Automation Specialist for FDA Regulated Environments

1 month ago


Ahmedabad, Gujarat, India Instrumentation & Control Solutions Full time
Job Overview

Instrumentation & Control Solutions is seeking an experienced Automation Specialist to join our team. As a key member of our team, you will be responsible for performing Computer System Validation (CSV) on various systems and programs.

About the Role

This is a consulting position that requires a strong understanding of FDA cGMP regulations and computer validation methodologies. You will work closely with our clients to design, implement, and validate automation solutions that meet their specific needs.

Responsibilities
  • Perform CSV on a variety of systems and programs using your knowledge of FDA cGMP and related regulations and guidelines.
  • Collaborate with cross-functional teams to develop and implement automation solutions.
  • Design and execute validation plans, including IQ, OQ, PQ, RTM, and summary reports.
  • Maintain accurate and detailed documentation of all validation activities.
Requirements

To be successful in this role, you will need:

  • A minimum of 2 years of experience in computer system validation or related field.
  • Strong knowledge of FDA cGMP regulations and computer validation methodologies.
  • Excellent communication and project management skills.
  • Proficiency in MS Office tools and ability to learn new software quickly.
What We Offer

We offer a competitive salary range of $85,000 - $110,000 per year, depending on experience. Our benefits package includes health insurance, retirement plan, and paid time off. If you are a motivated and detail-oriented professional looking for a new challenge, please apply today



  • Ahmedabad, Gujarat, India Anvica Advisory Pvt. Ltd. Full time

    We are seeking a highly skilled Senior Automation Specialist to join our team at Anvica Advisory Pvt. Ltd.Job Overview:Anvica Advisory Pvt. Ltd. is a pioneering medical technology company dedicated to improving patient outcomes and quality of life.About the Role:The successful candidate will play a pivotal role in the design, development, and implementation...


  • Ahmedabad, Gujarat, India Automation System Engineers Pvt Ltd Full time

    Job Title: Senior Automation Sales SpecialistWe are seeking a seasoned Sales professional to join our team as a Senior Automation Sales Specialist. This role will be based in India and will be responsible for selling automation solutions to various industries.About the Role:Sales of automation solutions to various industries, with a focus on technical...


  • Ahmedabad, Gujarat, India Lifelancer Full time

    Medical Device Regulatory SpecialistWe are seeking a highly skilled Medical Device Regulatory Specialist to join our team at Lifelancer. In this role, you will provide direct Worldwide Regulatory support to various projects and products.About the Job:This is a challenging opportunity to work in the rapidly evolving field of Medical Device Regulation. You...


  • Ahmedabad, Gujarat, India Lifelancer Full time

    Regulatory Affairs Specialist Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to provide direct Worldwide Regulatory support to various projects and products. This role will involve strategic planning, product development efforts, and Regulatory support for existing products with respect to product changes/modifications,...


  • Ahmedabad, Gujarat, India Lifelancer Full time

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to provide direct Worldwide Regulatory support to various projects and products.Key Responsibilities:Support strategic planning and product development efforts by providing Regulatory guidance and expertise.Prepare and submit Regulatory documents to the FDA and other Regulatory...


  • Ahmedabad, Gujarat, India Lifelancer Full time

    About UsLifelancer is a talent-hiring platform in Life Sciences, Pharma and IT that connects professionals with opportunities.We are seeking a skilled Medical Device Regulatory Affairs Expert to join our team.The estimated salary for this role is $85,000 - $110,000 per year, depending on experience and qualifications.Job Description:We are looking for an...


  • Ahmedabad, Gujarat, India Lifelancer Full time

    Job Title:Regulatory Affairs Specialist - Sterile ProductsAbout UsLifelancer is a talent-hiring platform connecting professionals with opportunities in pharma, biotech, health sciences, and IT.Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. The ideal candidate will have expertise in sterile products ANDAs and...


  • Ahmedabad, Gujarat, India Eternal Robotics Full time

    Eternal Robotics is seeking a highly skilled Electrical Automation Specialist to join our team. In this role, you will be responsible for designing and installing electromechanical automation systems, ensuring seamless system operation and adhering to industry standards.Key Responsibilities:Design and install electromechanical automation lines and...

  • Automation Specialist

    6 hours ago


    Ahmedabad, Gujarat, India DynaTech Systems Full time

    Job OverviewDynaTech Systems is seeking an experienced Automation Specialist to join our team. This role involves designing, developing, and maintaining automated test scripts to ensure high-quality software releases.Key ResponsibilitiesAutomated Test Script Development:Design and develop automated test scripts using Selenium WebDriver and Core Java.Create...


  • Ahmedabad, Gujarat, India KiwiQA Full time

    About Our Team:We are looking for a skilled Test Automation Specialist to join our team at KiwiQA Services. As a Test Automation Specialist, you will play a crucial role in ensuring the quality and reliability of our web applications.Key Responsibilities:Understand client requirements and functional specifications.Identify test automation scope and prepare...


  • Ahmedabad, Gujarat, India Lifelancer Full time

    About the RoleAmneal is an equal opportunity employer, seeking a highly skilled Regulatory Affairs Specialist to join our team in Ahmedabad, Gujarat, India. The successful candidate will play a key role in ensuring timely submissions to the FDA for Injectable products.Responsibilities


  • Ahmedabad, Gujarat, India CMAA Advisors Private Limited Full time

    Senior Quality Assurance AutomationOverviewCMAA Advisors Private Limited seeks an experienced Senior Quality Assurance Automation Specialist to join our team. This role is responsible for developing and maintaining automated test suites, ensuring high-quality software releases.Job Description:Design, develop, and execute automation testing frameworks using...


  • Ahmedabad, Gujarat, India Lifelancer Full time

    About the Role:We are seeking a highly skilled Regulatory Affairs Specialist to provide direct Worldwide Regulatory support to various projects and products. As a key member of our team, you will be responsible for supporting strategic planning and product development efforts, and providing Regulatory support for existing products with respect to product...


  • Ahmedabad, Gujarat, India Softing Industrial Automation Full time

    **About Softing Industrial Automation**We are a leading provider of digital data exchange solutions in automation. Our goal is to offer easy-to-use products that are flexible, scalable, and future-proofed.**Job Description**As an Industrial Solutions Specialist, you will be responsible for providing technical advice and support to customers. This includes...


  • Ahmedabad, Gujarat, India Adani Group Full time

    About the RoleWe are seeking a highly skilled SOAR Automation Specialist to join our team at Adani Group. In this critical role, you will design, develop, and maintain advanced security automation workflows using Cortex XSOAR.Key Responsibilities:Develop and implement automated playbooks and integrations with various security tools, including SIEM, EDR,...


  • Ahmedabad, Gujarat, India Adani Group Full time

    Job Summary:We are seeking a highly skilled Cybersecurity Automation Specialist to join our team at the Adani Group. The successful candidate will be responsible for designing, developing, and maintaining advanced security automation workflows using Cortex XSOAR and Automation Anywhere. This is an exciting opportunity for a motivated individual with a...


  • Ahmedabad, Gujarat, India VOLANSYS (An ACL Digital Company) Full time

    OverviewVOLANSYS (An ACL Digital Company) is a leading provider of digital transformation solutions. As a Cloud Infrastructure Automation Specialist, you will play a key role in designing and implementing efficient CI/CD pipelines to streamline the delivery of new features.Job SummaryWe are seeking an experienced DevOps Engineer with expertise in cloud...


  • Ahmedabad, Gujarat, India Zenatix Solutions Full time

    Zenatix Solutions is seeking a highly skilled Technical Automation Specialist to join our team.Job DescriptionThis role involves troubleshooting and rectifying issues with RPI based Energy management systems, planning and inventory management, as well as troubleshooting field devices such as LT Panels, Relays, Contactors, and Energy Meters.You will be...


  • Ahmedabad, Gujarat, India Job In Gujarat Full time

    Job In Gujarat is a Recruitment & Training Service providing Company based in Ahmedabad, Gujarat and sister company of Virtual Height IT Services Pvt. Ltd.A strong presence in the market with over 08 years of establishment and a client database of 12000+ followers on Facebook makes the company a leading figure in recruitment & training business in...


  • Ahmedabad, Gujarat, India Rockwoods Inc Full time

    About Rockwoods IncRockwoods Inc is a leading provider of innovative solutions, dedicated to helping businesses thrive in today's fast-paced digital landscape.Salary and BenefitsThe salary for this position is estimated at $95,000 - $105,000 per annum, reflecting the company's commitment to attracting top talent.Job DescriptionWe are seeking an experienced...