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 ?

Book a free call

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

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Contact-me

Please feel free to contact me :

getyourcompliance@gmail.com

+971 58 504 5773

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