Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.
We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued expansion.
To support our growth, we are seeking a confident and proactive Quality Release Specialist to join us, working directly with the Quality Specialists and Quality Manager to support the business in relation to all Quality matters detailed below.
Requirements
Effectively manage the operational tasks within the Quality Management System (QMS), including Quality Business Partnering with other departments to support the investigation, review and closure of records within the Clinigen electronic QMS. Create, review and approve relevant standard operating procedures, work instructions and forms. Maintain Clinigen paper and electronic records of Quality documentation, in line with Good Documentation Practise and Clinigen procedures. Participate in and support internal, external and Regulatory audits and inspections. This includes delivery of audit corrective and preventative actions. Assist in providing training to members of staff on relevant components of the QMS or procedures. Contribute to continual improvement by formulating reports, trending and data analysis. Identify and support the implementation of process improvement opportunities, collaborating with the business areas to form a strong and effective operational excellence team dynamic. Benefits
27 days holiday plus 8 bank holidays. Pension contributions 4.5% matched. Life assurance 4 x annual salary. Flexible Benefits Platform with £25/month Company contribution. Annual salary review. Independent financial advice service. Enhanced Employee Assistance Programme. Shopping discounts with retailers. Long service awards. Recognition scheme & employee of the year awards.
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We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued expansion.
To support our growth, we are seeking a confident and proactive Quality Release Specialist to join us, working directly with the Quality Specialists and Quality Manager to support the business in relation to all Quality matters detailed below.
Requirements
Effectively manage the operational tasks within the Quality Management System (QMS), including Quality Business Partnering with other departments to support the investigation, review and closure of records within the Clinigen electronic QMS. Create, review and approve relevant standard operating procedures, work instructions and forms. Maintain Clinigen paper and electronic records of Quality documentation, in line with Good Documentation Practise and Clinigen procedures. Participate in and support internal, external and Regulatory audits and inspections. This includes delivery of audit corrective and preventative actions. Assist in providing training to members of staff on relevant components of the QMS or procedures. Contribute to continual improvement by formulating reports, trending and data analysis. Identify and support the implementation of process improvement opportunities, collaborating with the business areas to form a strong and effective operational excellence team dynamic. Benefits
27 days holiday plus 8 bank holidays. Pension contributions 4.5% matched. Life assurance 4 x annual salary. Flexible Benefits Platform with £25/month Company contribution. Annual salary review. Independent financial advice service. Enhanced Employee Assistance Programme. Shopping discounts with retailers. Long service awards. Recognition scheme & employee of the year awards.
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