934 Usfda Jobs - Page 31

Position Assistant Manager-QA Function QA Location Bharuch;;;;;;; Reports to Head QA Summary of Job (Purpose/ objective of the job Department organogram to be enclosed) To check the Quality Assurance of the products and ensure compliance with the SOP's. Key Responsibilities (Performance Indicators) Quality professional of progressive experience with strong knowledge of Speciality Ingredient, Bulk Chemicals, Food additive/ Food supplement and API Manufacturing, Quality Management System (QMS), Qualification, Validation and other Manufacturing functions.; Documentation and Handling i.e.: Integrated Management System (IMS) (ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018), WHO-GMP, FSMS (ISO 2...

Hiring QA & RA with an leading IVD Company in Hyderabad Exp: 6+ Yrs in QA & RA, ISO 13485 Mandatory Stability & immediate joiner with Biotech background Candidate With medical Device background can apply share resume at sarika.bhandari@acumont.com

Head of Engineering & Maintenance- will lead all engineering and maintenance operations for a large-scale API pharmaceutical plant. This role is responsible for ensuring the optimal performance, reliability, and compliance of plant equipment, systems, and facilities. The position requires extensive experience in API manufacturing, including expertise in CGMP, FDA regulations, and managing regulatory audits. Develop and execute maintenance strategies, drive continuous improvement, manage OPEX budgets, and lead a high-performing team to ensure safe, efficient, and compliant plant operations. LOCATION: Digwal, Hyderabad REPORTING STRUCTURE: Reports to Global Engineering & Project head & Site he...

Job Description Candidate should the exposure for handling the Bottle packing line. Should have the work experience in Regulatory plant. Faced the USFDA, MHRA,TGA inspection. Good Communication skill. Having the SAP knowledge. Work Experience 3 to 05 years' Experience. Education Graduation in Pharmacy Competencies

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 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 Embedding digital transformation in healthcare operati...

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 ...

The reputed pharmaceutical company engaged in development, manufacturing and marketing of oral solid dosages forms in regulated market. We are looking for competent, growth-oriented professional in Quality Assurance and Quality Control profiles for our USFDA & EU-GMP approved OSD manufacturing facility at N-32, Additional Patalganga MIDC, Tal.- Panvel, Dist.- Raigad.Roles and Responsibilities Ensure compliance with cGMP guidelines during formulation development, solid oral manufacturing, and OSD production. Conduct analytical method validation, stability studies, and quality control activities to ensure product quality. Develop and maintain documentation for batch records, test results, and ...

The reputed pharmaceutical company engaged in development, manufacturing and marketing of oral solid dosages forms in regulated market. We are looking for competent, growth-oriented professional in Quality Assurance and Quality Control profiles for our USFDA & EU-GMP approved OSD manufacturing facility at Patalganga MIDC, Tal.- Panvel, Dist.- Raigad.Roles and Responsibilities Ensure compliance with cGMP guidelines during formulation development, solid oral manufacturing, and OSD production. Conduct analytical method validation, stability studies, and quality control activities to ensure product quality. Develop and maintain documentation for batch records, test results, and equipment calibra...

The Apex Group was established in Bermuda in 2003 and is now one of the worlds largest fund administration and middle office solutions providers. Our business is unique in its ability to reach globally, service locally and provide cross-jurisdictional services. With our clients at the heart of everything we do, our hard-working team has successfully delivered on an unprecedented growth and transformation journey, and we are now represented by over circa 13,000 employees across 112 offices worldwide.Your career with us should reflect your energy and passion. Thats why, at Apex Group, we will do more than simply empower you. We will work to supercharge your unique skills and experience. Take t...

Job details: Role: Sr. Member - Corporate Quality Assurance Direct Reporting: Sr. Expert - Corporate Quality Assurance Level: MD 6 Function: Quality Location: Pune - Hinjewadi Phase 2 Job Purpose and Scope Responsible for implementing the activities for the management of CQA Accountabilities Indicator: CQP Management FSSAI Facility Licensing of Food Business in FOSCOS System. Regulatory Gap analysis and interpretation of Nutraceuticals. Regulatory Compliance for 21 CFR, FSANZ, EU, US and ROW Regulations and Standards for Food and Nutraceutical. Quality and Food Safety Key Accountabilities: Regulatory Assessment: Responsible for Regulatory Compliance check for food/ Nutraceutical industry and...

Job Description: Head of Quality Experience: 15 Years or more Location: Udaipur About Macsen Drugs: Macsen Drugs is a USFDA registered, WHO-GMP certified, TGA GMP certified, and EU GMP (Written Confirmation) certified manufacturer of active pharmaceutical ingredients or bulk drugs for varied therapeutic applications like antidote, urinary antiseptic, topical antiseptic, ophthalmic diagnostic, anti-dandruff, anti-acne, and several other applications. Job Overview: We are seeking an experienced and detail-oriented individual to perform research activities as designing and conducting scientific experiments, analyzing and interpreting results, leading to significant value to the process developm...

We are hiring for the role FSQA Specialist Roles and Responsibilities: Inspect incoming rice and other food products for quality parameters such as moisture content, foreign matter, broken grains, and discoloration . Ensure strict compliance with internal quality standards , customer specifications, and regulatory requirements (USDA, FSSAI, etc.). Monitor and maintain food safety programs including HACCP, GMP, and sanitation protocols . Review and validate supplier documents like Certificates of Analysis (COA), test reports, and compliance records. Maintain accurate quality inspection reports , non-conformance records, and documentation logs. Collaborate with procurement and supplier teams t...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years Language - Ability: English(International) - Intermediate 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...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 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 Embedding digital transformation in healthcare operati...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 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 Embedding digital transformation in healthcare operati...

Skill required: Provider Network - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 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 Embedding digital transformation in healthcare o...

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy 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 aligne...

Supriya life science ltd is looking for Manufacturing Officer to join our dynamic team and embark on a rewarding career journey. Production Management : Oversee the entire production process, including scheduling, resource allocation, and production planning. Quality Control : Implement quality control measures to ensure products meet established standards and specifications. Process Optimization : Continuously assess and improve manufacturing processes for efficiency, cost reduction, and waste minimization. Inventory Management : Manage raw materials, work - in - progress, and finished goods inventory to ensure smooth production flow and prevent shortages or overstocking. Safety Compliance ...

We are looking DM RA with leading pharma company in Thane. Experience in Injectable regulatory affairs pre approval & post approval experience is must. Regulatory Submissions New Project Assignment This role involves the assignment and management of new projects for regulatory submissions, playing a pivotal part in the preparation and timely submission of high-quality regulatory documents across the US, EU, UK, and Emerging Markets. The position demands a strong understanding of global regulatory requirements, excellent communication skills, and effective cross-functional collaboration to ensure successful outcomes. Educational Qualifications Bachelor’s or Master’s degree in Pharmacy, Chemis...

We are seeking a dynamic and experienced candidate to lead and manage the overall operations of our sterile injectable manufacturing plant. The ideal candidate will be responsible for ensuring seamless plant operations, regulatory compliance, quality standards, and people management while driving productivity and efficiency. About the Responsibilities Strategic Leadership: Lead the end-to-end operations of the sterile injectable plant, including production, quality, engineering, supply chain, and EHS functions. Regulatory Compliance: Ensure full compliance with internal and external regulatory standards (e.g., EU-GMP, WHO-GMP) and corporate SOPs. Operational Excellence: Drive continuous impr...

Job Area: Finance & Accounting Group, Finance & Accounting Group > Global Accounting Ops Center General Summary: Job Overview The EMEA Payroll Staff will support the Qualcomm EMEA Payroll function, its processes, and internal or external relationships with General Accounting, Human Resources, Legal, Benefits, Employee Relations, Stock Programs, IT, Tax Auditors, ADP, and other related entities. This position will be responsible for developing, implementing, and maintaining processes that will contribute to efficient payroll processing for 5,000+ employees across multiple EMEA countries. This position will report to the Payroll Manager, located in Hyderabad, and will be responsible for coachi...

Role & responsibilities : Act as the lead internal auditor for medical device programs, ensuring compliance with ISO 13485 and U.S./EU regulations. Investigate non-conformances and implement effective corrective actions for medical device-related issues. Review onboarding checklists to ensure FDA and EU MDR requirements are met for all devices. Oversee compliance in shipping, labeling, and depot processes for investigational and commercial devices. Serve as the main contact during ISO 13485 audits and coordinate with logistics and external auditors. Monitor regulatory changes (FDA, EMA, MDR) and update quality systems accordingly. Administer the EDMS platform, managing system operations, use...

Role & responsibilities Responsible for utilities, air conditioning, water system & maintenance of building & premises, maintenance of production, engineering equipments and QMS activities. To ensure the engineering activities such as preventive maintenance, routine & breakdown maintenance, calibration, Equipment & area validation are carried out as per the schedule. To ensure that all the subordinates are adequately trained for Job assigned. Optimum utilization of resources. To ensure that Optimum resources such as man, material & areas are available for the smooth operation of engineering related activities. To prepare Periodic assessment sheet on power and fuel and to Monitor and check th...

Role & responsibilities Responsible for utilities, air conditioning, water system & maintenance of building & premises, maintenance of production, engineering equipments and QMS activities. To ensure the engineering activities such as preventive maintenance, routine & breakdown maintenance, calibration, Equipment & area validation are carried out as per the schedule. To ensure that all the subordinates are adequately trained for Job assigned. Optimum utilization of resources. To ensure that Optimum resources such as man, material & areas are available for the smooth operation of engineering related activities. To prepare Periodic assessment sheet on power and fuel and to Monitor and check th...

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Data Review Associate in Mumbai, India to join our Global Clinical Coding & Support team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous nursing expertise and can develop and grow your career even further, then this is the opportunity for you! Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to ac...