Urgent: QA-Validation

3 weeks ago


India Medivant Healthcare Full time
Salary Between 15-20 Lacs

QA-Validation – Sterile Injectables (Candidate with B1/B2 USA Visa Preferred)

Experience Required: 10-15 years

Location: Remote

Department: Quality Assurance

No. of vacancy: 01

Key Responsibility:

Validation Activities:

- Prepare, review, and approve validation protocols and reports for media fill studies, ensuring aseptic process integrity.
- Analyze remote media fill results, identify deficiencies, and recommend corrective or preventive actions.
- Prepare and review area qualification protocols and reports for classified manufacturing areas (Grade A–D) based on environmental monitoring and qualification data from the site.
- Prepare and review periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements.
- Prepare, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment.
- Support and participate in Factory Acceptance Test (FAT) execution for equipment at vendor locations (onsite when required, otherwise through live remote connection), ensuring test protocols are followed and results are documented.
- Prepare and review utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation.
- Prepare, review, and approve cleaning validation protocols and reports to ensure adequacy, compliance, and suitability for product changeover.
- Prepare, review, and approve process validation protocols, data, and reports to confirm process robustness and consistency in product quality.
- Maintain and update the Validation Master Plan (VMP), ensuring alignment with regulatory expectations and site needs

Key Skills and Competencies:

- In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
- Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.).
- Strong analytical and problem-solving skills.
- Effective communication and documentation skills.
- Ability to manage cross-functional teams and prioritize tasks.
- Proficiency in QMS tools and software.

Education and Qualifications:

- Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
  • QA Engineer

    2 days ago


    India Fello Full time

    Job Description About Fello Fello is a profitable, hyper-growth, VC-backed B2B SaaS startup on a mission to empower businesses with data-driven intelligence. Our AI-powered marketing automation platform helps businesses optimize engagement, make smarter decisions, and stay ahead in a competitive market. With massive growth potential and a track record of...


  • India MindBrain Full time

    Job Description Position: Senior QA Engineer Experience: 5+ years Location: Remote About the Role We are building a modern, scalable web platform using Drupal (backend) and Next.js (frontend). We are looking for a skilled QA Engineer to ensure quality across the platform through manual and automated testing, accessibility checks, and seamless...


  • Chennai, India Capgemini Full time

    Job Description Job Description QA Automation Test Engineer Location:Chennai, India Work Mode:Hybrid (3 days/week from office) Experience Required: 9-12 years Qualifications:Bachelor's or master's degree in engineering ---------------------------------------- About the Role We are looking for a detail-oriented and technically skilledQA Automation Test...

  • QA Engineer

    1 week ago


    Hyderabad, India algoleap Full time

    Job Description We have a QA opening with the following skill requirements: - Mandatory: Playwright with JavaScript - Optional: Salesforce, API automation using Rest Assured or similar tools, AI/Prompt Engineering Please let me know if you know someone who might be a good fit or feel free to share this with interested candidates. Please feel free to look...


  • Bengaluru, India Ecolab Full time

    Job Description - Bachelor degree/BTech in Computer Science or related discipline or 3+ years of experience as a QA/Tester - Must have 2+years of Manual testing experience - Experienced Test Engineer with a strong hands-on in creating Test design, Test cases, with extensive experience in Manual, System and Functional Testing - Having strong Integration...

  • Salesforce QA Analyst

    3 hours ago


    India Netskope Full time

    Job Description About Netskope Today, there's more data and users outside the enterprise than inside, causing the network perimeter as we know it to dissolve. We realized a new perimeter was needed, one that is built in the cloud and follows and protects data wherever it goes, so we started Netskope to redefine Cloud, Network and Data Security. Since...


  • Ahmedabad, India Astound Digital Full time

    Job Description About Astound Digital At Astound Digital, we are pioneers in the digital landscape, dedicated to transforming how the world interacts with technology, data, and creativity. Our role as trusted advisors in the digital landscape empowers the world's most innovative brands with frictionless, end-to-end customer experiences. We are known for...


  • India Motive Technologies Full time

    Who we are Motive empowers the people who run physical operations with tools to make their work safer more productive and more profitable For the first time ever safety operations and finance teams can manage their drivers vehicles equipment and fleet related spend in a single system Combined with industry leading AI the Motive platform gives you...


  • Gurugram, India NGA Human Resources, an Alight company Full time

    Job Description Our story At Alight, we believe a companyu2019s success starts with its people. At our core, we Champion People, help our colleagues Grow with Purpose and True to our name we encourage colleagues to u201CBe Alight.u201D Our Values: Champion People u2013 be empathetic and help create a place where everyone belongs. Grow with purpose u2013...

  • PMO Role #1

    1 week ago


    India QA InfoTech Full time

    Description 4-5 years of experience in providing PMO support Good communication and co-ordination skills are essential. Good Microsoft Excel skills are essential. 1.Provide Management Reports - Overall progress and Health of Projects - Status of Milestones and Deliverables across the Portfolio - Financial Information about the budget, Forecast, Actuals,...