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    Job · 18760302

    HYDERABAD · FULLTIME

    DQA

    Chieron Active Ingredients logo

    Chieron Active Ingredients

    Hyderabad · onsite · Posted 29d ago

    Sourced fromNaukri
    Undisclosed7–10 yrsfulltimeHyderabad

    About a minute. You'll make an account on the way through.

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    Section · 01

    About this role

    Role:
    Responsible for Quality oversight and assurance for API R&D, process development, scale-up, technology transfer, and CDMO projects, ensuring development activities are scientifically sound, compliant, and inspection-ready.


    Key Responsibilities:

    • Quality oversight of API R&D and process development activities.
    • Review/approval of development reports, specifications, analytical methods, process validation/optimization and technology-transfer documents.
    • Ensure GMP, data integrity, ICH and regulatory expectations are incorporated during development.
    • Quality review of new molecule/process development and CDMO projects.
    • Support regulatory submissions, customer audits and regulatory inspections.
    • Establish and strengthen DQA systems for API R&D and development projects.

    Preferred Profile:

    • Strong experience in API R&D Quality / QA / Quality Assurance for development.
    • Good understanding of API chemistry, analytical development, QMS, GMP and regulatory requirements.
    • Experience with new molecules, process development, scale-up and technology transfer is preferred.
    • Strong communication, scientific review and cross-functional coordination skills.

    Sourced from naukri

    Section · 02

    Skills

    technology transferprocess developmentDQA

    Section · Company

    About Chieron Active Ingredients

    Chieron Active Ingredients logo

    Chieron Active Ingredients

    Pharma

    None

    headquarters

    ₹10.6L PA avg

    Avg at Chieron Active Ingredients

    About

    Chieron has established a strong presence in specific therapeutic segments such as cardiovascular and central nervous system (CNS). The company aspires to maintain its market leadership in these areas by continuously adding new molecules and expanding its global footprint. VNAIs strategy includes global filings and approvals for all its products, enabling the company to engage with key customers worldwide. This approach has helped the company build a sustainable business model with a well-organized production and inventory planning system.


    Chieron stands as a pioneer manufacturer of unique niche Active Pharmaceutical Ingredients (APIs), holding prestigious approvals, including six Certificates of Suitability (COS) Approval, USFDA, and Korean FDA Approvals. But our journey doesnt end here; we are tirelessly pursuing approvals from ANVISA and the Chinese cFDA for our key products.


    Established in the year 2007, our mission has always been clear: Delivering Best Quality and Cost Leadership in the supply of Intermediates & APIs to customers globally while achieving the highest levels of customer satisfaction.


    Our strategic focus on Backward Integration not only ensures cost competitiveness but also guarantees supply reliability and impeccable quality control. We proudly serve as a Contract Development and Manufacturing Organization (CDMO/CMO) partner to esteemed clients across Europe, Japan, and the Korean Region and expanding our presence Globally.

    Innovation is at our core, with world-class Research and Analytics Laboratories facilitating new product development, alongside a Pilot plant conveniently located on-site. Our Compliance trails show the strength about our quality systems.

    Industries

    Pharma

    Employee ratings

    4 reviews

    3.5/ 5

    Culture

    3.8

    Career growth

    2.8

    Work-life

    3.5

    Employees rate it well for

    Company Culture37Job Security37

    Find them on

    WebsiteAmbitionBox reviews

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