Senior Sterile Manufacturing Validator

3 days ago

Nashik, Maharashtra, India beBeeValidation Full time ₹ 15,00,000 - ₹ 20,00,000

Validation Specialist Opportunity

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We are seeking a seasoned Validation Specialist to join our Quality Assurance team. As a key member of the department, you will play a vital role in ensuring the integrity of our sterile injectable manufacturing processes and maintaining compliance with regulatory requirements.

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  • Main Responsibilities:","
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    • Develop, 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.","
    • 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.","
    • Develop, review, and approve process validation protocols, data, and reports to confirm process robustness and consistency in product quality.","
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  • Key Skills and Competencies:","
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    • 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.","
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What We Offer:

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We offer a dynamic work environment, opportunities for professional growth, and a competitive compensation package.

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If you are a motivated and experienced validation specialist looking for a new challenge, please submit your application.

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We look forward to hearing from you

"]},

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