Process Validation in Pharma Environment

$25-50 USD / hour

Suljettu

Julkaistu

yli 5 vuotta sitten

$25-50 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

Research Writing

Technical Writing

Projektin tunnus (ID): 18033589

Tietoa projektista

15 ehdotukset

Etäprojekti

Aktiivinen 5 vuotta sitten

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15 freelancerit tarjoavat keskimäärin $43 USD/tunti tätä projektia

@topacademics

Hi, topacademicse will give you best work in Validation in pharma environment about how to write protocols, tests, validations plans in a GxP regulated environment. kindly discuss details regards Rashid.

$50 USD 40 päivässä

4,9

(741 arvostelua)

8,3

@Thoughtfulwrites

I excel in the fields of technical writing and content management projects. I have spent the past five years providing IBM, and a multitude of companies ranging greatly in size, with high quality, innovative technical articles, reviews, and rewrites. I have assisted organizations in drafting their content management strategies, and have seen the execution of these strategies through to the finish. My experience with editing and writing technical content has provided me with ample opportunity to hone my research skills. I am well aware of the intricacies involved in translating detailed research into clearly conveyed, relevant information. My solid background in business communication theory, combined with my extensive practical experience in the field, enable me to provide the absolute best quality available.

$50 USD 40 päivässä

4,8

(184 arvostelua)

7,8

@braincenter

I believe that my experience and skill in this background will prove to be of great help to you. Contact me to discuss more on the details

$41 USD 40 päivässä

4,8

(78 arvostelua)

5,9

@funnyhoney

Past experience in validation. PMP certified project manager, MBA, business analyst, market researcher,writer, proficient in the field of business plans, presentations, SEO, social media, Adwords project management, presentations, marketing and branding, HR, operations, real estate, contracts, finance, legal, health, teams, training. Experience 10 years. Willing to offer-free trial and looking for a long-term work association.

$27 USD 40 päivässä

4,8

(28 arvostelua)

5,4

@Geeks99

Hello, We are so glad to share our proposal for writing protocols, tests, validations plans in a GxP regulated environment. We are a team of great research and report writers who are specialist in writing research papers and reports related to different subjects. We provide informative and authentic papers in a very creative manner. Please send us a message for further discussion. Thanks Regards, EG Ltd

$25 USD 40 päivässä

4,9

(24 arvostelua)

4,6

@manishdudhani

14 years of Pharmaceutical product Development and technical transfer of validation, CPV,critical process parameters. experience in writing technical protocol,validation protocol.

$44 USD 20 päivässä

0,0

(0 arvostelua)

0,0

@morsadanam

Hello, Greetings... I am a Computer system validation expert. I have 6 years experience in validation project. I have worked with many pharma MNC like Cipla Ltd, Torrent Pharmaceutical Ltd, Strides Shasun, Parsan Engineers and Consultants. I have great knowledge about validation lifecycle. preparation of validation protocol (DS, IQ, OQ, PQ) I understand your requirements, I can help you to execute this project. Hope we will have a communication soon. Regards Anam

$44 USD 40 päivässä

0,0

(0 arvostelua)

0,0

@JayC09

I am familiar with USP and ASTM guidelines and also I am members of various Pharma societies like PMFlist where I get up to date information on industry trends, methods and QC checks. I will be happy to listen to your requirements in greater details should you choose to work with me.

$50 USD 40 päivässä

0,0

(0 arvostelua)

0,0

@ps22in

I have 3 years of experience in implementing IT solutions for pharma company in India. I have implemented MES, HPLC, Learning Management System, Document Management System and ELN. Further, I am in a full-time consulting job with access to guidance in case required. I am looking to build my expertise in process validation which is why I am bidding for this project

$41 USD 40 päivässä

0,0

(0 arvostelua)

0,0

@PenelopeGuzman

I am a pharmacist on sabbatical who has also moonlighted as a writer for almost ten years (writing for various online publications). I have both a healthcare background and writing/editing experience. Thank you for your consideration!

$41 USD 40 päivässä

0,0

(0 arvostelua)

0,0

@ivanasavanja

Hello I have experience of more than 10 years working as QA Manager in Pharmaceutical industry. You can see my CV on my Linkedin (ivanamilanovic7)

$55 USD 5 päivässä

0,0

(0 arvostelua)

0,0

@Firmwicky

I have been writing different types of articles and therefore am very familiar with the guidelines that revolves around article writing such as good content skills, good grammar skills, being creative and critical thinking as well. Creating a unique and original article and free from plagiarism, I write articles within the time frame given and with maximum speed and accuracy as a priority.

$41 USD 40 päivässä

0,0

(0 arvostelua)

0,0

@PhDPrachi

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 CSV documents including ATRs. My Ph.D. expertise and biopharmaceutical stint will definitely add value to your project

$50 USD 40 päivässä

0,0

(0 arvostelua)

0,0

@Sanketshah303

Hands on experience in preparation of protocols &reports for IQ, OQ, PQ & RQ, other validation deliverable (URS, Gap Assessment, Risk Assessment, Compliance Report, Tractability Matrix, Summary report and interim reports etc. Good Exposure on Regulatory requirements of Computerized Systems and sound knowledge of GxP, GAMP, EU Annex 11 and USFDA 21 CFR Part 11, 210 and 211. Good knowledge on Preparation, review and ensure compliance of, Project Validation Plan, Corporate & site specific Policies and Procedures.

$41 USD 40 päivässä