Description
A Bio/Pharma company not far from London is looking for a Process Quality Excellence Specialist to join their team. If you are interested and want to know more details, send and application and we'll be in touch!Responsibilities:
- 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.
- Represent or ensure GCSO representation and preparation during audits/inspections (on-site at the client by internal and external parties)
- Attend improvement initiatives to improve quality and compliance processes and effectiveness in collaboration with stakeholders
- Stay abreast with GCP, GLP, regulatory, and industry trends. Share key information gathered via professional associations and conferences (upcoming regulations, best practices) within the GCSO Practice, Global Regulatory Affairs, and Clinical Quality Assurance.
- Provide relevant GCP, GLP, and PV guidance and training to GCSO staff for all phases of clinical drug development.
- Partner with colleagues/others to (proactively) identify and mitigate compliance risks, resolve potential compliance observations and escalate critical compliance risks to Clinical Quality Management Lead.
- Represent GCSO in clinical team meetings and discussions as needed
Requirements:
- 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
Technical knowledge - 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
- Ability to prioritize based upon the compliance and patient safety risk
- Ability to proactively identify critical issues, propose mitigation strategies, and escalate issues, when necessary, to senior management
- Ability to work effectively in a fast-paced environment
- Ability to analyse and reconcile moderate-to-complex compliance issues independently and in a group setting
- Good analytical and investigation skills
- Accountable for the compliance of all activities in scope of responsibilities
Michael Bailey International is acting as an Employment Business in relation to this vacancy.