679 Fda Jobs - Page 20

You will be working in the Operations department of Pharma Solution business located in Lexington. Your role as a Manufacturing Operator will involve performing various production activities such as component preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production. You will report directly to the Manufacturing Supervisor. Your key responsibilities will include complying with all relevant policies and procedures, performing line clearances and cleaning/sanitization, operating and maintaining production equipment, ensuring proper ingredients and quantities of batches, executing validation protocols, maintaining records, and following Good ...

Role Summary: As Deputy Manager Automation (Pharma Process Validation & Documentation) , you will lead validation strategy, customer interfacing, and cross-functional coordination to ensure seamless project execution and regulatory compliance. This role demands strong technical acumen, leadership capability, and the ability to drive results across departments in a regulated pharmaceutical environment. Key Responsibilities: Lead project documentation and automation activities, ensuring timely execution and alignment with customer requirements. Manage end-to-end coordination for CRMs and KOMs preparing agendas, driving discussions, and capturing actionable outcomes. Define and implement valida...

Medical R&D Team Lead-Chennai-10+years-NPD Job Category: TEAM LEAD Job Type: Full Time Job Location: chennai Years of Experience: 10+ years Position Overview This is an excellent opportunity to work for the global leading company in the field of gas control equipment. The focus of this role is managing our R&D team based in Chennai who are focused on Healthcare products and covering mechanical, electrical, electronics and software disciplines. Duties & Responsibilities Managing the teams actions to delivery New Product development projects. This is an end to end responsibility of successful project delivery from gate 0 to post project audit. Manage the R&D budget, timelines, and resources ef...

• Facilitate the implementation and support of SAP Public Cloud- 2 SL System and 3 SL System • Experience in Cloud Transport Management process related to FICO part • Good Knowledge in Business Process Tiles • Have good exposure of the Data Migration Cockpit • Good exposure on Banking • Bank Master Data • House Banks and Account Ids • EBS • DME • Facilitate the implementation and support of SAP Financials with expertise and focus on FICO Controlling Cost Center Accounting, Profit Center Accounting, Product Costing, Month End process and Treasury. • Expertise in Process, Configuration & Customization of SAP FICO sub-modules: FI-New GL, FI-AP, FI-AR, Asset Accounting. • Perform detailed analys...

S4HANA Finance for Group Reporting Job Description Should have experience 8-10 years end to end implementation experience of SAP S/4 HANA for Group reporting. Interactions with various client functional teams to understand the requirements and to finalize the design of each model in SAP Group reporting CA/ICWA candidates are preferred but otherwise should be a Postgraduate as minimum educational qualification like MBA / M. Com etc. SAP FICO (S/4HANA 1809 & above) experience is preferable. Good hands-on experience in AO (Analysis for Office) reports experience Balance sheet, Profit & Loss, Cash flow reports and Custom analytic queries. Should have sound knowledge/configuration experience on t...

Key Responsibilities: Greenfield S/4HANA Implementation •Lead and manage greenfield S/4HANA implementation projects within the life sciences/pharma industry. •Design and configure the SAP CO module to meet specific business requirements and regulatory standards. •Oversee system integration, testing, validation, and data migration activities. Client Interaction and Workshops : •Conduct client meetings to gather requirements, present solutions, and provide project updates. •Facilitate workshops to engage clients, understand their operational challenges, and deliver tailored solutions. •Build and maintain strong client relationships, serving as the primary point of contact throughout the projec...

Note: Qualification: B.Tech / B.E. in Biomedical Engineering, Biotechnology, or related Medical Engineering field (Pharma background (B. Pharma / M. Pharma) profiles will not be considered) Mandatory Skills: Regulatory Affairs Medical Devices EU MDR compliance Design History File (DHF) Risk Assessment & Risk Management Familiarity with ISO 13485 and other applicable standards Key Responsibilities: Prepare, review, and manage regulatory submissions for medical devices (India and international markets) Ensure compliance with EU MDR (Medical Device Regulation) and local regulatory requirements Maintain and update Design History Files (DHF) , Technical Files, and Risk Management documentation Co...

At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. As part of our EY- Technology Risk team, you'll contribute technically to IT Risk and Assurance client engagements and internal projects. An important part of your role will be to actively establish, maintain, and strengthen internal and external relationships. You'll also identify potential business opportunities for Ernst & Young within ex...

Filling & review BMRs, MFRs, SOPs, ECR Maintain records for CC, CCF Ensure documentation aligns with GMP Requirement Support audits & investigations with accurate records. Coordinate with production & QA for data verification. Required Candidate profile Must Require Knowledge for filling & Review of BMR BMR, CC, CCF, and OOS handling Documentation practices & regulatory understanding Good communication & MS Office proficiency

The role of Calibration Technician/Engineer involves carrying out calibration activities at various sites across India and abroad. Your main duties will include executing calibration tasks for a range of equipment including computerized systems, plant equipment, laboratory equipment, facilities, utilities, and process control systems. These calibrations will be conducted to support GMP/FDA requirements for our clients. The ideal candidate for this position should have prior experience in providing calibration services. The job is based in Vasai, with travel required to different locations for on-site calibration work. As a Calibration Technician/Engineer, you will play a crucial role in ensu...

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...

Purpose of the role: The Design Quality Engineer will be responsible for ensuring the design, development, and manufacturing processes comply with regulatory requirements, industry standards, and company quality policies. This role will involve close collaboration with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Quality Assurance. Roles & Responsibilities: Ensure design control activities comply with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485) and standards (e.g., ISO 14971, IEC 62366). Participate in design reviews and provide quality engineering support throughout the product development lifecycle. Establish and maintain Design History Fil...

Regulatory Affairs Executive ( for Cosmetic Industry ) Kheda, Gujarat 3–5 Years Experience CTC up to 6 LPA Strong knowledge of global cosmetic regulations (EU/USA/ASEAN/Gulf) Expertise in labeling, claims review, and documentation

Role & responsibilities Analyze U.S. generic market opportunities using IQVIA, FDA databases, Orange Book, and competitive intelligence tools Identify and prioritize products based on market size, competitive landscape, development feasibility, and potential profitability Conduct patent, exclusivity, and litigation analysis (Paragraph IV, FTF opportunities) Work closely with R&D, Regulatory, Legal, and Supply Chain to ensure selected products align with internal capabilities Track product development pipeline and communicate risks or bottlenecks Prepare business cases and forecasting models for executive decision-making Preferred candidate profile: Bachelor's or Masters in Pharmacy, Life Sci...

Role & responsibilities: Experience with REST Assured API, SOAP UI automation testing. Develop, maintain, and execute automated test scripts with web applications. Collaborate with development, QA, and DevOps teams to ensure the highest quality of software releases. Work closely with cross-functional teams to understand business requirements and translate them into test scenarios. Define, Identify and implement best practices for test automation processes and tools. Analyze and interpret test results, report defects, and ensure issues are resolved. Generate detailed test reports and metrics to track testing progress and effectiveness. Mentor and train junior team members on test automation p...

We at SUN PHARMA are hiring for 'Manager- New Product Launch ' role. Sun Pharma is the No. 1 and largest pharmaceutical company in India with over 8% market share in the domestic market (AIOCD AWACS for 12 months ending Sept 2023). The company has been ranked No. 1 with over 12 different classes of doctors (SMSRC Prescription Data). Sun Pharmas branded generics business in India commands leading position in high-growth chronic therapies and strong positioning in the acute segment. Job Summary: The position will be responsible for the planning, monitoring, execution and risk management for launch of new pharmaceutical products. This role involves coordinating with cross-functional teams ensur...

Industry: Payments/ Financial Services business Functional Area: Payments and Financial Services Role: Senior Manager Reporting to :Director Legal Key Skills: Drafting, vetting, and negotiating agreements, Providing legaladvice, Product counselling, Interpreting regulations and providing guidance to internal teams, Risk identification and Management. Experience: Minimum 10+years experience, including experience inPayments/ FinancialServices/ FinTech (required). Education University Degree in law. A Masters Degree in Law is not mandatory, but will be an added advantage. Location: Bangalore PRIMARY RESPONSIBILITIES : Business Reviewing existing products, as well as new products/ features, with...

Educational Bachelor of Engineering,BTech,Master Of Engineering,MTech 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 your teams tow...

Key Responsibilities: Quality Systems Management: Implement and maintain Good Manufacturing Practices (GMP) in compliance with regulatory requirements (e.g., WHO, USFDA, MHRA). Ensure all processes and systems meet regulatory, corporate, and client quality standards. Manage and monitor the quality management system (QMS), including change control, deviations, CAPA, and risk assessments. Documentation & Compliance: Prepare, review, and update Standard Operating Procedures (SOPs) and quality assurance policies. Conduct internal audits and coordinate external audits and regulatory inspections. Maintain and ensure timely submission of quality documentation, including batch records, validation pr...

Preparation, compilation, and review of dossiers for USFDA and ROW markets ANDAs, amendments, and deficiency responses for the USFDA. Strategize, plan, and oversee USFDA submissions – ANDA, PAS, Annual Reports, and post-approval changes.

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 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 Science...

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 3 to 5 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 ...

Job Description Overall Single Point of Contact for Quality IT Projects (such as LIMS, Chromatography, QAMS, EDMS, LMS etc.) Finalization of URS in alignment with sites (India + Global). Harmonization of system and processes in line with regulatory requirements and compliances. Testing and Validation of IT applications in line with URS for QA/ QC/ Common applications. Keeping organization up to date on the requirement for smart QA/ QC. Defining SOP and training of personnel. Supporting operational team. Keeping senior management updated on the organization status. Keeping senior management updated on the organization status. Facing Regulatory Audits at site as and when required. Keeping site...

Role & responsibilities Prepares the submissions (ANDAs, amendments, supplements including labeling, annual reports) to support commercial business and to be-in compliance to FDA regulations. Review CMC submission documents from regulatory perspective to meet scientific and technical requirements for acceptability and approvability by FDA. Escalate the review findings for a timely resolution. Leads labeling development for product launches and ensures that all labeling meets company and US regulating health authority specifications. Initiate/Review change control process and coordinate with other departments to ensure timely implementation. Prepare, review and submit eCTD submissions. Collab...

Skills: Technical experience with JD Edwards EnterpriseOne (8.12, 9.0, 9.1, 9.2) using the development toolsets. Need technical consultant not a functional consultant. Should have worked on at least one full cycle of JD Edwards Project implementation / Upgrade / Support with an experience in design and development of Oracle JD Edwards Enterprise One 9.1 and above, modules/suites In depth knowledge and expertise in Integration and Interops using BSSV , REST call/ Orchestrators, EDIs, Real Time Event (RTE),Batch Interface, Point to Point Integrations. Excellent business communication skills, negotiation skills, and presentation skills Expertise and hands-on of JDE ( preferably 9.2 ) technical ...