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I will do cgmp documentation and sops
ISO 13485, MDR 2017 745, FDA Regulatory Affairs, Medical Device QMS Expert
Hi, Greetings!
I am a Medical Device Regulatory and QMS expert with over 20 years of experience in regulated industries. I am an IRCA Approved Lead Auditor for ISO 9001:2015 & ISO 13485:2016 and speci...
Level 2
Has met high performance criteria and has a proven track record for meeting client expectations.
About this Gig
Hi, Greetings!
If you are in need of top-notch Standard Operating Procedures (SOPs), a comprehensive GMP documentation plan, consultation services, and assistance with FDA Registration, I am ready to collaborate with you.
With my extensive experience in the field, I specialize in providing comprehensive solutions for various industries. Whether you require SOPs, GMP documentation, or guidance on compliance and FDA Registration, I am well-equipped to meet your needs.
I will prepare all cGMP documents, protocols, and SOPs in accordance with FDA regulations such as 21 CFR 820, as well as international guidelines.
The following procedures will be developed, but not limited to, the ones listed below:
Facility Layout
Manufacturing Processes
Insect & Rodent Control
Master Validation Plans
House Keeping / Sanitation
Internal Audits
Calibration & Maintenance
Device Master Record (DMR)
Device History Record (DHR)
FDA Inspections
Material/Product Acceptance
Manufacturing Inspection & Checklist
Employee Training
Document Control & Records
Analysis of Data
Nonconformance
Recall
Complain Handling etc.
Looking forward to working with you to achieve operational Excellence.
Regards,
My Portfolio
FAQ
What are SOPs, and why are they important for my business?
Quality Manual & SOPs (Standard Operating Procedures), are essential documents that outline the processes and procedures required to maintain a quality management system in compliance with ISO 9001 and consistency in manufacturing operations.
How can your SOPs and full documentation services benefit my business?
My SOPs and full documentation services provide numerous benefits for your business. They help establish standardized processes, improve product quality, reduce rework/rejection, ensure regulatory compliance, enhance operational efficiency and mitigate risks.
Can you create Quality Manual & SOPs that are specific to my industry or business?
Absolutely! I specialize in creating customized SOPs that are tailored to your industry and business needs. By understanding your unique processes, requirements, and regulatory landscape, I will develop SOPs that align perfectly with your operations and quality manual.
How do you ensure that the QMS SOPs and full documentation you provide are up-to-date and compliant?
As an experienced professional, I stay updated with the latest industry regulations, guidelines, ISO Standards & best practices. I provide accurate, compliant, and reflect the current regulations & QMS requirements.
Reviews
2 reviews for this Gig
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Rating Breakdown
- Seller communication level
- Quality of delivery
- Value of delivery
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Most relevant
S shoaibkhan40795
Repeat Client
Saudi Arabia
Excellent work and very professional service. The communication was smooth, timely, and highly efficient. I truly appreciate the effort
Up to $50
Price
3 weeks
Duration
N 
Seller's Response
Helpful?N nyxemu
United States
Detail oriented
$400-$600
Price
12 days
Duration
Helpful?
Reviews
2 reviews for this Gig
| (2) | ||
| (0) | ||
| (0) | ||
| (0) | ||
| (0) |
Rating Breakdown
- Seller communication level
- Quality of delivery
- Value of delivery
Sort By
Most relevant
S shoaibkhan40795
Repeat Client
Saudi Arabia
Excellent work and very professional service. The communication was smooth, timely, and highly efficient. I truly appreciate the effort
Up to $50
Price
3 weeks
Duration
N Seller's Response
Helpful?N nyxemu
United States
Detail oriented
$400-$600
Price
12 days
Duration
Helpful?
