669 Fda Jobs - Page 4

Position Title: JD Edwards Technical Consultant Experience : 7 - 10 Years Location : Pan india Job Summary We are seeking a highly skilled JD Edwards Technical Consultant with extensive experience in JD Edwards EnterpriseOne 9.x or above implementations and upgrades. The ideal candidate will have a strong background in technical development, customization, data conversion, and interface development using JD Edwards tools and frameworks. This role requires a proactive consultant who can collaborate with functional teams, manage multiple workstreams, and ensure successful project delivery within defined timelines. Key Responsibilities Lead and support JD Edwards EnterpriseOne 9.x or above impl...

Job Title Manager - Plant Engineering, Pharma Formulations Plant Maintenance Pharma Formulations Basic & Minimum Qualification Degree in Mechanical Engineering from a reputed university . Experience 12 to 15 years of working experience in a Pharmaceutical Formulations plant. Location: Ankleshwar Site. Job Description And KEY ACCOUNTABILITIES Engineering & Maintenance Operations Oversee preventive, predictive, and breakdown maintenance of plant equipment and infrastructure. Ensure optimal performance of manufacturing & packing, and warehouse equipment. Lead root cause analysis and corrective actions for equipment failures. Documentation and maintaining the History cards of all critical plant ...

The ideal candidate brings 15-20 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Plan resources, ensure statutory compliance, drive traini...

The ideal candidate brings 5 to 10 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Additional info: Key Skills: DMF Compilation, QA Coordinat...

Micro Head based in Kathua, Jammu & Kashmir. The ideal candidate brings 12 - 15 yrs exp. and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Lead mi...

Assistant Manager / Sr. Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5 to 10 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improveme...

Chemist (On Contract) (MP 25/20) based in Narmada, Gujarat. The ideal candidate brings 15-20 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen...

HVAC & Water System Engineers 2 Posts based in Amritsar. The ideal candidate brings 2 - 4 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen)...

Autocad Operator 1 Pos based in Amritsar. The ideal candidate brings 6-7 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Operate and tro...

Develop and maintain V&V strategy, plans, and protocols for ventilator systems in compliance with regulatory and quality standards. Define test methodologies for system-level, subsystem-level

•8-12 years of experience in medical device development, with at least 2 years in a product ownership or leadership role. o FDA 21 CFR Part 820.30 (Design Controls) o ISO 13485 (Quality Management Systems) o ISO 14971 o IEC 62304 o IEC 60601

• Design of respiratory therapy devices, including hardware, firmware, and software integration. o DFMEA o Product risk analysis o Risk mitigations o FDA 21 CFR Part 820.30 o ISO 13485 o IEC 60601 series o ISO 14971

As a healthcare professional in this role, you will be responsible for providing care to patients while ensuring compliance with standards. Your primary focus will be on recognizing patient needs and aligning them with physician directives. Key Responsibilities: - Assure quality care in accordance with physician-set standards - Educate patients on care procedures either in person or via phone communication - Maintain compliance with guidelines from OSHA, FDA, and HIPAA throughout processes Qualifications: - Registered Professional Nurse with current licensure - Certification in CPR, ACLS, and BCLS - Familiarity with OSHA, FDA, and HIPAA compliance - Ability to lift and position patients on e...

Job Summary Payroll Specialist is responsible for executing the organization's payroll activities, ensuring pay is processed on time, accurately and in compliance with government regulations. This role involves payroll, aiding in data gathering, assisting in ad hoc projects and additional payroll works when required. Job Requirements EMEA Based payroll experience is required. Payroll Processing: Work with vendor for preparation and distribution of the company's payroll, ensuring accurate and timely processing of payroll transactions including salaries, benefits, taxes, and other deductions. Compliance: Ensure compliance with as per the government legislation requirements. Stay updated on cha...

As a pharmaceutical water system operator, your role involves monitoring, operating, and maintaining water generation and distribution systems such as Purified Water (PW) and Water for Injection (WFI). Your key responsibilities will include: - Conducting daily parameter monitoring of the water systems - Performing regular system checks to ensure proper functioning - Ensuring compliance with strict quality and regulatory standards such as cGMP, FDA, etc. - Maintaining accurate records of system operations - Troubleshooting any issues that may arise - Supporting audits to demonstrate compliance with regulations Qualifications required for this position: - Prior experience in operating and main...

Role Overview: As a Regulatory Specialist II at Velocity Clinical Research, you will be supporting a team in the preparation and maintenance of complete and accurate regulatory documents essential for clinical research studies. Your role will involve leading a team of regulatory specialists and clinical research coordinators to ensure timely and compliant regulatory submissions, as well as maintaining study binders and coordinating with auditors. Key Responsibilities: - Lead a team of regulatory specialists and/or clinical research coordinators to support Velocity Clinical - Prepare study-specific protocol, informed consent form, HIPAA authorization, and other related documents for IRB revie...

As an Executive/ Sr. Executive in Quality Management System (Analytical Assurance), your role will involve leading the Out of Specification investigations and managing core QMS activities related to QC. Your responsibilities will include: - Triggering out of specification investigations when test results fall outside predefined specifications. You will be required to design and conduct tests to confirm or eliminate suspected root causes. - Handling QMS documents such as Incidents & Deviations. - Evaluating change control & CAPA processes. - Reviewing analytical documents like worksheets, specifications, methods of analysis, stability protocols & summary reports, and logbooks from the Quality...

Role & responsibilities 1.Candidate will be based at Head Office and support business by providing Medical Support handling all Medico Marketing activities for reputed Pharma Company Supporting Multiple Divisions heading Domestic and ROW Market based at Mumbai HQ. 2. Candidate will be responsible for Multiple Divisions medically in all activities. 3. Candidate will be handle head Medico Marketing, Medical Services, Medical Training, all kind of Medical inputs and continuing Medical Education (CME) materials in compliance with relevant industry codes and medical correctness. 4.Candidate will be dealing with FDA, DCGI 5.Candidate will be closely working with all Divisional Heads & Marketing Te...

As a strategic procurement professional at Naari Pharma, you will play a crucial role in end-to-end sourcing of APIs, intermediates, excipients, and packaging materials. Your responsibilities will include managing material procurement, developing sourcing strategies, budgeting, cost optimization, supplier management, and supporting new product development initiatives. Key Responsibilities: - Manage material procurement including APIs, intermediates, excipients, and packaging for commercial & development use. - Develop and execute sourcing strategies aligned with quality, regulatory, and financial goals. - Identify alternate/secondary sources, and manage the vendor life cycle across global an...

Role & responsibilities * Prepare and Review SOPs and Guideline for DQA. * Formulate Documentation Process for the Key divisions of SRD and ARD. * Review documents with respect to drug substance such as protocols, SOPs, test methods, data COAs and report through collaborate with CRD, ARD, and QC scientists. * Successfully manage and complete all Audits that come up from time to time and conduct periodic internal audits and ensure compliance as per regulatory requirements * Review process development documents including KSM/KRM identification, specification proposal, analytical method development and validation reports, stability protocols& reports and safety studies. * Handle Vendor Qualific...

Role Overview: You will be joining ValGenesis, the market leader in end-to-end digital validation, as a Lead Validation Engineer in Chennai. Your main responsibility will be to ensure that the cutting-edge products meet the highest quality standards through validation processes. Key Responsibilities: - Collaborate with Product, Engineering, and Testing teams to understand product functionalities thoroughly. - Review Product Requirements such as Epics, User Stories, and Software Requirements. - Develop comprehensive test cases in Operational Qualification (OQ) and Performance Qualification (PQ) protocols following guidelines. - Create realistic test cases and datasets based on real-world cust...

About The Role Skill required: KYC Screening - Sanctions Screening Designation: Regulatory Compliance Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeAbility to effectively and efficiently conduct the process of screening individuals, entities, or transactions against lists of sanctioned or restricted parties. Sanctions screening involves using specialized software, understanding relevant regulations, and...

Job Title: Regulatory Filtering Analyst Role Description Deutsche Bank (DB) Group and its staff are committed to compliance with all applicable laws and official regulations in the respective jurisdictions. Restrictive measures under sanctions and embargoes are usually implemented by means of statutory regulations. The sanctions and embargoes program is aimed to ensure that DB Group and its staff fully comply with all sanctions and embargoes regulations in force in the respective jurisdiction. For this purpose, DB established a global organization with dedicated rights and responsibilities. DBs Sanctions & Embargoes Program has been implemented globally and throughout all business divisions ...

Handling Customer Complaints, Change Control, Deviation, CAPA, Customer Audit / Visit, Product re-call, Leading the Quality team from the front, Accountable for QA/QMS/QC & Micro complete operations etc. Working knowledge of IPQA & Clients SOP & QMS

Company Name Gm Agro and Beverages Job Title Principal Scientist Job Location: Harihara, Davangere, Karnataka Description GM Agro and Beverages (India) Pvt. Ltd was founded in the year 2014 by GM Group of Companies. GM Group is a company with a vast ventures in the field of Agriculture, Education, Trading, Sugar Industries, Export, Software, Real Estate, Renewable Energy Production etc. Now has stepped into the food and beverages industry. The company benefits from its previous expertise and guidance and it relies on a highly experienced and well qualified professional management team for its day to day operations. The company has setup fully Automated Manufacturing Plant which produces 7000...