documents received from CMOs, for example; master batch records, validation documentation, analytical test methods.
- Compilation and reporting of metrics for in market disposition, deviations, change controls, customer complaints and any other metrics to support client and company Management Review meetings.
- Monitor QA/QP activities of contractors and suppliers.
- Participation in regulatory inspections and customer audits as required.
- Support the implementation and maintenance of a document retention process for Company.
- Actively participate in continuous improvement initiatives.
- Identify gaps in quality systems and develop feasible plans for correction.
- Support supplier qualification activities ensuring approved supplier and customer lists are maintained.
- Develop and conduct training for quality and other personnel, as necessary.
- Ensure that quality department personnel are trained to perform their jobs effectively and ensure an efficient operation that is well integrated.
- Maintaining a Quality Risk Management system to ensure that risks are adequately controlled in accordance with current requirements.
- Maintain a thorough knowledge of appropriate standard operating procedures and applicable regulatory requirements and guidance documents.
**Education and Experience**
Minimum 3rd Level Qualification in a science related discipline
**Knowledge, Skills, and Abilities**
- Minimum of 7 years’ experience in GMP, encompassing Quality Management or Compliance role preferably with a virtual organisation
- Understanding of Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs)
- Knowledge of GXP Regulations (ICH, EU GMPs, ISO, FDA etc.)
- Knowledge of electronic document management systems
- High level Computer Literacy and competency - Microsoft Office, Microsoft Project, Excel.
- QP eligible preferable.
**Salary**: £35,000.00-£50,000.00 per year
Schedule:
- Monday to Friday
Work Location: Hybrid remote in Newcastle upon Tyne
Reference ID: IKS/QAS/UK
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