669 Fda Jobs - Page 3

8 years experiences for RA role in medical device and or pharmaceutical industry.Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements. Required Candidate profile Desired Skills:RA role in medical device, US FDA and EU. Bachelor degree in Medical, Mechanical, Electric Life Science or other healthcare related majors.

Procurement Operations: Source and procure raw materials (APIs, excipients), packaging materials, and other pharma-related items. Evaluate purchase requisitions and coordinate with internal departments (production, QA/QC, R&D) to ensure timely procurement. Issue purchase orders (POs) and track their status until delivery and GRN. Vendor Management: Identify, evaluate, and develop new suppliers and maintain strong supplier relationships. Negotiate prices, payment terms, delivery schedules, and contracts. Monitor vendor performance based on quality, cost, delivery, and service. Inventory & Cost Control: Coordinate with the inventory team to maintain optimum stock levels. Analyze and control pr...

About The Role Project Role : Business Analyst Project Role Description : Analyze an organization and design its processes and systems, assessing the business model and its integration with technology. Assess current state, identify customer requirements, and define the future state and/or business solution. Research, gather and synthesize information. Must have skills : Business Requirements Analysis, Pharmacovigilance & Drug Safety Surveillance, Life sciences Business Analyst Good to have skills : NA Minimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Business Analyst, you will analyze an organization and design its processes a...

Develop high-quality regulatory documents, including clinical trial applications and marketing authorizations.Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Required Candidate profile Minimum 2 years of experience in regulatory medical writing or a related field. Strong knowledge of regulatory requirements, including FDA, EMA, and ICH guidelines.

Develop high-quality regulatory documents, including clinical trial applications and marketing authorizations.Collaborate with cross-functional teams to ensure compliance with regulatory requirements Required Candidate profile Minimum 2 years of experience in regulatory writing, preferably in the pharmaceutical or healthcare industry. Strong understanding of regulatory requirements, including FDA, EMA, and ICH guidelines.

Develop high-quality regulatory documents, including clinical trial applications and marketing authorizations.Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Required Candidate profile Minimum 2 years of experience in regulatory writing, preferably in the pharmaceutical or biotechnology industry. Strong knowledge of regulatory requirements, including FDA, EMA, and ICH guidelines.

Develop high-quality regulatory documents, including clinical trial applications and marketing authorizations. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Required Candidate profile Minimum 2 years of experience in regulatory writing, preferably in the pharmaceutical or biotechnology industry. Strong understanding of regulatory requirements,

JD @ QC Executive will ensure that products meet quality standards & regulatory requirements with analyzing samples, conducting tests, maintaining documentation & more. Accommodation, Meals & Transport from company side Saturdays are Half day

Coordinate regulatory submissions and ensure compliance with relevant laws and regulations. Prepare and review regulatory documents, including applications and reports. Collaborate with cross-functional teams to meet regulatory requirements. Required Candidate profile Strong knowledge of employment firms and recruitment services. Excellent communication and coordination skills. Ability to work effectively in a fast-paced environment. Strong analytical skills.

Conduct thorough analysis of clinical trial data to identify potential safety concerns. Develop and implement effective safety protocols to mitigate risks associated with medical devices. Collaborate with cross-functional teams Required Candidate profile Strong understanding of clinical trials, medical devices, and regulatory requirements. Excellent analytical and problem-solving skills. Ability to work effectively in a fast-paced environment.

We are seeking a highly skilled and motivated Process Engineer to join our team at Morepen Laboratories Ltd, a leading organization dealing in manufacturing of home diagnostics medical devices. The Process Engineer will play a crucial role in optimizing manufacturing processes, ensuring product quality, and driving continuous improvement initiatives. This role requires a strong understanding of manufacturing principles, medical device regulations, and process improvement methodologies. Role & responsibilities Process Optimization: * Analyze and optimize manufacturing processes to improve efficiency, reduce costs, and enhance product quality. * Develop, implement, and validate process improve...

Preferred candidate profile Qualifications/ JD: Bachelor's degree in Mechanical / Biomedical / SW /HW Engineering, Quality Assurance, Regulatory Affairs, or a related field. In-depth understanding of medical device regulations, including FDA 21 CFR Part 820.30 and ISO 13485:2016 requirements for design controls and DHF. Experience with risk management principles (e.g., ISO 14971) and their application to DHF. Experience with DHF remediation projects, especially for legacy products and/or in response to regulatory changes. Experience with Quality Management Systems (QMS) software and tools for DHF management (e.g., TcU, SAP PLM) is a plus.

Key Responsibilities: • Develop and align quality strategies across plant locations ensuring compliance and product consistency. • Oversee QA/QC with adherence to GMP and global regulatory requirements. • Lead audits, inspections, and regulatory interactions. • Drive continuous improvement using Six Sigma, Lean, and other QMS frameworks. • Build and mentor strong quality teams across sites. • Track and analyze Quality KPIs (FPY, supplier defects, COPQ, regulatory observations). • Collaborate with Plant Heads, Production, R&D, Supply Chain, and Regulatory Affairs for synchronized quality efforts. Required Qualifications: • Bachelor’s/Master’s in Pharmacy, Chemistry, Engineering, or related sc...

This is an exciting role and would entail you to • Oversee the end-to-end submission process of materials to the MLR review platform (Veeva Vault Promo Mats) • Understand and document client-mandated submission requirements and ensure these protocols are maintained with guidance from MLR/Submission managers • Create, uphold, and maintain submission checklists for assigned brands and ensure accurate and timely MLR submissions into Client systems • Maintain a comprehensive and accurate record of all current and upcoming submissions including the stage of review, job codes, references, and deadlines • Annotate any notes/comments relevant to MLR reviewers onto the submission file (As required, f...

We are looking for a skilled JDE Technical Consultant with 7-11 years of experience to join our team in India. The ideal candidate will have a strong background in technical consulting and expertise in JDE systems. Roles and Responsibility Collaborate with clients to understand their business requirements and provide tailored solutions using JDE systems. Design, implement, and maintain complex JDE applications, ensuring seamless integration with existing systems. Troubleshoot and resolve technical issues related to JDE systems, providing timely and effective solutions. Develop and deliver training programs to end-users on JDE systems, ensuring successful adoption and utilization. Work closel...

Role & responsibilities Support on IT quality systems framework design and implementation Managing the reviews and assessments for IT quality Assist in Computer System Validation (CSV) compliance of GxP processes for pharmaceutical companies or experience on quality compliance services for global consumer health care, medical devices, and pharmaceutical companies GxP Business process review Development of integrated GxP and IT compliance Standard operating procedures and guidelines GxP and IT compliance assessment Define the Validation strategy of IT Software and Systems Actively participate in the Validation Life Cycle of regulated IT projects or platforms by planning validation deliverable...

Experienced Validation Engineer with expertise in Computer System Validation (CSV), Lab Systems, Quality, and Compliance. Responsible for validating LES, ELN, QMS, and ensuring GxP compliance in pharma or life science environments.

He is responsible for implementing and maintaining quality systems to ensure manufacturing processes and products meet regulatory standards like cGMP and ICH guidelines, reviewing & approving documentation such as batch records and SOPs. Required Candidate profile cGMP and ICH guidelines, reviewing & approving documentation such as batch records and SOPs, supporting internal and external audits, participating in process equipment validation. manage deviations Perks and benefits SALARY WITH PF, ESIC, BONUS ,GRATUTITY BENEFITS

Company Name Haldiram Job Title Senior Executive Job Location: Nagpur Description Making India's Favorite Snacks Since 1937 Over the course of eight decades, a lot has changed about us. We have relocated, undergone expansion, developed new product lines & added segments, opened retail chain of stores across India and embraced new markets overseas. One thing hasn't changed we're still a tight-knit family business, committed to serving the most authentic taste of India through our products. Our origins can be traced back to a small namkeen shop in Bikaner founded by Ganga Bishan Agarwal (Haldiram Ji). This modest shop quickly gained popularity and scaled up to meet a booming demand for its uni...

Job Description Knowledge and Skills a. Knowledge Good working knowledge of medical device regulations and practices (ISO 13485, FDA QSR, etc.). Practical and demonstrated experience of Quality or Reliability engineering, risk analysis, product development and verification/validation testing in the medical device industry. Demonstrated hands-on experience with Design Control procedures. Experience in a Phase-Gate development process. Experience in directly applying statistical methods for quality improvement. Good knowledge and understanding of process development, total quality tools, and continual improvement approaches. b. Skills Good technical writing skills. Familiarity with statistical...

KnJ Projects Private Limited is looking for Material cum Quality Expert to join our dynamic team and embark on a rewarding career journey. Develop and implement quality assurance policies and procedures. Conduct quality audits and inspections. Analyze data to identify areas for improvement. Provide training on quality standards and processes. Ensure compliance with regulatory requirements. Disclaimer : This job description has been sourced from a public domain and may have been modified by Naukri. com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

Description Medical Writer II (CSR Narratives) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers,...

Job Title: Manager - Regulatory Affairs / Quality Assurance Company: GreenSignal Bio Pharma Pvt Ltd Location: Gummidipoondi, Chennai, Tamil Nadu Experience: 10-15 years in Quality Assurance and Regulatory Affairs, specifically within the Vaccine, Injectable, and Sterile Industry Educational Qualification: Bachelors or Masters in Pharmacy M.Sc in Biotechnology, Microbiology, or a related field Additional qualifications in life sciences or pharmaceutical sciences are a plus Job Overview: As the Manager QA / Regulatory Affairs , you will play a pivotal role in ensuring that our vaccine , injectable , and sterile pharmaceutical products meet global regulatory requirements and quality assurance (...

1. Regulatory Submissions & Approvals: Prepare, review, and submit drug regulatory dossiers (e.g., Formulations, APIs, supplements) to CDSCO, state FDA, and other authorities . Follow up on approval status, queries, and responses with regulatory bodies. Maintain trackers of pending applications, renewal dates, and approvals . 2. Documentation & Compliance: Ensure preparation of regulatory documents, SOPs, product labeling, packaging inserts, and promotional materials in compliance with regulatory norms. Maintain accurate records of regulatory correspondence, approvals, and submissions . Support internal audits and inspections with regulatory documentation. 3. Product Lifecycle Management: Mo...

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...