GMP Facility Validation -- 2

$10-30 USD

Imefungwa

Imechapishwa

almost 4 years ago

$10-30 USD

Kulipwa wakati wa kufikishwa

I need two separate bits of help in this project- 1. I need someone who can explain me below topics concerning FDA ISO Standards 2. Also, prepare the sample documents for the following points. 1. Installation Qualification Protocol Document (IQ): 1.1 HVAC calibration 1.2 HEPA filter integrity test 1.3 Site Acceptance Tests(SATs) 1.4 Installation Qualification tests 1.5 Piping and welding documentation 1.6 Utility verification 1.7 Environmental review report 2. Operational Qualification Protocol Document (OQ): 2.1 HVAC Testing 2.2 Alarms(Interlock and Critical) 2.3 Air Flow Patterns and flow Rate 2.4 Pressure differential 2.5 Temperatures and Humidity 2.6 Personnel contamination Control 3. Performance Qualification (PQ): 3.1 Testing and Monitoring 3.1.1 Differential pressure 3.1.2 Temperature and humidity 3.1.3 Surface and Airborne Particulate levels 3.1.4 Microbial particulates

Biotechnology

Engineering

Process Validation

Quality and Reliability Testing

Kitambulisho cha mradi: 25716240

Kuhusu mradi

8 mapendekezo

Mradi wa mbali

Inatumika 4 yrs ago

Unatafuta kupata pesa?

Barua pepe

Faida za kutoa zabuni kwenye Freelancer

Weka bajeti yako na muda uliopangwa

Pata malipo kwa kazi yako

Eleza pendekezo lako

Ni bure kujiandikisha na kutoa zabuni kwa kazi

8 wafanyakazi huru wana zabuni kwa wastani $110 USD kwa kazi hii

@morsadanam

Hello... Greetings... I am a Project consultant and Regulatory expert from India. I have more than 8years of experience End to Project Management for Plant Setup, Validation, Project Execution including HVAC Validation as per ISO, WHO, EU or FDA. I have worked with many Pharma companies like CIPLA, Torrent Pharma strides shasun, and amenal pharmaceutical as a Project Manager. I have successfully completed a similar project in freelancer I can help you to review 1. AFD Drawing 2. Detailed design Drawing 3. Pressure Balancing 4. Machine Placement Drawing, Man and material movement 5. Hvac Drawing 6. Complete Validation Lifecycle (From IQ OQ PQ) The budget and the Scope of work is not compatible, we can discuss over the Scope of work, I will send my CV during interview I understand your requirement and I can help you to execute this project. looking forward to work on this project. I am available for Skyp interview. regards Anam

$700 USD ndani ya siku 7

5.0

(1 hakiki)

3.1

@munyakalucky

Hello, I have a Bachelor’s degree in pharmacy hence I can work successfully on your project. I also have adequate experience in medical writing. Please contact me so that we can discuss more. I am looking forward to working with you. Thank you.

$30 USD ndani ya siku 7

4.8

(4 hakiki)

2.7

@EngrShahzad24

I am a professional HVAC Engineer. Having more then 5 years of experience in UAE market. I saw your given details. I have complete knowledge about it. If you pick up my bid I will be happy to provide you my expertise.

$30 USD ndani ya siku 6

0.0

(0 hakiki)

0.0

@tauseefazam15

I am a Mechanical HVAC engineer have 6 year experience for design estimation and testing filed

$25 USD ndani ya siku 4

0.0

(0 hakiki)

0.0

@zaidiabdullah

I have 11 years of experience in qualification.. it is not difficult to complete the task given as it is my expertise. Relevant Skills and Experience I am a Certified Quality Engineer and Experienced Validation Specialist with a demonstrated history of working in the Pharmaceuticals industry. Skilled in equipment and facilities qualification.

$25 USD ndani ya siku 7