933 Usfda Jobs - Page 6

Chief Manager Township Administration (MP 25/13) 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...

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...

Sterile Manufacturing based in Waghodia, Vadodara. The ideal candidate brings 1- 7 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). Additio...

The ideal candidate brings 1-6 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) Lead microbiology practices including EM, MLT, sterility assur...

About The Role Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years Accenture is a global professional services company with leading capabilities in digital, cloud and security.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 count...

About The Role Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years Accenture is a global professional services company with leading capabilities in digital, cloud and security.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 count...

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 Plant Head / Chief Operating Officer (COO) - Oral Solid Dosage in Ahmedabad, your primary role will be to lead strategic growth, operational excellence, and regulatory compliance in a regulated industry. You will report to the Board and play a crucial part in expanding the company's market presence. **Key Responsibilities:** - Define, communicate, and implement business strategy aligned with growth goals - Oversee daily operations, drive efficiency, and ensure financial discipline - Lead regulatory, licensing, and compliance efforts (e.g. GMP, USFDA, EMA) - Build and mentor a high-performing leadership team - Act as a company spokesperson and engage with investors, regulators & Board **...

Handled ANDA submissions with thorough knowledge on review of CMC documents of dosage: Injectables (simple and complex), Ophthalmics, Topicals, Nasal Sprays and Tablets. knowledge on Module 5 requirements with review & upload study reports. Required Candidate profile Experience of eCTD tools - Educe/Lorenz and/or Pharma Ready. evaluate and respond Agency’s Deficiencies. review DMF. USFDA. Experience of handling submissions related to site transfer products

Hands-on experience in GMP-compliant manufacturing environment Exposure to regulatory audits (e.g. USFDA, MHRA, WHO). Deep understanding of GMP, ICH guidelines, and local / international regulatory requirements Skilled in preparing for and facing customer audits. Root cause analysis, CAPA implementation, and continuous improvement Familiarity with QMS software, oracle, SAP, Minitab, LIMS, and other electronic documentation systems. Involvement in quality systems: deviations, CAPA, change control, and batch release Experience in document control & validations Managing QA teams, mentoring staff, and cross-functional collaboration

1. Production Operations Plan, execute, and monitor day-to-day injectable manufacturing operations (Liquid / Lyophilized / SVP / LVP). Ensure adherence to batch manufacturing records (BMR) and standard operating procedures (SOPs). Coordinate with Planning, QA, QC, Engineering, and Stores for smooth production activities. Monitor in-process checks and ensure timely completion of batches. Ensure line clearance before starting operations. 2. Compliance & Documentation Ensure compliance with cGMP, WHO, USFDA, EU, MHRA, and other regulatory standards. Review and approve BMR, BPR, and related production documentation. Participate in internal and external audits (regulatory and customer). Initiate ...

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...

1.Role & responsibilities Preparation and review of Standard Operating Procedures. Issuance, review of OOS,OOT,Deviation,CAPA,Change Control & its Management. To impart internal trainings to DCAL Employees. Review of the Instrument qualifications and re-qualifications protocols of Quality control. Preparation & review of quality risk assessment documents. Review and approval of analytical data related to QA release. Review & Approval of Specification STP, Raw data sheet etc. To review laboratory investigations related to complaints and deviations and to ensure CAPA related to QC are completed within timeline. Internal Audit and External audit Compliance To support RA for analytical assistanc...

Roles and Responsibility Develop and implement operational strategies to achieve business objectives. Manage and supervise a team of professionals to ensure efficient operations. Analyze operational data to identify areas for improvement and optimize processes. Collaborate with cross-functional teams to align with organizational goals. Ensure compliance with regulatory requirements and industry standards. Foster a culture of continuous improvement and excellence within the team. Job Requirements Proven experience in operations management with a minimum of 8 years of experience. Strong leadership and management skills, with the ability to motivate and inspire teams. Excellent analytical and p...

Roles and Responsibility Develop and implement operational strategies to achieve business objectives. Manage and supervise a team of professionals to ensure efficient operations. Analyze operational data to identify areas for improvement and optimize processes. Coordinate with various departments to ensure seamless operations and resolve issues. Implement and maintain quality control measures to ensure high standards. Identify and mitigate risks to ensure compliance with regulatory requirements. Job Requirements Proven experience in operations management with a minimum of 5 years of experience. Strong knowledge of operational principles and practices. Excellent leadership, communication, and...

As a Production Planner in a pharmaceutical manufacturing environment, your role involves developing and managing efficient production schedules to meet demand forecasts, optimize resource utilization, ensure compliance with GMP and regulatory standards, and minimize downtime. Your key responsibilities include: - Developing and maintaining detailed production plans based on sales forecasts, inventory levels, and customer orders. - Coordinating with procurement, quality assurance, warehouse, and manufacturing teams to align production plans. - Monitoring production progress and adjusting schedules as necessary to avoid delays and ensure timely product delivery. - Ensuring planning aligns with...

About Zscaler Serving thousands of enterprise customers around the world including 45% of Fortune 500 companies, Zscaler (NASDAQ: ZS) was founded in 2007 with a mission to make the cloud a safe place to do business and a more enjoyable experience for enterprise users. As the operator of the world’s largest security cloud, Zscaler accelerates digital transformation so enterprises can be more agile, efficient, resilient, and secure. The pioneering, AI-powered Zscaler Zero Trust Exchange™ platform, which is found in our SASE and SSE offerings, protects thousands of enterprise customers from cyberattacks and data loss by securely connecting users, devices, and applications in any location. Named...

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...

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

Aster Medcity is looking for Specialist.ENT.Aster Whitefield to join our dynamic team and embark on a rewarding career journey Collaborate with cross-functional teams to achieve strategic outcomes Apply subject expertise to support operations, planning, and decision-making Utilize tools, analytics, or platforms relevant to the job domain Ensure compliance with policies while improving efficiency and outcomes 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.

Kotak Mahindra Bank Limited is looking for Area Sales Manager to join our dynamic team and embark on a rewarding career journey Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new p...

Title: Corporate Quality Projects - LIMS Business Unit: Corporate Quality IT Job Grade Executive / Sr. Executive Location: Vadodara Key Responsibilities At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Position Summ...

1. Position: Head Formulation Development (RD) with strong exposure to regulated markets (US, EU)for US Markets 2. Experience: Minimum 22+ years in formulation development, with at least 8-10 years in a leadership role 3. Education: M.Pharm / Ph.D. in Pharmaceutics 4. Key Responsibilities: Lead formulation development activities for new and existing products (Oral solids) Oversee development from pre-formulation to technology transfer Ensure compliance with regulatory requirements (USFDA, EU, etc.) Collaborate with cross-functional teams QA, QC, Regulatory, Manufacturing Hands-on experience with complex generics / novel drug delivery systems Drive innovation and cost-effective formulation st...

Your key responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strat...

The opportunity Were looking for Senior Manager with expertise in Life Sciences Regulatory Compliance and Stakeholder Management to join the leadership group of our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your key responsibilities Client Responsibilities Participate and lead Regulatory Compliance engagements Help manage the financial aspects of engagements by organizing staffing, tracking fees, and communicating issues to project leaders Drive-in business development initiatives along with client management and account management Build strong internal relationships within...