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3.0 - 7.0 years
0 Lacs
hyderabad, telangana
On-site
You are a highly motivated Compliance Software Implementation Specialist with experience in healthcare regulatory standards. Your main responsibility will be to lead the implementation of compliance platforms at Ambulatory Surgery Centers (ASCs). This will include gathering requirements, configuring the software, providing end-user training, and ensuring ongoing system support. Your role will involve close coordination with clinical, IT, and administrative teams. You will be leading and managing the implementation of compliance software at ASCs, ensuring that the software meets regulatory, accreditation, and facility-specific needs. Additionally, you will be responsible for training ASC staff on system use, workflows, and compliance documentation. It is crucial to ensure adherence to regulatory standards such as CMS, AAAHC, and Joint Commission. Your role will also involve providing ongoing support, troubleshooting, and optimization of the platform, as well as coordinating with internal IT teams, ASC administrators, and super users. Documenting workflows, changes, and implementation outcomes will also be part of your responsibilities. To excel in this role, you should have experience with healthcare or compliance software, such as incident reporting, infection control, or credentialing. Familiarity with ASC regulations including CMS, AAAHC, and Joint Commission is essential. Strong project management skills and effective stakeholder communication are required. You should also be able to train both clinical and non-technical staff, demonstrate a basic technical aptitude in software configuration and system integration, and possess excellent verbal and written communication skills. Attention to detail in regulatory and documentation practices is a key attribute. The ideal candidate for this position would hold a Bachelor's degree in Nursing, Life Sciences, Healthcare Administration, Engineering, or a related field. Additional certifications in healthcare compliance or project management would be advantageous.,
Posted 2 days ago
2.0 - 6.0 years
0 Lacs
ahmedabad, gujarat
On-site
The Quality Control (QC) Reviewer plays a crucial role in ensuring the accuracy, completeness, and compliance of laboratory and clinical data with regulatory guidelines, company policies, and industry standards. Your responsibilities include reviewing raw data, study documentation, and analytical reports to ensure adherence to protocols and regulatory requirements. By identifying discrepancies and errors, you will provide recommendations for corrective actions to maintain data integrity. Collaboration with laboratory analysts, study coordinators, and quality assurance teams is essential to resolve issues related to data accuracy and compliance. As a QC Reviewer, you will document your findings meticulously, preparing detailed reports for management and regulatory bodies. Additionally, you will participate in audits and inspections to uphold quality standards. To excel in this role, you should hold a Bachelors/Masters degree in Life Sciences, Pharmacy, Chemistry, or a related field. With 2-6 years of experience in Quality Control/Quality Assurance within the pharmaceutical or biotech industry, you are expected to have a strong understanding of GLP, GCP, FDA, EMA, and ICH guidelines. Proficiency in reviewing analytical data, clinical study reports, and laboratory documentation, along with excellent attention to detail and problem-solving skills, are essential. Effective communication and interpersonal skills are necessary to collaborate with cross-functional teams. Moreover, staying updated with regulatory changes and industry best practices will contribute to enhancing the organization's quality standards. Experience with bioanalytical, clinical, or preclinical study reviews, knowledge of electronic data capture (EDC), and the ability to handle multiple projects with tight deadlines are preferred skills for this role. Proficiency in Microsoft Office and Laboratory Information Management Systems (LIMS) would be advantageous.,
Posted 1 week ago
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