Sterile Product Validation Expert

2 days ago

Allahabad, Uttar Pradesh, India beBeeValidation Full time ₹ 18,00,000 - ₹ 24,00,000

Job Opportunity

We are seeking a Validation Specialist to join our Quality Assurance team.

Key Responsibilities:

  • Develop, review, and approve validation protocols and reports for media fill studies, ensuring process integrity.
  • Analyze remote media fill results, identify areas for improvement, and recommend corrective actions.
  • Create and review area qualification protocols and reports for classified manufacturing areas based on environmental monitoring and qualification data.
  • Develop and review periodic requalification protocols, data, and environmental monitoring summaries for compliance with regulatory requirements.
  • Develop, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment.
  • Support the execution of Factory Acceptance Tests (FAT) for equipment at vendor locations, ensuring test protocols are followed and results are documented.
  • Develop and review utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation.
  • Develop, 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.
  • Maintain and update the Validation Master Plan (VMP), ensuring alignment with regulatory expectations and business needs.

Requirements:

  • Thorough understanding of sterile injectable manufacturing processes and aseptic techniques.
  • Expertise in validation methodologies and regulatory guidelines.
  • Strong analytical and problem-solving skills.
  • Effective communication and documentation skills.
  • Ability to manage cross-functional teams and prioritize tasks.
  • Proficiency in Quality Management Systems (QMS) tools and software.

About the Role

This is an exciting opportunity for a skilled professional to make a meaningful contribution to our organization.

What We Offer

A competitive compensation package, opportunities for career growth and development, and a dynamic work environment.

Contact Information

Please submit your application or contact us to learn more about this opportunity.

  • Product Specialist

    6 days ago

    Allahabad, Uttar Pradesh, India beBeeProductExpert Full time ₹ 10,00,000 - ₹ 15,00,000

    We are seeking a skilled Product Expert to join our team. As a Product Consultant, you will be responsible for demonstrating Caliber products to customers, conducting on-site build installations and configurations, and ensuring thorough understanding of customer requirements.Primary Responsibilities:Demonstrate Caliber products to customers.On-site build...

  • Senior System Validator

    6 days ago

    Allahabad, Uttar Pradesh, India beBeeValidator Full time ₹ 15,00,000 - ₹ 25,00,000

    About People Prime Worldwide:We are a leading software giant with over 11.3 billion dollars in revenue, a global workforce of 240,000 employees, and presence in 60+ countries.Our team is seeking a skilled Validation Engineer to join our ranks.Key Responsibilities:Develop and maintain computer system validation plans and reportsConduct risk assessments and...

  • Senior Silicon Validation Engineer

    5 days ago

    Allahabad, Uttar Pradesh, India beBeeDebugger Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Trace and Debug ExpertWe are seeking a seasoned Trace and Debug expert with deep hands-on expertise in silicon bring-up, low-level debugging, and advanced trace methodologies.This role demands proficiency with JTAG, ETM, CoreSight, and industry-standard debug tools, as well as the ability to collaborate closely with silicon, hardware, and firmware teams to...

  • System Validation Specialist

    5 days ago

    Allahabad, Uttar Pradesh, India beBeeQuality Full time US$ 12,00,000 - US$ 15,00,000

    About Our Company:We are a global technology organization that provides IT, consulting, and business process services.We specialize in cloud computing, computer security, digital transformation, artificial intelligence, robotics, data analytics, and other technologies to drive business growth.Key Responsibilities:Lead the validation of computer systems to...

  • Senior Data Validation Specialist

    6 days ago

    Allahabad, Uttar Pradesh, India beBeeDataValidator Full time ₹ 15,00,000 - ₹ 20,00,000

    Job Title:A Tester Role AwaitsWe are seeking a highly skilled tester to join our team. As a tester, you will be responsible for testing and validation support in the system as per bank's internal policies and requirements.Mandatory Skills:Knowledge of MT103 + MT202 ( SWIFT Payments)Key Responsibilities:Ensure accurate and efficient understanding along with...

  • Civil Construction Expert

    2 days ago

    Allahabad, Uttar Pradesh, India beBeeCostExpert Full time ₹ 12,00,000 - ₹ 20,00,000

    Job Title: Civil Construction ExpertWe are seeking an experienced Civil Construction Expert to join our team. As a key member of our construction team, you will play a vital role in ensuring the successful delivery of high-quality construction projects.Your primary responsibility will be to manage the costs associated with construction projects, including...

  • Senior Production Operations Specialist

    4 days ago

    Allahabad, Uttar Pradesh, India beBeeProductionManager Full time ₹ 15,00,000 - ₹ 20,00,000

    Production Manager Job DescriptionWe are seeking a highly skilled Production Manager to oversee our daily operations and ensure that all activities are conducted in alignment with company objectives.This role involves managing staff, optimizing processes, and quality management systems with high standards. The successful candidate will be responsible for...

  • Medical Devices Specialist

    1 week ago

    Allahabad, Uttar Pradesh, India beBeeDevice Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Job Opportunity:As a Senior Device Engineer, you will be responsible for assessing and auditing medical devices to ensure compliance with regulatory standards.Key Responsibilities:Evaluate quality management systems of manufacturers to ensure they meet ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations standards.Conduct risk management audits...

  • Aerospace Technology Expert

    2 days ago

    Allahabad, Uttar Pradesh, India beBeeElectronics Full time ₹ 10,00,000 - ₹ 20,00,000

    Job Title: Aerospace Technology ExpertThis is a unique opportunity to join a dynamic team in the aerospace industry. As an expert in mechatronics and electronics, you will play a key role in developing and implementing electro-mechanical systems for avionics and electronic systems.About the Role:We are looking for an experienced engineer who can spearhead...

  • Advanced Medical Device Developer

    5 days ago

    Allahabad, Uttar Pradesh, India beBeeMechanical Full time ₹ 1,20,00,000 - ₹ 1,50,00,000

    Medical Device DesignerThe role involves conceptualizing, designing, and developing innovative medical devices that enhance patient lives.Key Responsibilities:Developing novel mechanical systems and sub-systems for medical devices from concept to production.Designing new products or components to meet specific performance, aesthetic, and functional...