Sterile Injectable Manufacturing Quality Assurance Expert

4 days ago

Jodhpur, Rajasthan, India beBeeQuality Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Job Description

We are seeking an experienced Quality Assurance Specialist to oversee the integrity of our sterile injectable manufacturing processes. This role involves ensuring quality and compliance with regulatory requirements.

  • Preparation, review, and approval of validation protocols and reports for media fill studies, emphasizing aseptic process integrity.
  • Analysis of remote media fill results, identification of deficiencies, and recommendation of corrective or preventive actions.
  • Preparation and review of area qualification protocols and reports for classified manufacturing areas (Grade A–D) based on environmental monitoring and qualification data from the site.
  • Preparation and review of periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements.
  • Preparation, review, and approval of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment.
  • Support and participation 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.
  • Preparation and review of utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation.
  • Preparation, review, and approval of cleaning validation protocols and reports to ensure adequacy, compliance, and suitability for product changeover.
  • Preparation, review, and approval of process validation protocols, data, and reports to confirm process robustness and consistency in product quality.
  • Maintenance and update of the Validation Master Plan (VMP), ensuring alignment with regulatory expectations and site needs.

Requirements

  • Proficiency in sterile injectable manufacturing processes and aseptic techniques.
  • Knowledge of 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.

Qualifications

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

  • Quality Assurance Specialist for Sterile Injectables

    4 days ago

    Jodhpur, Rajasthan, India beBeeQuality Full time ₹ 15,00,000 - ₹ 20,00,000

    Job SummaryWe are seeking a Quality Assurance Specialist to join our team. The ideal candidate will have in-depth knowledge of sterile injectable manufacturing processes and aseptic techniques, as well as expertise in validation methodologies and regulatory guidelines.Key Responsibilities:Review and approve executed Batch Manufacturing Records (BMRs) and...

  • Senior Pharmaceutical QA Compliance Specialist

    2 weeks ago

    Jodhpur, Rajasthan, India beBeeQuality Full time ₹ 20,00,000 - ₹ 25,00,000

    Job RoleThe Quality Assurance Compliance Specialist plays a vital role in ensuring the quality and compliance of sterile injectable manufacturing processes.

  • Quality Assurance Expert

    1 week ago

    Jodhpur, Rajasthan, India beBeeQuality Full time ₹ 9,00,000 - ₹ 12,00,000

    Job Title: Quality Assurance ExpertWe are seeking an experienced Quality Assurance Expert to join our team in the travel industry.Key Responsibilities:A minimum of 1 year of experience in quality assurance roles within the travel process is required.Strong knowledge of GDS, Galileo, and Amadeus systems is necessary for this position.Candidates with...

  • Senior Quality Management Specialist

    1 week ago

    Jodhpur, Rajasthan, India beBeeQualityManagement Full time ₹ 12,48,000 - ₹ 22,45,600

    Are you an expert in quality management and medical devices?We are seeking a seasoned professional to lead the development and implementation of quality management systems, ensuring compliance with regulatory requirements.This role involves collaborating with cross-functional teams to design and manufacture medical devices, focusing on non-active devices and...

  • Quality Assurance Expert

    3 days ago

    Jodhpur, Rajasthan, India beBeeAutomation Full time ₹ 18,00,000 - ₹ 25,00,000

    We are seeking a skilled Quality Assurance Expert to play a key role in ensuring product quality.The ideal candidate will have experience in test automation and quality assurance, specifically within the Banking domain.You will develop and maintain automation strategies, execute test cases, and collaborate with cross-functional teams to deliver secure,...

  • Quality Assurance Professional

    1 week ago

    Jodhpur, Rajasthan, India beBeeQuality Full time ₹ 60,00,000 - ₹ 1,20,00,000

    Quality Assurance SpecialistWe are seeking a Quality Assurance Specialist to ensure the highest standards of quality in our products.Develop and implement quality inspection standards and judgment criteria for our products, ensuring that they meet or exceed industry requirements.Monitor process control in our manufacturing facility and drive continuous...

  • Quality Assurance Specialist

    1 day ago

    Jodhpur, Rajasthan, India beBeeQuality Full time ₹ 35,00,000 - ₹ 40,00,000

    Job Title: Quality Assurance SpecialistOverview: We are seeking a skilled and quality-conscious professional with a background in manufacturing or the automobile industry to uphold our commitment to excellence.Key Responsibilities:Ensuring the quality of raw materials received and monitoring in-process production to maintain compliance with defined...

  • Quality Assurance Professional

    1 day ago

    Jodhpur, Rajasthan, India beBeeExpert Full time ₹ 20,00,000 - ₹ 25,00,000

    **Quality Assurance Expert**We are seeking a highly skilled Quality Assurance Expert to join our team. The ideal candidate will have a strong background in software testing and quality assurance, with experience in executing test plans, monitoring code quality metrics, and conducting release readiness reviews.Key Responsibilities:Develop and execute test...

  • Quality Assurance Professional

    4 days ago

    Jodhpur, Rajasthan, India beBeeQuality Full time ₹ 6,00,000 - ₹ 11,20,000

    About Our Quality Assurance RoleWe are looking for a meticulous and results-driven Quality Assurance Specialist, who can ensure the highest standards of quality in our products.Our ideal candidate is someone with excellent analytical skills, attention to detail, and a passion for improving processes.Responsibilities● Develop and maintain quality control...

  • Precision Manufacturing Specialist

    14 hours ago

    Jodhpur, Rajasthan, India beBeeQuality Full time ₹ 1,00,00,000 - ₹ 1,50,00,000

    Quality Assurance SpecialistA career opportunity exists for a skilled Quality Assurance Specialist to ensure high-precision components meet rigorous industry standards.Our company is seeking an experienced professional with 6-8 years of experience in precision manufacturing or defence/aerospace components to join our team as a Quality Assurance...