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Process Validation in Pharma Environment

$100-150 USD / hour

Closed
Posted over 5 years ago

$100-150 USD / hour

What we need is professionals with processes validation background. Validation in pharma environment, how to write protocols, tests, validations plans in a GxP regulated environment Validation Lead Skillset: · Direct computer system validation (CSV) experience · Use of quality center or electronic protocol/requirements systems (i.e. TIMS) · Strong written/verbal communication skills · Understanding of managing changes to validated systems in a regulated environment Key Deliverables in Validation Role: · Capable of leveraging technical knowledge/experience to apply in redlining URS, FRS, DS documents as a starting point for SMEs · Comfortable managing their own work with little direction/oversight · Able to take information from project team, PM, and readily apply to work · Able to understand the deep NN process (local & corporate) requirements such that work is driven by requirements, not necessarily the way it’s always been done · Set’s best practice with simplicity mindset · Capable of multi-tasking
Project ID: 18054889

About the project

11 proposals
Remote project
Active 5 yrs ago

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11 freelancers are bidding on average $122 USD/hour for this job
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I am a competent academic writer, with high lead times and turnaround time, proposal writer, masters level dissertation writer, PHD level dissertation and thesis writer, PHD defense PowerPoint presentation writer, argumentative essays, comparative analysis, company analysis, business strategy development, conversant with all international citations, marketing, management, business studies, advertising, procurement, strategy development, marketing plans, marketing strategy, communication strategies, stakeholder man. I have good reviews and record of writing excellent quality and a PhD level Essay, Thesis, dissertation. I can assure you about ZERO Plagiarism work. Give me a chance to join your team and i will prove myself. I believe in Quality … Let’s Discuss.
$138 USD in 40 days
4.8 (362 reviews)
7.4
7.4
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Expert in data entry offline and online. Fast typing skills with average about 80 words per minute. Excellent knowledge of word processing tools and spreadsheets (MS Office Word, Excel etc.) Working knowledge of office equipment and computer hardware and peripheral devices. Expert to Sort and organize paperwork after entering data to ensure it is not lost. Good command of English both oral and written and customer service skills
$44 USD in 40 days
0.0 (0 reviews)
0.0
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I have 7 years of validation experience in pharmaceutical industry. I have done process validation for so many bio-pharma products. Give me a chance to prove myself, I am sure you will find exactly what you need.
$100 USD in 40 days
0.0 (0 reviews)
0.0
0.0
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i am from pharma background, having 11 years of pharma industry and academic research experience, guided students of 15 post graduation students during my research tenure and recently working with pharma industry. So this will be win win situation to both.
$111 USD in 22 days
0.0 (0 reviews)
0.0
0.0
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I am a doctorate with 9 + years of experience in writing and editing. I have worked in analytical method development section of R & D division of a renowned biopharmaceutical company for a period of 2 years. I have prepared SOP, MOA, MQP, MQR and STP of various analytical methods. Also, I was involved in CSV of few instruments. Though the documentation was performed by third party, I had reviewed the documents including ATRs. My Ph.D. expertise and biopharmaceutical stint will definitely add value to your project.
$150 USD in 40 days
0.0 (0 reviews)
0.0
0.0
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Respected sir, My name is bhavik. My qualification is master of pharmacy in Quality assurance subject and i have been working with pharmaceutical company since 2012 with regulated plant like USFDA,MHRA,TGA and EU apparoved plant. I am expert in following area as mentioned below - Process validation -Preparation of qualification documents like URS, FAT protocol,GMP impact assessment,IQ,OQ and PQ. -Quality management system like change control, deviation,OOS ,CAPA and market complaint. I can complete your project as per your defined timeline and as per your requirement. If you have any query please fell free to ask. If you want than i can share my resume for your referecne. Regards, Bhavik
$138 USD in 40 days
0.0 (0 reviews)
0.0
0.0
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Working as Quality Head Proffessional in Pharmaceutical company with 15 years of Exp. in same field. Academic:B.Pharma. with MBA(Operations) Have complete hand on QMS(Quality Management Service) including Qualification documents review and its approval is my key responsibility in organisation. As per your requirement,can able to provide you with quality qualification documents. Awaiting for the your response to discuss project in detail. Thanks and Regards Vikas Bhopale
$166 USD in 8 days
0.0 (0 reviews)
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