933 Usfda Jobs - Page 12

Role & responsibilities 1. Product Registration & Certification - Support in preparing the documentation or dossier as applicable for the product registration and the certifications. - Update the documents, for response to queries and other requirements as required by respective regulatory authorities in a stipulated time frame. 2. Regulatory Audits -Internal and External Audit - Provide assistance in Internal & External audits. - Draft, Internal audit reports and coordinate with auditors for the closure of audits in a timely manner - Assist with follow-up audits, as required. 3. QMS-Maintenance - Compile and maintain regulatory documentation databases as per ISO 13485:2016 and other applica...

Regulatory Affairs Associate Responsible for preparation, review & submission of regulatory documents (US FDA, EMA, ICH), ensuring compliance with guidelines, supporting product approvals, maintaining records & coordinating with authorities. Required Candidate profile BSC/MSC/B.Pharm or Life Sciences graduate with knowledge of regulatory guidelines, dossier prep, submission processes, documentation, compliance, MS Office, attention to detail & communication skills.

Handle the Recovered Section. Assist in investigations related to out-of-specification (OOS), deviations, and laboratory incidents. Review and verify entries in logbooks, worksheets, and other controlled documents. Required Candidate profile Review analytical raw data, calculations, and reports for accuracy, completeness, and compliance with approved specifications and methods. Ensure all laboratory documentation meets regulatory

Job Title: Head Engineering & Maintenance Location: Vapi Number of positions : 1 Reporting To: Sr. VP Operations Department: Engineering & Maintenance Purpose of the Role To provide strategic leadership and operational excellence in managing plant engineering, utilities, and maintenance to support uninterrupted, compliant, and efficient API manufacturing operations. The role combines strategic engineering initiatives (capex, regulatory readiness, energy optimization) with maintenance operations (equipment reliability, preventive maintenance, troubleshooting), ensuring cGMP compliance and readiness for regulated markets. Accountability Tracks 1. Strategic Engineering Develop and execute engin...

Ensure daily production plans Vs actuals, ensure RM, PM and other material availability in accordance with the production schedule Manage and evaluate machine resources to ensure productivity and minimum downtime Provide motivation, support and guidance to all employees Recommend process improvements to enhance production quality and productivity and Provide job training to meet production goals Investigate problems, analyze root causes and define resolutions Ensure that final product meets quality standards and customer specifications Batch Manufacturing Liquid Injection Handling of Manufacturing Area BMR handling, & Monitoring and control of batch wise yield Strict follow up of GMP, cGMP, ...

We are seeking a highly experienced and driven Global Process Owner to lead the transformation of our Order to Cash (O2C) processes within our finance and accounting function. The successful candidate will be responsible for driving the analysis, design, and implementation of process improvements across multiple business divisions and regions, including the Americas, EMEA, and APAC. This role requires a strong leader who can influence, and impact work delivered from multiple centers across US and Chennai, India, and collaborate with multiple senior stakeholders at the client end. Lead the transformation of the O2C process, focusing on optimizing efficiency, reducing costs, and enhancing cust...

Ensure procurement of various key regulatory components (e.g. ordering certificates, GMP, registration samples, COA s and other regulatory documents as per the needed) to achieve marketing authorization and life cycle maintenance in collaboration with following internal and external stakeholders: NTO, Reg CMC, Global labelling & RA Ops for renewals SCM, Tech Ops for Regulatory samples, HA such as USFDA, Swiss medic/EMA & Consular Services for certificates etc, External Service providers Support for planning and management of timely delivery of critical regulatory materials (registration samples) and various regulatory authorized documents (certificates) for product license renewals, manufact...

Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications....

Roles and Responsibilities Lead and manage CAPA process from initiation to closure. Coordinate root cause investigations and ensure robust corrective actions. Track and report CAPA metrics and trends to management. Drive quality improvement projects and cross-functional collaboration. Ensure timely documentation and regulatory compliance. Facilitate audits and provide CAPA-related evidence. Support risk management and preventive action initiatives. Qualifications Bachelor’s degree in Engineering, Mechanical or related field. 7+ years’ experience in Quality/Regulatory in the medical device industry. Strong knowledge of ISO 13485, 21 CFR 820, EU MDR, and risk management (ISO 14971). Project ma...

Role & responsibilities You will lead the regulatory activities for all Convatec products including product registration (new, renewal and amendment), product promotional activities, labeling review activities, product registration and listing database. Location: Gurgaon Key duties and responsibilities Develop regulatory strategy and update the strategy based upon regulatory changes and business needs. Manage and execute regulatory compliance activities as required by the local regulations Compile, prepare, review and submit regulatory submissions to the local health authorities as well as to identify issues early in the submission preparation process that could impact product launch Monitor...

Why join AliveCor ? At AliveCor, we imagine a healthier world powered by access to personalised intelligent information. Were on a mission to be the world s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical ECG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, millions of users have taken more than 200 million heart health measurements and counting. Our vibrant team of people are attracted to AliveCor because they want to build something meaningful -- and AliveCor delivers: every day, customers tell us that ...

JD. * Lead IT strategy & operations: infrastructure, servers, Oracle ERP/NetSuite. * Ensure GMP pro custamization,compliance: systems, audits, security, cybersecurity. * Manage LIMS installation, SER, PRODUCT serialization: GMP adherence. Health insurance Employee state insurance Maternity policy Performance bonus Gratuity Provident fund Maternity leaves Paternity leaves Office cab/shuttle Annual bonus

Heres how youll contribute: Writing skills, specifically around describing a scene and driving logic Fluent in English language, familiarity with road signs in the US (Other regions including EU is a bonus) AV labeling experience (bounding boxes, etc) College Educated

Support group reporting team in loading data onto HFM from onestream. Clearing validations at HFM / OS Preparation of control sheet OS to HFM walk on monthly basis Assistance during H1 / Annual group audit / FC1 and budget submission Migration of onestream to SAP etc. Requirements: Candidate must be pursuing CA course and eligible for industrial training as per ICAI internship guidelines Good exposure in accounting, taxation, financial analysis, and statutory audits during articleship period Strong understanding of IND-AS, Companies Act, and other relevant accounting standards Advanced proficiency in MS Excel (including financial modeling, pivot tables, VLOOKUP)

Your Role Take overall responsibility and project manage the implementation of travel products for clients. Document and track projects using client-specific processes and tools. Act as the single point of contact for the project team throughout the implementation process. Ensure adherence to the client-defined onboarding process, from pre-assessment to post-implementation. Lead local Joint Planning meetings and ensure effective collaboration. Clarify and communicate roles and responsibilities to all project members. Lead weekly conference calls, prepare agendas, and produce detailed call notes. Monitor project progress, ensure timely completion of tasks, and update project tracking tools (e...

Role & responsibilities Preparation of CTD/ACTD & Country specific Dossiers Handling queries obtained from different regulatory agencies and customers across the world. Compilation, preparation and review of Technical Package of APIs. Compliance to audits of regulatory bodies especially USFDA and EU. Generation of documents from, Production, QC and QA of newly developed products Responsible for record keeping and to ensure correctness of records pertaining to department. • Knowledge of ICH Guidelines to prepare documents accordingly Lead, coordinate, write, critically review and provide strategic input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary document...

/ Responsibilities Designing of HVAC Systems & Clean Room for Pharmaceutical (Sterile/non sterile, inject able, tablet, capsule, Betalactum, liquid mfg. plants), Biotech Projects, (as per the GMP, WHO, US-FDA, ASHRAE, SMACANA, etc guidelines. Heat load Calculations and HVAC Equipments selections like chillers, cooling towers, AHU, chilled water control accessories Etc. Detailing and review of various HVAC drawing like Air flow diagram, Pr. Zoning, system zoning, equipment zoning layouts, Ducting layouts, RCP layouts, CHW & HW P&ID, HVAC Piping layouts etc. . Designing of clean rooms as per class 1,00,000 class 10,000, class 1000. Etc. knowledge of Modular partitions & False ceiling etc. Prep...

As a Senior Officer in Manufacturing at our company, you will play a crucial role in our Manufacturing team, focusing on executing complex production activities, providing technical guidance, ensuring compliance, and supporting the team lead in achieving production goals. Your strong foundation in pharmaceutical unit operations and problem-solving skills will be key in maintaining quality systems. **Key Responsibilities:** - Lead and execute manufacturing processes efficiently including Granulation, Compression, Coating, Filling, Lyophilization, Packaging. - Provide on-floor guidance, supervision, and training to officers & operators. - Review and verify GMP documentation such as BMR, Logboo...

Title: Senior Executive/ Manager - Corporate Quality Compliance Business Unit: Global Quality and Compliance Job Grade: G10 Location: Vadodara Key Responsibilities At Sun Pharma, we commit to helping you “ Create your own sunshine ”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” ...

Job Title Sr.Manager Warehouse Business Unit Sun Global Operations Job Grade G9B Location : Guwahati At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other's journeys. Key Responsibilities Ensure compliance to regulatory requirements like cGMP,...

Role & responsibilities Post - Sr Quality / QMS Engineer -Frozen Foods Location - Pune Jejuri Experience -05-08 yrs skills - QMS , Frozen Foods Contact - 9356395439 Email - jobpune22@gmail.com

Role & responsibilities Post - Sr Quality / QMS Engineer -Frozen Foods Location - Pune Jejuri Experience -05-08 yrs skills - QMS , Frozen Foods Contact - 9356395439 Email - jobpune22@gmail.com

Job Title: Calibration & Validation Trainer Pharma Industry Location: Remote Job type: Part-time Job Summary: We are seeking an experienced Calibration & Validation Trainer with 10+ years of expertise in pharmaceutical quality systems, equipment calibration, and validation practices . The role involves delivering high-impact training programs to professionals and fresh graduates, focusing on regulatory compliance, instrumentation, validation protocols, and audit readiness . The trainer will act as both a technical instructor and career enabler , ensuring participants gain hands-on knowledge aligned with industry standards (FDA, cGMP, ISO, ICH, GAMP5, 21 CFR Part 11). Key Responsibilities: De...

Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Scienc...

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Affairs 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 - Regulatory, helping the world s leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, co...