679 Fda Jobs - Page 17

Develop SOPs for production, filling, packaging & QA/QC; ensure FDA, EU, BIS & Drug Act compliance; conduct audits; review BMR, BPR & MFR; implement QMS; train staff on GMP/GLP; manage labelling, claims & documentation for regulatory compliance.

Role & responsibilities Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. Represents the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed. Monitors timelines and budgets for assigned projects and updates the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk. Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on data integrit...

Role & responsibilities Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. Represents the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed. Monitors timelines and budgets for assigned projects and updates the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk. Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on data integrit...

Responsibilities: * Ensure compliance with food safety standards during audits * Prepare accurate documentation for certifications * Conduct regular audits at edible oil facilities * Maintain BRCGS, FSSAI, FDA certifications Thanks RIGHTCHOICE

Role & responsibilities : Minimum 5 years of experience in Project Management. Must possess excellent communication skills and should be proficient in Microsoft Office. Should have prior experience in team handling. Mentors and leads less experienced medical writers on complex projects, as necessary. Acts as lead for assigned writing projects. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Compiles, writes, and edits medical writing deliverables including operating guidance documents, SOPs, training guides, etc., and serves as a medical writer within and across departments ...

Compiles, writes, edits, and coordinates medical writing deliverables that present scientific information clearly and accurately, and works as a medical writer within and across departments with minimal or moderate supervision. Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. Adheres to established regulatory standards, including, but not limited to, ICH E3 guideline...

Compiles, writes, edits, and coordinates medical writing deliverables that present scientific information clearly and accurately, and works as a medical writer within and across departments with minimal or moderate supervision. Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. Adheres to established regulatory standards, including, but not limited to, ICH E3 guideline...

Manual Testing Proven prior hands-on experience (5+ years) in testing medical device software Prior experience in Integration, Regression and System testing. Prior experience in tools like HP ALM Experience in FDA compliant test documentation. Experience in Agile development processes and methodologies. Possess sound knowledge of test methodologies. Experience is defect management tool Strong knowledge of STLC System requirement analysis Author detailed Test plan, test protocols, trace matrices and test reports Good documentation practice.

Ensure compliance with GMP & regulatory standards, oversee quality systems, audits & validations, manage QA team, review batch records, handle deviations/CAPA, support regulatory inspections, ensure product quality & safety across manufacturing.

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by c...

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...

The ideal candidate will be responsible for providing care to patients while adhering to compliance standards. You should be able to recognize patient needs and prioritize those needs with the requirements outlined by physicians. You will be responsible for assuring quality care by adhering to the standards set by the physicians. Additionally, you will provide care education to patients in person or over the phone and ensure adherence to compliance guidelines throughout processes, including OSHA, FDA, and HIPAA. To qualify for this position, you must be a Registered Professional Nurse with current licensure. Certification in CPR, ACLS, and BCLS is required. Knowledge of OSHA, FDA, and HIPAA ...

As a global leader in assurance, tax, transaction, and advisory services, EY hires and develops passionate individuals to contribute to building a better working world. The culture at EY emphasizes providing training, opportunities, and creative freedom to help individuals realize their full potential. EY focuses not only on who you are currently, but also on who you can become. The organization believes that your career is yours to shape, offering limitless potential and motivating experiences to support your professional growth. The role of Senior Consultant-National-Forensics-ASU in the Forensics - Discovery team in Hyderabad involves the following key responsibilities: - Demonstrating te...

As an Analytical Chemist at Linde South Asia Services Pvt. Ltd., your primary responsibility will be to ensure quality control and compliance with GMP regulations under FDA guidelines. You will play a crucial role in meeting targets and optimizing plant parameters to maximize output and efficiency. Your duties will involve ensuring compliance with local regulations and obtaining necessary approvals and licenses, particularly those required by the FDA. You will participate in the selection of suitable suppliers, negotiate technical solutions, and conduct stage gate inspections to maintain quality standards. Additionally, you will assess technical competencies, assign tasks accordingly, and pr...

The ideal candidate will be responsible for providing care to patients while adhering to compliance standards. You should be able to recognize patient needs and prioritize them alongside the requirements outlined by physicians. You will be responsible for assuring quality care by adhering to the standards set by the physicians. Additionally, you will provide care education to patients either in person or over the phone, and ensure compliance with guidelines throughout the processes, including OSHA, FDA, and HIPAA. As a candidate for this position, you must be a Registered Professional Nurse with current licensure. It is essential to possess CPR, ACLS, and BCLS certification, as well as have ...

The job involves preparing documentation for FDA, MDR, ISO, CE, GMP, or any other compliances as required by the company from time to time. You will be responsible for quality checking based on specific parameters and conducting factory visits for quality monitoring and execution. Additionally, you will be involved in incoming and outgoing QC validation, with a focus on ensuring compliance with quality standards. Proficiency in written and spoken English is essential for this role, along with good computer skills. Manpower management, handling stores/purchase, logistics, and new vendor development are also key responsibilities. Ideal candidates for this position should have a degree in B. Ph...

At Medtronic, you can embark on a life-long journey of exploration and innovation, all while contributing to championing healthcare access and equity for all. Your role will be pivotal as you lead with purpose, striving to break down barriers to innovation in a more connected and compassionate world. As an IT Application Business Analyst specializing in Mergers, Acquisitions, and Divestitures (MA&D), you will play a crucial part in supporting various teams and stakeholders to ensure the successful delivery of IT application initiatives within a dynamic and evolving business environment. Your responsibilities will include coordinating application-related tasks, conducting business analysis, a...

As Senior Engineer-Electrical Hardware Engineering, you will develop creative Electrical solutions to challenging problems related to new product development and sustenance engineering of Surgical Solutions and Operating Room Integration Solutions. You will be responsible for hardware and PCB design & development in New product development and sustaining engineering of surgical tables, communication gateways, Video integration solutions etc. Your team will also be responsible for sustenance activities including change control, investigations for customer complaints and project work to address field issues related electrical components/ subsystems and design changes arising from component obs...

Role Overview The Sr. Associate IS Engineer CTRS will support the Regulatory and Clinical Trial Submission (CTRS) product team by designing, developing, and maintaining software solutions to meet critical business needs. The role involves close collaboration with product managers, designers, engineers, and vendor partners, with a focus on applications like Disclose from Citeline and docuBridge Suite from Lorenz. The ideal candidate will bring hands-on technical expertise along with deep knowledge of regulatory submissions and clinical trial disclosure systems, playing a key role in maintaining application performance, compliance, and innovation. Roles & Responsibilities Design, develop, and ...

As a Data Management Specialist, you will be responsible for designing and reviewing Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems. You will develop and maintain Data Management Plans (DMPs), data validation specifications, edit checks, and coding guidelines. Your role will involve overseeing data entry, data cleaning, discrepancy management, and query resolution processes to ensure data integrity. It will be your responsibility to ensure compliance with industry standards such as CDISC (CDASH, SDTM) and regulatory guidelines from FDA and ICH-GCP. You will be involved in conducting User Acceptance Testing (UAT) of EDC systems and monitoring data quality throughout the pr...

The PV Specialist is responsible to have oversight and management of SDEAs/PVAs for Business relationships in all regions. This includes coordination with various stakeholders, business relationship assessment, SDEAs/PVAs drafting, review & revision for Dr Reddy's business relationships ensuring to meet the standard process and applicable regulatory requirements. Responsibilities: To coordinate with various stakeholders involved in Business relationship of all regions to ensure: All main agreements are assessed for PV obligations to ensure either a PV clause or a separate SDEA/PVA is required and placed Existing SDEAs/PVAs are up to date with respect to the current templates with standard pr...

Work Your Magic with us! Ready to explore, break barriers, and discover more We know youve got big plans so do we! Our colleagues across the globe love innovating with science and technology to enrich peoples lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That&aposs why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas su...

The ideal candidate will be responsible for providing care to patients while adhering to compliance standards. You should be able to recognize patient needs and prioritize those needs with the requirements outlined by physicians. Your responsibilities will include assuring quality care by following the standards set by the physicians, providing care education to patients in person or over the phone, and adhering to compliance guidelines throughout processes, such as OSHA, FDA, and HIPAA. To qualify for this role, you must be a Registered Professional Nurse with current licensure. Additionally, you should hold certifications in CPR, ACLS, and BCLS. It is essential to have knowledge of OSHA, F...

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 ...

Role & Responsibilities : We are hiring across multiple levels for our Adobe Campaign practice. Roles include : Developer (3+ yrs) : Build email templates, technical workflows, and manage configurations on Adobe Campaign Classic. Lead (5+ yrs) : Design schemas, lead integrations (CRM, DB), and ensure performance tuning and scalability. Architect (8+ yrs) : Own Adobe Campaign platform architecture, define FDA and deployment strategies, lead enterprise integrations. Common responsibilities : Collaborate with internal teams and clients. Handle requirement gathering, campaign design, and implementation. Ensure quality standards and timely delivery. Preferred Candidate Profile : 3 to 12 years of ...