Your site compliance ensured or enhanced
"Compliance is not a one-time action but a continuous effort to be made by all of us as an actor within pharmaceutical, medical devices and FMCGs industries."
My services
INSPECTION READINESS
To ensure a readiness at all time
Self inspection
Implement a self-inspection program: areas covered, yearly planning, personnel to be involved, training needs, KPIs
Coaching
Implement coaching material for Subject Matter Experts before any audit/inspection
Audit strategy
Implement a end-to-end virtual or hybrid audit strategy
Compliance gaps
Identify compliance risks and associated gaps, provide guidance for compliance gaps classification, ensure mitigation/remediation plans of compliance gaps and associated risks
Risk management
Establish or support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks.
AUDITS
To be the best prepared for any audit
Pre audit
Assist in the preparation of audits : strategy (audit team definition, tools, specificities, etc.) and logistics
Audit execution
Assist the backroom and provide guidance for a smooth execution
Post audit
Assist in the responses and CAPAs to observations/recommendations
DATA INTEGRITY
To ensure a data governance program in place
Compliance
Identify Data Integrity compliance gaps and improvements
Guidance
Provide guidance to support SMEs in defining changes to ensure DI compliance
You want to talk about your project ?
QUALITY SYSTEM
To ensure a sustainable, robust and effective QMS
Quality System Processes
Assess and improve the Non Conformances, CAPAs, Internal Audits/self-inspection, and Management Review processes
Reporting
Define and ensure reporting of site Quality Systems KPIs
Continuous improvement
Build the Quality Management System taxonomy and
act as Business Process Manager for a QMS simplification
TRAINING
To ensure a sustainable, robust and effective training governance program
Training needs
Define training needs for all relevant employees
Qualification matrix
Implement a qualification matrix for any Learning Management System
Records management
Ensure all relevant employees are trained and records maintained
Monitoring
Define a monitoring system for tracking training compliance and define a process for escalation of persistent non-compliance.
COACHING FOR INTERVIEW PREPARATION
To be the best prepared for any job interview
I am dedicated to teaching individuals how to be the best prepared for any interview and to develop the confidence needed to smoothly run the interview.
I am providing tips and guidance on how companies try to find the best suitable candidate.
I am preparing some role plays and case studies and I will provide you constructive feedback and strategies to anticipate and perform well in a job interview.
The coaching can be held in French or in English.
My commitments
Quality
To provide a high-quality work and ensure your satisfaction
Adaptability
To focus on caring for your needs and enable a suitable and customized offer
Simplicity
To facilitate interactions and maintain a trustworthy relationship
About myself
Biomedical engineer bringing a unique blend of industry expertise dealing with FMCGs and pharmaceuticals within international companies in Switzerland.
Diligent, accountable and result-driven professional responsible for quality systems and compliance activities and experienced in quality improvements initiatives.
I can operate remotely for European-based companies or onfor Dubai-based companies.
My main objective is to contribute to the maintenance and improvement of site compliance with applicable external local requirements/regulations and company requirements.
Let's talk !
Julie Zingarelli
Contact-me
Please feel free to contact me :
getyourcompliance@gmail.com
+971 58 504 5773