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mali441

Muhammad A

@mali441

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

Pakistan
Engels, Duits, Urdu
Sommige informatie wordt in het Engels weergegeven.
Over mij
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... Lees meer

Skills

m
mali441
Muhammad A
offline • 

Bekijk mijn diensten

Certificeringen en regelgeving
I will develop iso 13485 quality manual and sops for medical device
VanafUS$ 30 / projectMeer informatie

Werkervaring

Medical

Parttime • 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 • Fulltime

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.