My client are looking for 2 Process Quality Excellence Specialists to support the Process Quality Excellence Lead in developing and maintaining its clinical quality systems/procedures and ensuring quality and compliance risks are appropriately identified and mitigated.
* Support the Process Quality Excellence Lead in GCSO quality and compliance infrastructure development; assist with creation/revision of appropriate quality and compliance policies, SOPs, processes, and best practices as needed
* Work in collaboration with Clinical Development Quality, Patient Safety, Regulatory Affairs, strategic partners, and other stakeholders to ensure compliance with ICH GCP, GLP, PV and relevant local and international regulations and to ensure inspection readiness.
* Participate in Audit and Inspection planning with Clinical Development Quality and Pharmacovigilance Quality Assurance.
* Provide relevant GCP, GLP, and PV guidance and training to GCSO staff for all phases of clinical drug development.
* Support CAPA activity for internal (system) audits and findings from any audits and inspections where findings are raised to the client in conjunction with department managers and subject matter experts. This includes CAPA tracking and monitoring for timely closure.
* Strong pharmaceutical experience, preferably in a global Quality Assurance or a Clinical Development setting
* In depth experience of GCP and GVP, including hands on experience in global GCP audits and/or inspections
* Proven track record of experience in SOP writing essential
* Excellent working knowledge of GCP, GLP, and PV-related requirements, proficiency of regulatory and ICH guidelines
* Detail oriented with Quality Assurance and/or Clinical Quality Management background with analytical and problem-solving skills, including application of root cause analysis
* Project management skills; excellent planning and organizational skills
Please call me or send your resume for immediate feedback