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Do you have strong experience in CSV auditing, gained in a regulated Pharmaceutical, Clinical or CTS setting? Do you have RTSM / IRT experience, gained in either sponsor or vendor environments? We are looking for a skilled Auditor who has expertise in planning, conducting and managing audits and is able to draw upon a range of skills to help the development of a leading RTSM software provider.
This is a permanent role for a Senior Quality Auditor, with an excellent salary and benefits (to discuss on application). Given that you can work largely remotely, you can be based in either East Coast US, UK, or Mainland Europe, though you must be willing to travel if required.
You will join an award-winning global leader in randomization and trial supply management (RTSM) for the global life sciences industry. They have built a culture that embraces innovation and the spirit of experimentation in order to fully explore and harness the possibilities of their technology, which is fully customisable to meet the needs of complex clinical trials.
The Role
You will be responsible for planning, conducting, and reporting of internal audits according to the quarterly audit schedule or as requested by the Quality Audit Lead or Quality Management. You will carry out internal audits of the company’s products and service offerings such as Product Development Life Cycle, Study Development Life Cycle, Training, Client Studies, Data audits, products releases and change control.
You will provide guidance for resolving issues and work with the Computer System Validation (CSV) group to ensure resolutions include maintaining the validation of products and studies.
You will conduct lessons learned with auditees after audit completing, audit regulations, procedures, and industry best practices, prepare audits reports and certificates.
You will monitor and analyse results of internal audits for trends, participate in continuous improvement of the company’s procedures and overall quality system and work with Quality Audit Lead for audit reporting and escalations to Quality Management. You would mentor junior auditors and assist in hosting client audits and participate in all regulatory inspections.
Experience
You have a Bachelor’s degree in a life sciences or information technology degree or equivalent auditing experience. You would ideally have minimum 5 years’ professional experience as an Auditor in a regulated environment and 3 years’ experience auditing Computer Systems Validation. You must have competitive skills in audit planning, audit conduct and audit management. RTMS (Randomization and Trial Supply Management)/IRT/IVRS/IXRS platform experience is desired but not essential. If you are member of the Society of Quality Assurance (SQA) or Regulatory Affairs Professionals (RAPS) certification would be desired but not essential.
Expired
- Location: Nottingham
- Salary: Competitive Salary plus benefits
- Job Type:Permanent
Posted over 2 years ago
- Sector: Quality
- Contact: Adrienn Prezenszki
- Contact Email: adrienn.prezenszki@nextphaserecruitment.com
- Contact Phone: 01403 216216
- Start Date: 2021-11-15
- Job Ref: V-47100
This is a permanent role for a Senior Quality Auditor, with an excellent salary and benefits (to discuss on application). Given that you can work largely remotely, you can be based in either East Coast US, UK, or Mainland Europe, though you must be willing to travel if required.
You will join an award-winning global leader in randomization and trial supply management (RTSM) for the global life sciences industry. They have built a culture that embraces innovation and the spirit of experimentation in order to fully explore and harness the possibilities of their technology, which is fully customisable to meet the needs of complex clinical trials.
The Role
You will be responsible for planning, conducting, and reporting of internal audits according to the quarterly audit schedule or as requested by the Quality Audit Lead or Quality Management. You will carry out internal audits of the company’s products and service offerings such as Product Development Life Cycle, Study Development Life Cycle, Training, Client Studies, Data audits, products releases and change control.
You will provide guidance for resolving issues and work with the Computer System Validation (CSV) group to ensure resolutions include maintaining the validation of products and studies.
You will conduct lessons learned with auditees after audit completing, audit regulations, procedures, and industry best practices, prepare audits reports and certificates.
You will monitor and analyse results of internal audits for trends, participate in continuous improvement of the company’s procedures and overall quality system and work with Quality Audit Lead for audit reporting and escalations to Quality Management. You would mentor junior auditors and assist in hosting client audits and participate in all regulatory inspections.
Experience
You have a Bachelor’s degree in a life sciences or information technology degree or equivalent auditing experience. You would ideally have minimum 5 years’ professional experience as an Auditor in a regulated environment and 3 years’ experience auditing Computer Systems Validation. You must have competitive skills in audit planning, audit conduct and audit management. RTMS (Randomization and Trial Supply Management)/IRT/IVRS/IXRS platform experience is desired but not essential. If you are member of the Society of Quality Assurance (SQA) or Regulatory Affairs Professionals (RAPS) certification would be desired but not essential.