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Improving Quality

Mariem Sarghini , London, United Kingdom


Experience

15 - 24 years

Other titles

Director Quality Assurance Senior Manager Quality Assurance Senior CQA Auditor (permanent) CQA Auditor (permanent)

Skills

Audit Gmp QA Qa management Quality assurance + 13 more

I'm offering


Markets

United Kingdom

Language

English
Fluently

Ready for

  Smaller project
  Larger project
  Ongoing relation / part-time

Available

Typically available right away

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.
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.
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
Writing, Audit, Management, Compliance, Quality Management, Hosting, Quality Assurance, Implementation, Development, Audit, UP, Manager


My education

? - 2002
University of North London
BSc, Microbiology


My resume

  Download resume



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