A global pharmaceutical company is looking to hire a Senior Process Quality Excellence Specialist on an initial 12 month contract. Working on global study specific activities within a growing team, you will bring comprehensive Regulatory Intelligence experience and will successfully manage the RIN requirements for Global Clinical Safety Operations.Do not pass up this chance, apply quickly if your experience and skills match what is in the following description.Responsibilities:Become the Regulatory Intelligence coordinator to work with the relevant SMEs for regulatory/guidance requirements to controlled documents.Review regulations and identify which SMEs should be assigned based on the topicAct as a point of contact to confirm that CROs have assessed regulatory and country regulations that may impact their SOPs and clinical studies.Act as Audit Host - work with the Auditing team to host and coordinate with relevant SMEs and functions on any internal Quality Audit.Act as a point of contact and co-ordinator with the auditing team.During the audit, assist the assigned SMEs in responding to queries by the auditees. xjdpvnf Post-audit, work with the SMEs on responses to findings, CAPAs, etc., until the audit is closed.Additional information:Regulatory Intelligence experience requiredQA or Clinical Operations background preferredGCP experience necessaryWillingness to work onsite in Slough 2 days per weekFull-time roleCompetitive hourly rates
Job Title
Senior Process Quality Excellence Specialist