The role of the Senior GCP Auditor is to provide Quality Assurance (‘QA’) auditing services to external clients and to conduct contracted activities in accordance with contractual requirements, regulations, guidelines and Standard Operating Procedures (‘SOPs’).
This is a permanent role.
Major Responsibilities
Client / project-related activities :
* Plan, conduct, report and follow up contracted audits within agreed budget and timelines
* Manage the fulfilment of assigned contracted activities; identify and escalate any potential out-of-scope activities
* Keep company Senior Director of QA / project manager, and the client where applicable, informed of the progress of all assigned contracted activities and any issues that may arise by providing regular updates and maintaining effective communication
* Foster and maintain good, professional working relationships with clients and identify new business opportunities
General :
* Keep abreast of current industry practices, applicable quality legislation and industry news
* Maintain a high level of organisation and effective prioritisation of workload
* Ensure the security of confidential material at all times, and that Non-Disclosure Agreements (‘NDAs’) are in place before the release of any confidential information to third parties
* Perform administrative tasks effectively and in a timely fashion
* Account for time, including time spent on client activities, in accordance with company requirements
* Actively contribute to the ongoing development and process improvement
* Report any identified internal quality / compliance issues
Skills Required
* Thorough knowledge of applicable GxP(s) and / or other applicable regulatory requirements
* Excellent attention to detail, organisation and prioritisation skills
* Strong interpersonal, verbal and written skills, and ability to communicate confidently at all levels
* Self-motivation and ability to function independently and within a team
* Ability to function calmly under pressure
* Practical and enquiring approach to problem solving
* Working knowledge of Microsoft Word, Excel and PowerPoint
* Fluency in English (reading, written, spoken)
Education or Equivalent Experience
* Experience of working in some capacity within an applicable GxP area
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