679 Fda Jobs - Page 14

Required Skills and Qualifications: Collect and maintain hashtag#structureddata from global hashtag#regulatoryauthorities (e.g., hashtag#EMA , hashtag#FDA , hashtag#TGA ), hashtag#HTA agencies (e.g., hashtag#NICE , hashtag#HAS , hashtag#CADTH ) and pricing bodies (e.g., hashtag#DMD , hashtag#CODAGE , hashtag#PBS ) • Masters degree in hashtag#pharmacy . • Strong interest or foundational knowledge in hashtag#pharmaceuticaldrug development, hashtag#regulatory affairs, or hashtag#clinical trials. • Excellent attention to detail and ability to work with hashtag#structured data sets . • Proficiency in using hashtag#MS Excel , hashtag#Word , and hashtag#basic data tools.

Job Description : Senior IT Project Manager (Windchill 13 Upgrade) About the Role We are seeking a Senior IT Project Manager with strong expertise in PLM (Product Lifecycle Management), particularly PTC Windchill, to lead a major global Windchill v13 Upgrade Project. This is a strategic program within the healthcare and life sciences industry, with high visibility and impact. Key Responsibilities Lead the planning and execution of a Windchill v13 upgrade, ensuring business continuity, platform modernization, and compliance with regulatory requirements. Develop detailed project plans and implementation schedules, incorporating PMBOK standards and stakeholder requirements. Manage change contro...

Warm Greetings from SP Staffing!! Role: JDEdwards Consultant Experience Required :1 to 6 yrs Work Location :Pan India Required Skills : JDE Technical Interested candidates can send resumes to nandhini.s@spstaffing.in

Warm Greetings from SP Staffing!! Role: JDEdwards Consultant Experience Required :1 to 6 yrs Work Location :Pan India Required Skills : CNC Admin Interested candidates can send resumes to nandhini.s@spstaffing.in

Warm Greetings from SP Staffing!! Role: JDEdwards Consultant Experience Required :1 to 6 yrs Work Location :Pan India Required Skills : Technical Consultant CNC Consultant Finance Consultant Sales & Distribution Interested candidates can send resumes to nandhini.s@spstaffing.in

Principal Engineer (Medtech) About the Role We are seeking a highly experienced Principal Engineer to join our MedTech engineering team.The ideal candidate will bring deep expertise in Cloud, Video technologies, and Edge AI to design and deliver innovative healthcare solutions. This role requires strong technical leadership, hands-on engineering skills, and a proven background in the MedTech domain. Key Responsibilities Lead architecture, design, and implementation of MedTech solutions using Cloud, Video, and Edge AI technologies. Partner with cross-functional teams (Product, Research, and Engineering) to deliver scalable, secure, and compliant healthcare applications. Drive innovation in co...

At EY, you will 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 yourself. And EY is counting on your unique voice and perspective to help them become even better. Join EY and build an exceptional experience for yourself, contributing to creating a better working world for all. As part of the EY- Technology Risk team, you will contribute technically to IT Risk and Assurance client engagements and internal projects. You will actively establish, maintain, and strengthen internal and external relationships. Identifying potential business opportunities for Ernst & Young within existing engageme...

As a Project Engineer specializing in pharmaceutical machinery manufacturing at CoralPT Worldwide Pvt. Ltd., located in Ankleshwar, Gujarat, you will play a crucial role in managing projects from inception to completion with a focus on quality, efficiency, and adherence to industry standards. Your expertise in Blenders, Stainless steel reactors, fluid bed dryers, RMG/HSMG, Tray dryers, and other pharmaceutical equipment will be instrumental in ensuring the successful design, development, and execution of projects related to pharmaceutical machinery. Your key responsibilities will include overseeing the installation, commissioning, and validation of equipment, collaborating with cross-functio...

We are seeking an experienced and detail-oriented Medical Reviewer to join our team. The role involves reviewing, analyzing, and ensuring accuracy, consistency, and compliance of medical and scientific content in alignment with regulatory, clinical, and organizational standards. Key Responsibilities Review medical, clinical, and regulatory documents for scientific accuracy, clarity, grammar, and compliance. Ensure consistency of terminology, data, and style across all documents. Validate clinical and safety data in reports and submissions against source documents. Collaborate with cross-functional teams including medical writers, clinical research, and regulatory affairs. Provide feedback an...

Were Hiring | Sr. Executive – New Product Development at Rage Coffee At Rage Coffee, we’re not just building products—we’re creating experiences for coffee lovers across the world. Our mission is to redefine how people consume coffee by blending innovation, quality, and creativity into every sip. Now, we’re looking for a passionate Sr. Executive – Product Development to join our team and help us take our product journey to the next level. Location: Gurugram Experience: 4–8 years What you’ll be doing: *Lead and execute new product development projects from ideation to launch *Partner with cross-functional teams—marketing, operations, supply chain, and sales—to bring innovative concepts to lif...

International Solar Alliance is looking for REGULATORY SPECIALIST to join our dynamic team and embark on a rewarding career journey Diagnosing and treating illnesses, medical conditions, and injuries. Ordering, performing, and interpreting diagnostic tests. Collecting, recording, and maintaining patients' information and histories. Prescribing and administering treatments, therapies, medications, vaccinations, and other specialized medical care. Explaining procedures and discussing test results or prescribed treatments with patients and family members. Monitoring patients' conditions and progress. Directing, coordinating, consulting with, and referring patients to nurses, students, assistant...

Warm Greetings from SP Staffing Services Pvt Ltd!!!! Experience Required: 1 to 8 Years Location: Pune/Mumbai/Hyderabad Employment Type: Full-Time Job Description: Hands-on experience in JD Edwards EnterpriseOne technical development. Strong command over JDE toolsets: FDA, RDA, UBE, BSFN, NER, BSSV, and Orchestrator. Experience in Object Management Workbench (OMW) and Change Management. Good understanding of table structures, data dictionaries, and interdependencies in JDE. Knowledge of SQL, PL/SQL, and JD Edwards database structure. Exposure to CNC concepts is a plus. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Design, develop, test, and im...

You are invited to join a German Based MNC in Bangalore as a Validation Engineer with a focus on Installation and Qualification of Pharma Machinery. This exciting opportunity requires 3-6 years of experience, offering a competitive CTC of 6-8 LPA. The location for this role is Hebbal, Bangalore, and candidates must be open to both domestic and international travel. Your responsibilities will include ensuring that qualification projects meet customer requirements, clarifying customer qualification needs during kick-off meetings, and documenting agreements in the Qualification Master Plan (QMP). Additionally, you will moderate and document risk analyses, create various test documents, conduct ...

As a Clinical Data Management (CDM) professional, you will be responsible for overseeing the full lifecycle of clinical data management processes. Your role will involve ensuring the quality and integrity of clinical trial data, developing and implementing data management plans, and monitoring data entry and validation processes. You will coordinate with clinical teams to ensure timely data collection and conduct data cleaning and review activities. Additionally, you will be preparing data for statistical analysis and reporting while ensuring compliance with regulatory requirements and industry standards. Participating in protocol development and study design, utilizing data management softw...

The primary responsibilities of this role include ensuring the quality of all incoming PM, RM, in-process materials, stability samples, and finished products. You will be responsible for sampling and testing all PM, RM, in-process materials, and finished products within the specified lead time. Additionally, you will be expected to prepare testing reports in a timely manner and ensure correct labeling on materials such as sampled, approved, and rejected. You will also be responsible for sampling and testing raw water and purified water as per specifications. Other responsibilities include checking the dye strength of stock color solutions, verifying preservative traces in equipment used for ...

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...

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)...

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...

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...

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...

Chief Manager Training Centre (MP 25/14) 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/Lea...

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...

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...

Job Title: Biostatistical Programmer (SDTM & ADaM) Experience: 5+ years Employment Type: Full-time Location: Hyderabad/Bangalore/Delhi/remote Industry: Pharmaceuticals / Clinical Research / CRO Functional Area: Biostatistics / Programming / Clinical Data Management About the Role We are seeking a skilled Biostatistical Programmer with 57 years of experience and strong expertise in CDISC standards (SDTM & ADaM) . This role involves developing, validating, and maintaining datasets and statistical outputs to support clinical trial submissions. You will work closely with biostatisticians, data managers, and clinical teams to ensure high-quality deliverables aligned with global regulatory require...

Job Description Pharma Regulatory Affairs Manager Location: Pune, Maharashtra Department: Regulatory Affairs Reports To: Head – Regulatory Affairs / Senior Leadership Job Overview We are seeking a highly skilled and experienced Pharma Regulatory Affairs Manager to ensure compliance with global regulatory requirements and to support the successful development, approval, and commercialization of pharmaceutical products. The ideal candidate will bring deep expertise in regulatory affairs, strong leadership in navigating complex regulatory landscapes, and the ability to collaborate effectively with internal teams and regulatory authorities. Key Responsibilities Develop and implement regulatory s...