
Clinical Quality Assurance Compliance Position
21 hours ago
Clinical Quality Assurance Compliance Officer
This role involves overseeing end-to-end clinical trial activities from a quality perspective. The incumbent will be accountable for ensuring that all teams, including Clinical Trial Medical Science and Operations, Clinical Trial Supply Management, and Clinical Data Management, adhere to applicable regulations and guidelines.
Key responsibilities include:
- Developing and implementing a risk-based approach to quality compliance within the function, which ensures trial participants and data are safeguarded in accordance with regulatory requirements and best practices.
- Identifying team member's job-specific SOP training requirements and maintaining oversight of training to ensure all team members are trained on each SOP as required.
- Preparing SOPs related to QC functions and supporting the review of SOPs specific to Medical science, Clinical team, and Data Management team.
- Quality reviewing clinical trial medical science-related activities such as Synopsis, Protocol, Clinical Study Report (CSR), and appendices, and SOPs in line with ICH GCP requirements, Indian, and global regulatory requirements.
- Quality reviewing clinical trial operation-related activities, related tools, plans, and documentation like site feasibility, site selection visit, site initiation, Ethic committee documentation, monitoring – site-specific reports, Site Documents, logs, and close-out activities in line with ICH GCP requirements, Indian, and global regulatory requirements.
Required Skills and Qualifications:
- 5 years' experience in a CRO/Pharma/Biotech organization in the Quality department with experience in Quality activities in Clinical Research departments.
- Strong attention to detail and ability to spot inconsistencies are essential, along with good conflict management skills.
- Must have experience handling audits and inspections by DCGI and US FDA.
- Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations, and other applicable regulations pertaining to clinical trials.
- Experience working in matrix business environments is preferred.
- Strong track record of success demonstrated through annual performance ratings and/or professional accomplishments and awards.
-
Senior Quality Assurance Professional
6 days ago
Kottayam, Kerala, India beBeeQuality Full time ₹ 15,00,000 - ₹ 22,50,000Job Opportunity:We are currently seeking a skilled professional to fill the position of Quality Assurance Specialist. The ideal candidate will possess strong expertise in quality assurance principles and practices, with a focus on ensuring compliance with Good Clinical Practice (GCP) guidelines.The selected individual will play a crucial role in supporting...
-
Pharmaceutical Quality Assurance Specialist
4 days ago
Kottayam, Kerala, India beBeePharmaceutical Full time ₹ 20,00,000 - ₹ 25,00,000Job Title:Quality Assurance Executive">About the Role:This is a full-time, on-site position for a Quality Assurance Professional. The successful candidate will be responsible for daily quality control and assurance activities, ensuring compliance with relevant standards and regulations.The role involves conducting quality audits, managing quality...
-
Quality Assurance Specialist
19 hours ago
Kottayam, Kerala, India beBeeQuality Full time ₹ 12,00,000 - ₹ 15,00,000Job Title: Quality Assurance Specialist">The Role of Quality Assurance Specialist is pivotal in driving the DevSecOps department forward, ensuring the execution, support, and continuous improvement of quality assurance processes. This position focuses on test planning, code quality enforcement, vulnerability scanning, and release readiness to guarantee...
-
Quality Assurance Specialist
21 hours ago
Kottayam, Kerala, India beBeeQuality Full time ₹ 8,00,000 - ₹ 12,00,000Job DescriptionWe are seeking a skilled Quality Assurance Specialist to join our team and play a key role in upholding and enhancing world-class quality standards.The ideal candidate will be responsible for conducting incoming, in-process, and final inspections, managing and resolving customer complaints through root cause analysis and corrective actions,...
-
Senior Quality Assurance Expert
1 week ago
Kottayam, Kerala, India beBeeQualityAssurance Full time ₹ 12,00,000 - ₹ 15,00,000Quality Assurance Specialist Role:About the Position:Our organization seeks a diligent Quality Assurance Specialist to contribute to ensuring the high quality of our products through comprehensive testing and quality control.Primary responsibilities include executing manual and automation testing, developing test cases, plans, and scripts to guarantee...
-
Senior Biostatistician
3 weeks ago
Kottayam, Kerala, India Advanced Clinical Full timeThe Senior Biostatistician is responsible for leading, developing, implementing, and overseeing statistical strategies and deliverables in support of the Client's R&D sponsored clinical trials. Under the guidance of Head of Biostatistics, this role contributes to the planning, execution and interpretation of statistical analyses across development programs,...
-
Senior Biostatistician
2 weeks ago
Kottayam, Kerala, India Advanced Clinical Full timeThe Senior Biostatistician is responsible for leading, developing, implementing, and overseeing statistical strategies and deliverables in support of the Client's R&D sponsored clinical trials. Under the guidance of Head of Biostatistics, this role contributes to the planning, execution and interpretation of statistical analyses across development programs,...
-
Quality Compliance Officer
1 week ago
Kottayam, Kerala, India beBeeCompliance Full time ₹ 40,00,000 - ₹ 50,00,000Job Overview:Quality Assurance Compliance SpecialistThis position is responsible for ensuring compliance with regulatory requirements and quality management system standards. The ideal candidate will have a strong background in validation methodologies, analytical and problem-solving skills, and effective communication abilities.Key Responsibilities:Prepare...
-
Quality Compliance Specialist
1 week ago
Kottayam, Kerala, India beBeeAnalytical Full time ₹ 4,00,000 - ₹ 5,00,000Quality Assurance Associate Job SummaryThe Quality Assurance Associate plays a crucial role in ensuring quality standards and accuracy in compliance with predefined checklists. This position requires collaboration with the team to execute daily responsibilities effectively.Collaborate with onshore and offshore teams to ensure quality compliances and...
-
Senior Quality Assurance Specialist
21 hours ago
Kottayam, Kerala, India beBeeProductivity Full time ₹ 15,00,000 - ₹ 20,00,000Quality Assurance LeadWe are seeking a highly skilled Quality Assurance Lead to oversee daily quality assurance operations and develop/implement quality management systems. The ideal candidate will ensure compliance with industry standards, lead continuous improvement initiatives, manage quality audits, produce quality reports, collaborate with...