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mali441

Muhammad A

@mali441

Quality Management Expert: ISO 9001, 13485, US FDA, EU MDR, GDP, cGMP

Pakistan
English, German, Urdu
About me
Hi, I’m Muhammad Ali, presently offering QMS services to German Company (Remotely from Pakistan) as a Quality Management Representative. My professional career of 11 years centers on establishing and implementing Policies, Corporate Procedures and compliance systems based on International Standards, US FDA and EU Regulations. Services I Offer: - ISO, US FDA, EU GDP, cGMP Documentation & SOP Development - Quality Manual Preparation - Internal Audits & Gap Analysis - CAPA & Risk Management - Supplier Qualification & Audit Support - QMS Training & Improvement... Read more

Skills

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mali441
Muhammad A
Offline • 

See my services

Certifications & Regulations
I will develop iso 13485 quality manual and sops for medical device
From$30 / projectMore details

Work experience

Medical

Part-time • 9 yrs 7 mos

Quality Management Representative | Medical Device & Bio-tech Pharma GmbH (Remote from Pakistan)

Nov 2022 - Present • 3 yrs 9 mos

- Developed and implemented a complete QM System from scratch in line with ISO 9001:2015 QMS & EU GDP requirements. - Integrated PDCA (PLAN, DO, CHECK, ACT) methodology into QMS processes for ongoing improvement. - Implemented a digital QMS solution with MS Office 365 professional for robust documentation. - Responsible for Annual Management Review Meeting and company-wide documentation. - Regularly write an article on QMS topics.

Snr. Quality Auditor (ISO 9001, ISO 13485 & US FDA QMS) | QSA Surgical (Pvt.) Ltd.

Apr 2016 - Feb 2022 • 5 yrs 10 mos

- Developed and implemented a Quality Management System (QMS) in all departments. - Successfully completed transition of ISO 9001 and ISO 13485 to new version in 2016. - Maintained complete QM documentation in electronic form or in paper form. - Executed Internal and Supplier Audits for continual improvement in system. - Prepared and assist Manager QA & RA to execute annual MRM. - Executed training to supervisors as per training calendar. - Performed regularly complex data analysis on MS Excel 365 for SPC & SQC analysis.

QMS Auditor & Trainer | American Global Standards

Consulting • Full-time

Nov 2014 - Apr 2016 • 1 yr 5 mos

- Performed certification audits and trainings on Intl. ISO Standards. - Carried out trainings on QMS, Quality tools & techniques, 5S, Kaizen.