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Improving Quality
Mariem Sarghini
,
London, United Kingdom
Experience
Other titles
Skills
I'm offering
A Quality Assurance ('QA') professional with 16 years' experience in QA and 11 years' experience as a Good Clinical Practice ('GCP') Pharmacovigilance (GVP) auditor with pharmaceutical companies, Contract Research Organizations ('CROs') and Pharmacovigilance service provider. With over 5 years QA Management experience across the GXPs.
Markets
United Kingdom
Language
English
Fluently
Ready for
Larger project
Ongoing relation / part-time
Available
My experience
2019 - ?
job
Director Quality Assurance
Bionical Emas.
• Commercialization and business development activities for QA department, attending bid defense meetings, global conferences identifying new business leads for the department.
• Conduct of Internal and supplier Audits, including for cause audits across the GXPs
• Annual risk assessments across the business function to identify the audits to be scheduled in across a 5-year period.
• Management of global audit schedule and ensuring all audits are completed on time and within budget.
• Management of GxP audit consultants
• Gap Analysis of systems, bridging gaps by creation of procedures and training workshops.
• Provision of QA consultation services to both external and internal stakeholders.
• Conduct of Internal and supplier Audits, including for cause audits across the GXPs
• Annual risk assessments across the business function to identify the audits to be scheduled in across a 5-year period.
• Management of global audit schedule and ensuring all audits are completed on time and within budget.
• Management of GxP audit consultants
• Gap Analysis of systems, bridging gaps by creation of procedures and training workshops.
• Provision of QA consultation services to both external and internal stakeholders.
Business development, Training, Budget, Audit, Management, QA, Workshops, Quality Assurance, Development, Audit
2016 - 2018
job
Senior Manager Quality Assurance
APCER Life Science.
• Setting up training programs for audit training
• SOP creation, development implementation and training
• Gap analysis
• Hosting client audits and regulatory inspections
• CAPA Management
• Management and delivery of the global audit program
• Line manager to 5 auditors
• CAPA metric development
• Awareness of current PV and GCP regulations
• Driving due diligence activities for all vendors/sub-contractors used
• Acting as Client Liaison and main point of contact for any quality related issues
• Reviewing and approving deviations and assessing impact to the global PV system
• Leading the quality assurance department as being a department of excellence and a 'go to' place for all quality related issues.
• Commercialization of the Quality Assurance department
• Risk assessing new clients, projects, audits and vendors.
• SOP creation, development implementation and training
• Gap analysis
• Hosting client audits and regulatory inspections
• CAPA Management
• Management and delivery of the global audit program
• Line manager to 5 auditors
• CAPA metric development
• Awareness of current PV and GCP regulations
• Driving due diligence activities for all vendors/sub-contractors used
• Acting as Client Liaison and main point of contact for any quality related issues
• Reviewing and approving deviations and assessing impact to the global PV system
• Leading the quality assurance department as being a department of excellence and a 'go to' place for all quality related issues.
• Commercialization of the Quality Assurance department
• Risk assessing new clients, projects, audits and vendors.
Training, Audit, Management, Due Diligence, Hosting, Quality Assurance, Implementation, Development, Regulatory, Audit, UP, Manager, Go
2015 - 2016
temp
Quality Assurance Manager
Human Immunology Laboratory.
• Setting up and establishing robust quality management systems
• SOP development, writing and implementation
• Developing SOPs, Work Instructions, Quality Manual
• Driving Gap Analysis
• Developing strategies for working towards retaining accreditation
• Escalating GCP and GCLP Compliance Issues.
• Promoting Quality Culture Awareness within the company
• Hosting all client audits and promoting the company Quality Management System
• Responsible for management and delivery of the audit program to include internal systems and vendor audits.
• Driving CAPA to completion for both internally identified GCP/GCLP non-compliance as well as non-compliance identified in audit.
• Generating metrics from reported deviation, CAPA to assist in process improvements
• SOP development, writing and implementation
• Developing SOPs, Work Instructions, Quality Manual
• Driving Gap Analysis
• Developing strategies for working towards retaining accreditation
• Escalating GCP and GCLP Compliance Issues.
• Promoting Quality Culture Awareness within the company
• Hosting all client audits and promoting the company Quality Management System
• Responsible for management and delivery of the audit program to include internal systems and vendor audits.
• Driving CAPA to completion for both internally identified GCP/GCLP non-compliance as well as non-compliance identified in audit.
• Generating metrics from reported deviation, CAPA to assist in process improvements
Writing, Audit, Management, Compliance, Quality Management, Hosting, Quality Assurance, Implementation, Development, Audit, UP, Manager
2014 - 2015
temp
Quality Manager (contract)
St Stephens AIDS Trust.
• Providing advice on setting up and establishing robust quality management systems
• Providing consultation advice on SOP development, writing and implementation
• Developing SOPs, Work Instructions, Quality Manual
• Driving Gap Analysis
• Developing strategies for working towards attaining regulatory accreditation
• Escalating GCP Compliance Issues.
• Responsible for promoting Quality within the company
• Hosting all client audits and promoting the company Quality Management System
• Responsible for management and delivery of the audit program to include internal systems audits, vendor audits and clinical study audits.
• Establishing working groups to begin planning for the phase 1 accreditation
• Liaising with sponsors/clients with respect to providing appropriate responses to audit findings and ensuring all responses provided are followed up to completion.
• Driving CAPA to completion for both internally identified GCP non-compliance as well AS non-compliance identified in audit.
• Reporting serious breaches to the MHRA and leading CAPA to completion.
• Member of the Management Team and escalated all ongoing issues to the team on a weekly basis.
• Providing consultation advice on SOP development, writing and implementation
• Developing SOPs, Work Instructions, Quality Manual
• Driving Gap Analysis
• Developing strategies for working towards attaining regulatory accreditation
• Escalating GCP Compliance Issues.
• Responsible for promoting Quality within the company
• Hosting all client audits and promoting the company Quality Management System
• Responsible for management and delivery of the audit program to include internal systems audits, vendor audits and clinical study audits.
• Establishing working groups to begin planning for the phase 1 accreditation
• Liaising with sponsors/clients with respect to providing appropriate responses to audit findings and ensuring all responses provided are followed up to completion.
• Driving CAPA to completion for both internally identified GCP non-compliance as well AS non-compliance identified in audit.
• Reporting serious breaches to the MHRA and leading CAPA to completion.
• Member of the Management Team and escalated all ongoing issues to the team on a weekly basis.
Writing, Audit, Management, Compliance, Quality Management, Hosting, Implementation, Development, Regulatory, Audit, UP, Manager
2012 - 2014
temp
QA Program Manager (contract)
Takeda Group Research & Development.
UK
• Deputized for the Clinical Quality Assurance ('CQA') Manager
• Developed, managed and executed strategic systems and/or process clinical QA audit programs for Takeda
• Oversaw the planning, conduct and execution of international audits of clinical sites, documents, databases, vendors and internal systems
• Managed audit teams, including outside contractor auditors
• Identified potential systemic compliance risks, through audit activities
• Provided GCP compliance support
• Acted as lead auditor for all audits conducted which were not sub-contracted to contractors
• Deputized for the Clinical Quality Assurance ('CQA') Manager
• Developed, managed and executed strategic systems and/or process clinical QA audit programs for Takeda
• Oversaw the planning, conduct and execution of international audits of clinical sites, documents, databases, vendors and internal systems
• Managed audit teams, including outside contractor auditors
• Identified potential systemic compliance risks, through audit activities
• Provided GCP compliance support
• Acted as lead auditor for all audits conducted which were not sub-contracted to contractors
Audit, QA, Compliance, Support, Quality Assurance, International, Audit, Manager
2011 - 2012
job
Senior CQA Auditor (permanent)
Chiltern International.
UK
• Deputized for the QA Manager (Europe) as appropriate
• Represented the QA group within the company
• Provided quality support and contributed to process improvement within QA and other departments
• Created (or supervised and/or coordinated the creation of) SOPs required for the proper functioning of the clinical trial process
• Managed European audit program and European auditor's calendars
• Acted as lead auditor for all audits conducted including training auditors
• Attended BARQA Auditing Computerized Systems
• Acted as lead auditor for Computer Systems Validation (CSV) audits
• Deputized for the QA Manager (Europe) as appropriate
• Represented the QA group within the company
• Provided quality support and contributed to process improvement within QA and other departments
• Created (or supervised and/or coordinated the creation of) SOPs required for the proper functioning of the clinical trial process
• Managed European audit program and European auditor's calendars
• Acted as lead auditor for all audits conducted including training auditors
• Attended BARQA Auditing Computerized Systems
• Acted as lead auditor for Computer Systems Validation (CSV) audits
Training, Audit, QA, Support, Audit, Manager
2010 - 2011
temp
GxP Compliance Manager
Spie Matthew Hall.
UK
• Introduced and managed continuous process improvements
• Developed and implemented a system for Change Control, CAPAs and Quality Incidents
• Ensured accurate individual training profiles ('ITPs') for all staff and Good Manufacturing ('GMP') contractors, including pre-qualification and competence
• Developed and managed a training database/system for compliance with ITPs
• Responsible for GxP administration team
• Developed internal and external audit programmes
• Developed archiving system
• Ensured 100% compliance to meet all administration standards set by Spie Matthew Hall, clients and other governing bodies
• Provided GxP/QA consultancy on behalf of Spie Matthew Hall to clients and major stakeholders
• Assured compliance with Medicines and Healthcare products Regulatory Agency ('MHRA') guidance for pharmaceuticals and manufacturers
• Executed internal and external audits to cover systems and vendors
• Presented compliance requirements during team meetings
• Developed a system of document control for SOPs, including periodic reviews
• Wrote and revised SOPs
• Coordinated SOP writing and revisions with other departments
• Developed and implemented security vetting procedures for contractor's access onto site
• Worked to ISO 9001:2008 standards
• Introduced and managed continuous process improvements
• Developed and implemented a system for Change Control, CAPAs and Quality Incidents
• Ensured accurate individual training profiles ('ITPs') for all staff and Good Manufacturing ('GMP') contractors, including pre-qualification and competence
• Developed and managed a training database/system for compliance with ITPs
• Responsible for GxP administration team
• Developed internal and external audit programmes
• Developed archiving system
• Ensured 100% compliance to meet all administration standards set by Spie Matthew Hall, clients and other governing bodies
• Provided GxP/QA consultancy on behalf of Spie Matthew Hall to clients and major stakeholders
• Assured compliance with Medicines and Healthcare products Regulatory Agency ('MHRA') guidance for pharmaceuticals and manufacturers
• Executed internal and external audits to cover systems and vendors
• Presented compliance requirements during team meetings
• Developed a system of document control for SOPs, including periodic reviews
• Wrote and revised SOPs
• Coordinated SOP writing and revisions with other departments
• Developed and implemented security vetting procedures for contractor's access onto site
• Worked to ISO 9001:2008 standards
Administration, Writing, Training, Database, Audit, QA, Compliance, Security, Gmp, Regulatory, Audit, Manager
2007 - 2009
job
CQA Auditor (permanent)
Pharm-Olam International UK.
UK
2007 - 2007
temp
CQA Auditor
GW Pharmaceuticals.
UK
2002 - 2006
job
Clinical Trials Administrator QA
Cancer Research UK.
QA, Administrator
My education
?
-
2002
University of North London
BSc, Microbiology
BSc, Microbiology
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