669 Fda Jobs - Page 9

As a Junior Consultant in our team, your role will involve assisting Senior Consultants in conducting pharma-focused secret shopping assignments. You will be responsible for simulating real-world transactions, including prescription verification, OTC purchases, and pharmacist consultation. It will be crucial for you to document findings with evidence such as screenshots, notes, and test transactions. Your support in compliance reporting and risk analysis will be instrumental, ensuring that data handling aligns with HIPAA and GDPR privacy requirements. Your attention to detail is vital in maintaining accuracy and integrity in documenting pharmacy compliance findings. Your qualifications shoul...

Key Responsibilities : 1. Compliance and Documentation: Ensure all procurement activities comply with GMP, regulatory requirements, and company policies. Maintain accurate records of purchases, contracts, and supplier agreements. Liaise with The Home Office and obtain Import/Export licenses as required Ensure Home Office reporting is up to date with imports/Exports procured. 2. Supplier Approval: Follow the company's Standard Operating Procedures (SOPs) to execute supply chain approvals as requested by the Head of Cannabis Procurement 3. Cross-functional Collaboration: Work closely with the Directors, Head of Cannabis Procurement, Production, quality assurance, Pharmacy and CS teams to contr...

We are currently seeking a Consumables Engineer for the design of single-use products. ETO service (Engineering to Order) allows our customers to benefit from Sartorius's consumable products perfectly adapted to their bioprocess need through a detailed customization. Work With Us - Your Responsibilities Manage ETO projects in an international environment from definition to final approval Coordinate all activities for the project and create the final design and pricing Define specifications in cooperation with other departments like product development, quality, procurement, MSAT,sales and marketing for more complex projects Making technical and feasibility analyzes of projects Design new cus...

Job Title: QMS Specialist # Salary: As per Industry Standards (Depend on Experience/Knowledge) # Job Summary: We are seeking a highly skilled and experienced QMS Specialist to join our team in the plastic molding industry. The successful candidate will be responsible for implementing, maintaining, and continuously improving our QMS, ensuring compliance with international standards and regulations. # Key Responsibilities: 1. Develop, implement, and maintain QMS in accordance with international standards (e.g., ISO 9001, IATF 16949). 2. Ensure compliance with regulatory requirements, industry standards, and customer-specific requirements. 3. Conduct internal audits to ensure the effectiveness ...

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: QMS Specialist # Salary: As per Industry Standards (Depend on Experience/Knowledge) # Job Summary: We are seeking a highly skilled and experienced QMS Specialist to join our team in the plastic molding industry. The successful candidate will be responsible for implementing, maintaining, and continuously improving our QMS, ensuring compliance with international standards and regulations. # Key Responsibilities: 1. Develop, implement, and maintain QMS in accordance with international standards (e.g., ISO 9001, IATF 16949). 2. Ensure compliance with regulatory requirements, industry standards, and customer-specific requirements. 3. Conduct internal audits to ensure the effectiveness ...

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

Concept Medical is a leading developer and manufacturer of innovative medical devices specializing in interventional cardiology and radiology. Your role as a Regulatory Specialist will involve ensuring that our products comply with both local and international regulatory standards such as CDSCO, ISO, and FDA. Your expertise will be crucial in maintaining the highest levels of safety and efficacy for our stents and balloon catheters. Key Responsibilities: - Develop regulatory strategies for new and existing products to meet compliance requirements. - Ensure adherence to local and international regulations including CDSCO, ISO, and FDA. - Prepare and submit regulatory documentation and filings...

Job Description: As a member of the team, you will be assisting Senior Consultants in conducting pharma-focused secret shopping assignments. Your responsibilities will include simulating real-world transactions such as prescription verification, OTC purchases, and pharmacist consultation. It will be essential to document your findings with evidence like screenshots, notes, and test transactions. Additionally, you will support compliance reporting and risk analysis, ensuring that data handling aligns with HIPAA and GDPR privacy requirements. Your role will require maintaining accuracy and integrity in documenting pharmacy compliance findings. Key Responsibilities: - Assist Senior Consultants ...

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...

This role is part of R&D (Research & Development) focusing on Software Verification & Validation (V&V) for healthcare/medical/pharma-related systems. Key Responsibilities Perform software verification & validation to ensure compliance with medical device/healthcare software standards. Develop, execute, and automate test cases, scripts, and frameworks. Work on test planning, defect tracking, debugging, and quality assurance activities. Collaborate with cross-functional teams R&D, product engineering, and regulatory teams. Ensure compliance with ISO 13485, IEC 62304, FDA guidelines (typical in medical software). Skills & Requirements Strong background in manual + automation testing for softwar...

Candidate should technically sound for assigned profile- Candiadte should have regulatory exposure in previous organisation

R&D Manager The Indus Valley Location : Chennai - Perungudi| Function : Research & Development | Experience : 8 15 years Our Mission Infuse every kitchen with goodness, ensuring the safety and health of our customers and their families. Our Vision Transform 100 million Indian households into safe havens of health with our exceptional products. At The Indus Valley, we are more than just a cookware brand we are on a mission to make Indian kitchens healthier and safer, one product at a time. If you're passionate about innovation, consumer wellbeing, and hands-on product development, join us in shaping the next generation of kitchen essentials. Role Overview We are looking for a dynamic and hand...

Assist clients and their digital marketing team in providing clients with strategic guidance as it relates to all aspects of automotive digital marketing site Meets with stakeholders and gathers business end-user requirements and uses this data to define and develop technical specifications and processes for design, coding and testing. Your primary responsibilities include: Installation, configuration and maintenance of JD Edwards EnterpriseOne environments including tools releases, ESUs, ASUs, and application updates. Manage CNC architecture, including path codes, environments, data sources, and object configurations. Administer JDE WebLogic, HTML servers, AIS servers, BSSV, and Orchestrato...

As an Upstream Manufacturing Documentation at Syngene, your role will involve leading the upstream process group to design and develop cell culture processes for monoclonal antibody and fusion protein production. You will provide expert leadership overseeing strategic and day-to-day activities in upstream process development of complex novel biologics. Your responsibilities will include overseeing technology transfer to support scale-up and GMP manufacturing, building strong relationships with CMOs, designing and executing risk-based process characterization studies, scaling up processes, preparing technology transfer protocols, collaborating with other teams, liaising with regulatory affair...

As a Quality Assurance Coordinator, you will play a crucial role in ensuring the quality standards of the products by implementing and monitoring quality assurance policies and procedures. Your responsibilities will include: - Assisting in planning and implementing quality assurance policies and procedures. - Monitoring and analyzing quality performance metrics to identify trends and areas for improvement. - Supervising quality control operations, including inspections, audits, and testing procedures. - Working closely with production, R&D, and supply chain teams to resolve quality-related issues. - Leading root cause analysis (RCA) and corrective/preventive action (CAPA) initiatives. - Coor...

As a Consultant with at least 10 years of IT experience, your recent focus should have been around J.D. Edwards EnterpriseOne, preferably version 9.1. Your expertise lies in technical development tools for customization, retrofit, data conversion, and interface development using OMW, RDA, TDA, FDA, Visual Compare, FRW, TCs, BI Publisher BSFN and BSSV, Orchestrator, and Groovy Scripts. Having experience in these areas will be an added advantage for you. Your role will require you to have a minimum of one full-cycle implementation or upgrade experience of EnterpriseOne. You should have played a significant role in one of the technical streams of a Global JD Edwards project. Your responsibiliti...

Experience At least 10 years IT experience with recent focus around J.D. Edwards EnterpriseOne (preferably 9.1 version) in technical development tools for customization, retrofit, data conversion and interface development OMW, RDA, TDA, FDA, Visual Compare, FRW, TCs, BI Publisher BSFN and BSSV, Orchestrator, Groovy Scripts, will be an added advantage. Role Consultant should have a minimum of one full-cycle implementation or upgrade experience of EnterpriseOne, he/she should have played a sizeable role in one of the technical streams of Global JD Edwards project along with : Proven experience and understanding of various JD Edwards technology options around customization, retrofit, data conve...

Regulatory Affairs professional with knowledge of D&C Act, Rules, and FSSAI regulations. Experienced in Domestic Market only.

Food Mfg Co req QA. Male. M.Sc./M.Tech. Food Technology/Microbiology. 3-5 Yrs exp. Develop, implement QMS. Monitor food Production, R&D. Expert in ISO QMS, GMP, FSSC 22000, FDA, FSSAI. Inspect, Test, Audit, Document & Report. CQA, HACCP certified. Required Candidate profile Male. PG in Food Tech/Microbiology/Chemistry. 3-5 Yrs exp as QA in Food Mfg Co. Work @ Chennai. Expert in QMS, Food Quality & Safety Stds. Build QMS & team. Good employee benefit, increment, promotion Perks and benefits PF, Insurance, Increment, Promotion Paid Leave etc

Role & responsibilities Job Title Manufacturing Engineer/Process Validation Engineer Location – Chennai Delivery looking immediate joiner only Conduct detailed gap assessments of current manufacturing practices against applicable medical regulatory standards (e.g., FDA, ISO 13485, EU MDR, GMP). Review process controls, equipment validation, and quality systems documentation to identify non-compliances and areas for improvement. Identify systemic issues and risk areas related to manufacturing quality, process robustness, and compliance. Support remediation activities including process updates, validation efforts, documentation revisions, and training plans. Strong understanding of regulatory ...

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: 1.Electrical Design:...

As a healthcare professional in this role, your primary responsibility will be to provide quality care to patients while ensuring compliance with set standards. You will need to have a keen understanding of patient needs and be able to prioritize them alongside the directives provided by physicians. Your key responsibilities will include: - Assuring quality care by following the standards established by physicians - Educating patients on care procedures either in person or via phone communication - Adhering to compliance guidelines, including those set by OSHA, FDA, and HIPAA The qualifications required for this position are as follows: - Registered Professional Nurse with a valid license - ...

We are looking for a skilled professional with 6 to 11 years of experience in Object Management Workbench Development to join our team in Hyderabad. The ideal candidate will have expertise in designing, developing, and maintaining JD Edwards objects. Roles and Responsibility Design, develop, and maintain JD Edwards, BSSV, BSFN, or regular JDE objects. Develop E1 pages, Orchestration, and JDE API integration solutions. Collaborate with cross-functional teams to identify and prioritize project requirements. Troubleshoot and resolve technical issues related to JD Edwards objects. Participate in code reviews and ensure high-quality deliverables. Stay updated with the latest trends and technologi...

We are looking for a skilled Process Validation Engineer to join our team in Pune. The ideal candidate will have 3-10 years of experience in process validation and quality systems, with a strong background in regulatory compliance and hands-on experience in manufacturing activities. Roles and Responsibility Perform gap assessments and conduct remediation of documents with stakeholder inputs. Develop and maintain Manufacturing/Service Work Instructions and related documents. Create/modify process flows within the Manufacturing/Service Departments. Support the development and introduction of new products, processes, and technologies, focusing on quality systems. Monitor and drive corrective ac...