- Manage and review expedited adverse events, product quality complaints, and medical information to the required standard, ensuring submission to clients and regulatory agencies (if applicable) within agreed timelines.
- Assist in conducting process reviews for assigned processes and monitor audit readiness.
- Support the design and tracking of training schedules and preparation of training materials for new hires and existing team members.
- Contribute to discussion forums on quality errors within assigned projects and help identify process improvement opportunities.
- Coordinate client or external audits of assigned projects as requested.
- Assist in developing the Quality Management Plan for assigned projects.
- Collaborate with project teams to support clients during regulatory inspections at client sites, with guidance from the Quality Lead/Manager.
- Perform data analysis and, if required, suggest and implement process improvement strategies.
- Review data analysis performed by others and provide input to drive strategies for process excellence.
- Respond to or review medical information queries, product quality complaints, and general inquiries received via telephone, email, fax, etc.
- Review recorded information from multiple communication channels to ensure accuracy and compliance.
- Execute drug safety data management processes, including call intake review, call documentation review, and case follow-up.
- Guide safety associates in managing voice calls as required.
- Perform support activities such as tracking various types of information and metrics, ongoing quality control of defined process steps, training, and reconciliation of data from multiple sources.
- Review a sample of various safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging Reports, Investigator Brochures, and relevant sections of protocols and Clinical Study Reports.
- Undertake any other duties as assigned, ensuring compliance and operational efficiency.
-
The Specialist (Stability Coordinator) is an individual contributor role focuses on supporting global External Entities (EE) release and stability program operations. · ...
Pune, Maharashtra4 weeks ago
-
The Quality Specialist-Design Validation drives the complete lifecycle of medical devices from concept to commercialization by executing design control activities, driving design changes and overseeing validation processes. This role ensures compliance with quality and regulatory ...
Pune, Maharashtra2 weeks ago
-
Our company is looking for a Technical Editor to be a part of our Quality Management Systems team. · ...
Pune Full time1 month ago
-
The role is to support global External Entities release and stability program operations ensuring compliance in testing and storage of company products. · ,Compile and analyze stability data for integrated product stability programs. · ,Prepare stability-related regulatory docume ...
Pune City4 weeks ago
-
Quality specialist with good experience in quality management systems and process improvement. · ...
Pune, Maharashtra4 weeks ago
-
We are currently looking for Data Quality Specialist to join a fast growing product based Organisation in Pune. · If you are someone having strong experience and hands-on experience with data quality tools such as SAP Information Steward, Informatica DQ, Talend, Ataccama, · or eq ...
Pune, Maharashtra2 weeks ago
-
We are currently looking for Data Quality Specialist to join a fast growing product based Organisation in Pune. · If you are someone having strong experience and hands-on experience with data quality tools such as SAP Information Steward, Informatica DQ, Talend, Ataccama, or equ ...
Pune1 month ago
-
We are looking for a highly skilled Quality Analysis Specialist to join our team at BMW Techworks India Private Limited. · Bachelor's degree in a relevant field such as engineering or business administration. · ...
Pune1 month ago
-
The Product Quality Specialist role will ensure TraceLink s life sciences applications comply with global regulations and standards. · Review product test plans and approve software versions for release to customers. · Verify Installation Qualification (IQ) for deployments follow ...
Pune1 month ago
-
We are seeking a meticulous Quality Control Specialist to ensure accuracy clarity and consistency across our client deliverables. · Non-linguistic Translation Quality Review: Perform final checks on translation deliverables ensuring adherence to glossaries reference files and cli ...
Pune, Maharashtra1 month ago
-
We are seeking a meticulous Quality Control (QC) Specialist to be the final eye for accuracy, · clarity and consistency across our client deliverables.Perform final non-linguistic checks on translation deliverables. · Rigorous quality control checks for additional deliverables. · ...
Pune, Maharashtra1 month ago
-
What awaits you/ Job Profile · At BMWTechWorks India within the Cluster Digital Product Engineering, you will play a crucial role in ensuring the highest quality standards in vehicle development. You will be responsible for the execution, organization, coordination, and moderati ...
Pune, Maharashtra, India $370,000 - $650,000 (USD) per year12 hours ago
-
QA Tester (Quality Engineer) with 5–7 Years of experience required for software applications testing. · ...
Pune, Maharashtra2 weeks ago
-
We are looking for a detail-oriented Manual QA Tester with up to 3 years of experience in testing web and mobile applications. Key Responsibilities: Analyse business and functional requirements to understand application behaviour Design write and execute test cases test scenarios ...
Pune, Maharashtra2 weeks ago
-
This is an overview of the quality assurance specialist job. · ...
Pune, Maharashtra1 month ago
-
The Product Quality Specialist role within the Regulatory and Quality Compliance (RQC) department will work to ensure that TraceLink's life sciences applications and service offerings comply with applicable global regulations and standards. · ...
Pune/Pimpri-Chinchwad Area1 month ago
-
The Quality Analyst is a trainee professional role that requires good knowledge of processes and systems. · Keeps abreast of best practices in Quality Assurance. · Evaluates subordinates' performance and makes recommendations for pay increases... · ...
Pune, Maharashtra1 month ago
-
Zasya is celebrated for its commitment to delivering quality services and innovative solutions. As a comprehensive consulting agency, we specialize in providing premium enterprise services to address diverse challenges. · ...
Pune, Maharashtra1 month ago
-
We are seeking a QA hands-on lead with strong leadership, good-to-have cybersecurity exposure, and a modern, · AI-aware mindset toward quality engineering.Define and own the QA strategy and process maturity across product releases. · Collaborate with Development leads, the Produc ...
Pune, Maharashtra1 week ago
-
Zasya is celebrated for its commitment to delivering quality services and innovative solutions. · ...
Pune City1 month ago
-
Senior Specialist Quality Assurance1Experience: 12-15 Years in the role of SQA, SEPG and Metrics Function · Skills: Expert knowledge of CMMI SVC & DEV, ISO 20K and ISO 27K, ISMS, PIMS, HIPAA, Software Quality Assurance, Process Improvement & Definition, Data Privacy - GDPR & Six ...
Pune, Maharashtra ₹600,000 - ₹1,500,000 (INR) per year3 days ago
Functional Quality Specialist I - Pune - Thepharmadaily
Description
Key Responsibilities
-
Specialist, Quality
Only for registered members Pune, Maharashtra
-
Quality Specialist
Only for registered members Pune, Maharashtra
-
Specialist Quality
Full time Only for registered members Pune
-
Specialist, Quality
Only for registered members Pune City
-
Quality Specialist
Only for registered members Pune, Maharashtra
-
Data Quality Specialist
Only for registered members Pune, Maharashtra
-
Data Quality Specialist
Only for registered members Pune
-
Quality Analysis Specialist
Only for registered members Pune
-
Quality Systems Specialist
Only for registered members Pune
-
Quality Control Specialist
Only for registered members Pune, Maharashtra
-
Quality Control Specialist
Only for registered members Pune, Maharashtra
-
Quality Analysis Specialist
Only for registered members Pune, Maharashtra, India
-
Quality Assurance Specialist
Only for registered members Pune, Maharashtra
-
Quality Assurance Specialist
Only for registered members Pune, Maharashtra
-
Quality Assurance Specialist
Only for registered members Pune, Maharashtra
-
Quality Systems Specialist
Only for registered members Pune/Pimpri-Chinchwad Area
-
Quality Assurance Specialist
Only for registered members Pune, Maharashtra
-
Quality Assurance Specialist
Only for registered members Pune, Maharashtra
-
Quality Assurance Specialist
Only for registered members Pune, Maharashtra
-
Quality Assurance Specialist
Only for registered members Pune City
-
Senior Specialist Quality Assurance
Only for registered members Pune, Maharashtra
