669 Fda Jobs - Page 10

Support and Maintenance of customers Adobe Campaign Classic platform Responsible for handling tickets in Production environment Perform RCA on recurring issue and provide permanent fixes Monitoring of the workflow and taking corrective actions Coordination of system-related activities between user and multiple technical teams Responsible for the upkeep and maintenance of Adobe Campaign application servers and coordination with DBA"s Understanding integration of Adobe with other applications. Primary Skills 4 to 5 years of support and development experience with Adobe Campaign Classic (Neolane) Experience in working with different Adobe Campaign modules, like; Message Centre, Content Manager,...

Oversee the formulation, blending, and packaging processes in compliance with GMP and industry regulations Ensure adherence to quality control standards, safety norms, and environmental regulations Optimize resource utilization Required Candidate profile Coordinate with R&D, QA/QC, and supply chain teams for smooth product flow. Liaise with management on production planning, reporting, and audits. Maintain documentation as per regulatory guidelines.

Recorders and Medicare Systems Pvt Ltd is looking for RA Executive to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available ...

Description Regulatory Manager (CMC, EU & Japan/China) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem so...

Description Regulatory Manager (CMC, EU & Japan/China) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem so...

Warm Greetings from SP Staffing!! Role: JDEdwards Consultant Experience Required :3 to 8 yrs Work Location :Nagpur/Coimbatore Required Skills : JDE Technical Interested candidates can send resumes to nandhini.s@spstaffing.in

Warm Greetings from SP Staffing!! Role: JDEdwards Consultant Experience Required :3 to 8 yrs Work Location :Nagpur/Coimbatore/Bhubaneswar Required Skills : JDE Technical Interested candidates can send resumes to nandhini.s@spstaffing.in

Oversee the formulation, blending, and packaging processes in compliance with GMP and industry regulations Ensure adherence to quality control standards, safety norms, and environmental regulations Optimize resource utilization Required Candidate profile Coordinate with R&D, QA/QC, and supply chain teams for smooth product flow. Liaise with management on production planning, reporting, and audits. Maintain documentation as per regulatory guidelines.

Role : Senior Clinical Data Manager Location : Chennai, Tamil Nadu Experience : 10-15 Years Requirements: 10-15 years of experience in clinical trial/data management and data operations. Minimum 4-5 years of people management (preferred) experience with proven supervisory skills. Extensive experience with CTMS platforms (CRIO, RT CTMS, Veeva Vault CTMS, or similar). Strong background in EDC systems management and clinical data operations. Experience in pharmaceutical, biotechnology, or CRO environment across multiple therapeutic areas. Technical Expertise: CTMS configuration and administration skills (Having knowledge in CRIO is an advantage). Deep knowledge of EDC platforms and system integ...

We are seeking an experienced Senior Electrical Design Engineer/ manager/ Lead with 12+ years of expertise to lead the design, planning, and coordination of electrical distribution system and electrical design of services mainly in railways system including the mainline, metros, semi high speed and high speed projects. The ideal candidate will possess strong technical knowledge, exceptional problem-solving abilities, and a deep understanding of electrical design standards, codes, and best practices. This role offers the opportunity to work on large-scale, high-profile projects for India and abroad with focus on transportation sector mainly Railways. Key Responsibilities: Electrical Design: L...

Job Description: We are seeking an experienced Senior Electrical Design Engineer/ manager/ Lead with 12+ years of expertise to lead the design, planning, and coordination of electrical distribution system and electrical design of services mainly in railways system including the mainline, metros, semi high speed and high speed projects. The ideal candidate will possess strong technical knowledge, exceptional problem-solving abilities, and a deep understanding of electrical design standards, codes, and best practices. This role offers the opportunity to work on large-scale, high-profile projects for India and abroad with focus on transportation sector mainly Railways. Key Responsibilities: Ele...

We are seeking a detail-oriented and experienced Manager, Quality Assurance to lead our QA team and ensure the highest standards of quality across products, processes, and services. The QA Manager will be responsible for developing and implementing quality assurance policies, conducting audits, analyzing data, and collaborating with cross-functional teams to drive continuous improvement. Key Responsibilities: Lead and manage the Quality Assurance team, including hiring, training, and performance management. Develop, implement, and maintain QA standards and procedures in accordance with regulatory requirements and best practices. Monitor and report on quality metrics, identifying areas for im...

Job Title: Computer System Validation (CSV) Specialist Regulatory Compliance & QA Location: Hyderabad Experience: 3 to 6 Years About the Role: A leading MNC is hiring skilled Computer System Validation (CSV) Specialists to support regulatory compliance, QA, and governance for validated systems and infrastructure. Key Responsibilities: Identify/manage regulatory risks (GxP, cGMP, FDA, 21 CFR Part 11) Author validation strategies, protocols, and reports (end-to-end CSV required) Execute IQ, OQ, PQ in compliance with cGMP Work with cross-functional teams: R&D, QA, IT, Manufacturing, Engineering Validate systems in Agile SDLC environments Review validation lifecycle documentation Support Change ...

We are looking for a highly skilled Regulatory Medical Writer with 1 to 6 years of experience to join our team in Mumbai. The ideal candidate will have a strong background in regulatory affairs and medical writing, with excellent communication and analytical skills. Roles and Responsibility Develop high-quality regulatory documents, including clinical study reports, marketing authorizations, and other related materials. Collaborate with cross-functional teams, including regulatory affairs, product development, and clinical operations. Conduct thorough reviews of regulatory documents to ensure accuracy, completeness, and compliance with regulatory requirements. Stay up-to-date with changing r...

Job Description Summary As Customs & Global Trade Team Leader , you will provide detail oriented and proactive support for international trade operations. This role ensures compliance with global customs regulations and supports smooth import/export processes for pharmaceutical products. Key responsibilities will include: 1. Team Management Effective in resource management skills, ability to synthesize disparate information, and build consensus, has sound judgment and decision-making Good interpersonal, leadership, and team player skills Excellent oral, written, presentation and communication skills Quality Orientation and ability to take initiative and demonstrate ownership of problem resol...

Roles and Responsibility Develop high-quality regulatory documents, including clinical trial applications, marketing authorizations, and periodic safety update reports. Collaborate with cross-functional teams, including regulatory, clinical, and product development, to ensure compliance with regulatory requirements. Conduct thorough reviews of regulatory documents to ensure accuracy, completeness, and adherence to company standards. Stay up-to-date with changing regulatory requirements and industry trends to improve document quality and compliance. Provide training and guidance to junior writers on regulatory affairs and medical writing best practices. Participate in the development of new r...

Role & responsibilities -Handling of Pharma Instruments i.e. HPLC, GC, UV, KF, IR, etc. -SOP Preparation. -Analytical documents preparation. -Wet analysis to be performed. Preferred candidate profile -Having experience in Pharma company only. -Having experience to face regulatory & customer audits. -Having knowledge of GLP & GMP importance.

Roles and Responsibility Manage and oversee the collection, review, and reporting of clinical trial data. Ensure compliance with regulatory requirements, such as GCP and FDA guidelines. Develop and implement effective data management plans and procedures. Collaborate with cross-functional teams, including clinical operations and statistical analysis. Conduct quality control checks on data accuracy and completeness. Provide training and support to site staff on data management best practices. Job Requirements Strong knowledge of clinical study protocols, informed consent forms, and case report forms. Experience with data management systems, such as Oracle or SQL. Excellent analytical and prob...

Number of requirements 1 / Level 3 rd Experience: 6 to 7 Years Job Overview: As a SAP CRM Consultant specializing in Application Support Management, the primary responsibility will be to provide ongoing application support, maintenance, and request fulfillment enhancements for SAP CRM systems. The consultant would have to work closely with business users to understand their needs and ensure that the CRM application remains reliable, secure, and aligned with GB ( Business Unit) goals. Qualifications: Bachelor's degree in a relevant field, such as Computer Science, Information Technology, or Business. Proven experience in SAP CRM On Premise application support and management. ( 6-7 years) Stro...

Job Title: Manager / Sr. Manager Sales & Marketing (APIs) Location: Vashi, Navi Mumbai Department: Sales & Marketing Reporting To: Marketing Head About Us Calyx Chemicals & Pharmaceuticals Ltd. is a leading manufacturer and supplier of Active Pharmaceutical Ingredients (APIs). With a strong global presence and focus on innovation, we are committed to delivering high-quality pharmaceutical solutions while ensuring compliance with international standards. Key Responsibilities Develop and execute strategic sales & marketing plans to drive revenue and business growth. Identify new business opportunities in domestic & international API markets. Monitor market trends, competitor activity, and regu...

Define and implement reliability strategies and frameworks for software systems. Collaborate with cross-functional teams to integrate quality and reliability engineering throughout the SDLC. Lead risk management activities including DFMEA, hazard analysis, and traceability. Design and maintain post-market monitoring and alerting solutions to proactively address issues. Conduct root cause analysis and drive effective CAPA implementation. Develop tools and automation for reliability testing and validation. Ensure system availability through redundancy, failover, and recovery strategies. Support audits, regulatory inspections, and compliance with IEC 62304, ISO 13485, and ISO 14971. Mentor team...

As a global leader in assurance, tax, transaction, and advisory services, EY is dedicated to hiring and nurturing passionate individuals like you in an effort to contribute towards creating a better working world. Our culture is rooted in the belief that every individual deserves the training, opportunities, and creative freedom essential for growth. We are not solely interested in your current capabilities but in the potential of who you can become. Your career is yours to shape, with limitless possibilities awaiting you. Throughout your journey with us, we are committed to providing you with inspiring and fulfilling experiences that will aid you in evolving into the best version of your pr...

Educational Requirements Master Of Engineering,MTech,Bachelor of Engineering,BTech Service Line Engineering Services Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide y...

Manufacturing operations, ensuring GMP compliance and safety. Monitor Manufacturing/production, maintain batch records and SOPs, assist with audits, and drive process improvements to enhance efficiency, reduce costs, and improve product quality.

Note to Hiring Manager: In support of BNP Paribas APAC's Diversity Commitment, Hiring Managers are to consider at least 1 Asia Pacific national, 1 male and 1 female candidate for the position to be filled. Position Purpose Facilitating transaction processing of instructions received from Client to ensure all settlement of trades in Global markets. Providing round the clock service to cover client queries across ASIA, EMEA and US regions. Reconciling client positions to match with the market positions. Being a team player and a manager to achieve team co-ordination, adhere to BNP policies and follow the agreed timelines to avoid any breach in SLA. Responsibilities Job summary Roles & Responsi...