223 Fda Jobs - Page 2

SUMMARY Sr. Site Reliability Engineer Keep Planet-Scale Systems Reliable, Secure, and Fast (On-site only) At Ajmera Infotech , we build planet-scale platforms for NYSE-listed clients from HIPAA-compliant health systems to FDA-regulated software that simply cannot fail. Our 120+ elite engineers design, deploy, and safeguard mission-critical infrastructure trusted by millions. Why You’ll Love It Dev-first SRE culture automation, CI/CD, zero-toil mindset TDD, monitoring, and observability baked in not bolted on Code-first reliability script, ship, and scale with real ownership Mentorship-driven growth with exposure to regulated industries (HIPAA, FDA, SOC2) End-to-end impact own infra across Dev and Ops Requirements Key Responsibilities Architect and manage scalable, secure Kubernetes clusters (k8s/k3s) in production Develop scripts in Python, PowerShell, and Bash to automate infrastructure operations Optimize performance, availability, and cost across cloud environments Design and enforce CI/CD pipelines using Jenkins, Bamboo, GitHub Actions Implement log monitoring and proactive alerting systems Integrate and tune observability tools like Prometheus and Grafana Support both development and operations pipelines for continuous delivery Manage infrastructure components including Artifactory, Nginx, Apache, IIS Drive compliance-readiness across HIPAA, FDA, ISO, SOC2 Must-Have Skills 3 8 years in SRE or infrastructure engineering roles Kubernetes (k8s/k3s) production experience Scripting: Python, PowerShell, Bash CI/CD tools: Jenkins, Bamboo, GitHub Actions Experience with log monitoring, alerting, and observability stacks Cross-functional pipeline support (Dev + Ops) Tooling: Artifactory, Nginx, Apache, IIS Performance, availability, and cost-efficiency tuning Nice-to-Have Skills Background in regulated environments (HIPAA, FDA, ISO, SOC2) Multi-OS platform experience Integration of Prometheus, Grafana, or similar observability platforms Benefits What We Offer Competitive salary package with performance-based bonuses. Comprehensive health insurance for you and your family. Flexible working hours and generous paid leave . High-end workstations and access to our in-house device lab. Sponsored learning: certifications, workshops, and tech conferences.

Overseeing the networks, servers, and operating systems to ensure seamless functionality, stability, and high performance across all sites, including managing legacy systems and integrating new technologies like IoT and cloud solutions. Leading the implementation of IT projects, including system upgrades, migrations, and new technology rollouts, ensuring they are completed on time, within scope, and within budget. Collaborating with senior management to develop and execute the IT strategy, identifying and recommending technology solutions to improve operational efficiency, production processes, and business growth within the manufacturing environment. Ensuring compliance with relevant industry standards and regulations (e.g., GMP and FDA guidelines in the pharmaceutical industry). Implementing and maintaining robust security measures, including firewalls, antivirus solutions, and intrusion detection systems, to protect sensitive data and systems from cyber threats, ensuring compliance with industry regulations and best practices (e.g., SOX, ISO 27001, ISO 22301). Key Skills and Attributes: Proficient in IT infrastructure, networks, operating systems (e.g., Microsoft and Linux), databases, and cloud solutions (e.g., AWS, Azure, Google Cloud). Knowledge of cybersecurity best practices, risk management, threat detection, and compliance requirements. Ability to manage, analyze, and leverage data effectively for process optimization, forecasting, and improved decision-making. Familiarity with technologies shaping manufacturing, such as Industry 4.0, Industrial IoT, AI, Machine Learning, Robotics, Automation, Digital Twins, Additive Manufacturing, and AR/VR. Practical experience in integrating Information Technology (IT) and Operational Technology (OT) systems within manufacturing environments (e.g., ERP, MES, SCADA, ICS). Network Infrastructure, ERP Systems, Operational Technology (OT), Cybersecurity, Industrial Automation & IoT, Data Analytics, Cloud Computing, Server Management. Active Directory configuration DNS/DHCP Server

Objectives Of The Position Responsible for Regulatory strategy of South Asia, ASEAN, ANZ (close collaboration with strategic Regulatory management team) Responsible for all compliance activities in South Asia, ASEAN, ANZ Responsible for all registration activities in South Asia, ASEAN, ANZ Consolidate and communicate prioritization of product registrations and regulatory submissions Provide customer support beyond BASF for end users, supporting customers in preparation of drug product submissions and responses to deficiency questions from Health authorities Consolidate and communicate development in the South Asia, ASEAN, ANZ regulatory environment Regulatory representative for BASF Pharma in South Asia, ASEAN, ANZ Main Areas If Responsibility And Key Activities Regulatory Prepare and compile the checklist and documents for Active Ingredients, New application and renewal applications; Coordinate with global and regional regulatory on strategizing the approach for new and renewal application submission, authority deficiency questions and post approval variations Coordinate with global and regional regulatory for regulatory/quality documents support for customer requests Understand the gaps on the analytical questions from customers and provide interim or immediate support Establish an overview on upcoming and updated regulatory guidelines and identify the top focus topics for South Asia, ASEAN, ANZ Actively participate in the Regulatory process including monthly/ quarterly country calls, regional reporting and Global RA meetings Customer support Provide complete and timely support to internal and external customers on regulatory matters Industry representation Represent BASF Pharma at South Asia Pharma/Excipients associations (e-g IPEC India) Others Engage with South Asia sales head and sales colleagues to understand the business needs and potential Job Requirements Minimum Bachelor Degree in Science/ Pharmacy Minimum 5 years of regulatory and quality experience in pharmaceutical industry Understand India regulatory and US FDA guidelines Prior experiences in Regulatory Affairs/ Quality Control laboratory Team player with strong communication skills Can speak English and Hindi (preferred)

As a global leader in assurance, tax, transaction, and advisory services, we at EY are dedicated to hiring and nurturing the most passionate individuals in their respective fields, all in an effort to contribute towards creating a better working world. Our culture is rooted in the belief that every individual deserves the training, opportunities, and creative freedom essential for growth. At EY, we are not solely interested in your current capabilities, but in the potential of who you can become. We firmly believe that your career is yours to shape, with limitless possibilities awaiting you. Throughout your journey with us, we are committed to providing you with inspiring and fulfilling experiences that will aid you in evolving into the best version of your professional self. The position available is for a Senior Consultant in the National Forensics team, focusing on Forensics Discovery in Hyderabad. Your primary responsibilities will include showcasing technical excellence in the field, particularly in relation to FDA. To qualify for this role, you must possess the necessary qualifications and experience in FDA. We are seeking individuals who can collaborate effectively across various client departments, adhering to both commercial and legal standards. You should have a pragmatic approach to problem-solving, with the ability to offer insightful solutions to complex issues. We value individuals who are agile, inquisitive, mindful, and can maintain a positive attitude while also being adaptable and innovative in their problem-solving strategies. EY is proud to be associated with over 200,000 clients globally, with a workforce of 300,000 people worldwide and 33,000 employees in India alone. We have established ourselves as a leading brand and an employer of choice in our industry, showcasing exceptional growth and a commitment to excellence. Our team collaborates with influential entrepreneurs, game-changers, disruptors, and visionaries, providing ample opportunities for growth and development. We are dedicated to investing significant resources in skills development and learning initiatives for our employees. At EY, you will embark on a personalized Career Journey and have access to our comprehensive career frameworks to gain insights into your roles, skills, and potential opportunities. EY is deeply committed to promoting diversity and inclusivity in the workplace, ensuring that our employees strike a balance between delivering excellent client service and focusing on personal growth and well-being. If you believe you possess the qualifications and attributes outlined above, we encourage you to reach out to us promptly. Join us in our mission to build a better working world by applying now.,

Are you passionate about driving clinical quality and compliance Do you have a proven track record in clinical operations and a knack for innovation and process improvement If you're ready to take on a leadership role that makes a real impact, we invite you to explore this exciting opportunity, apply today for a life-changing career! As the Head of Clinical Operational Excellence, you will play a pivotal role in ensuring clinical quality, compliance, and operational excellence. Your key responsibilities will include performing risk assessments and trend analyses to proactively address clinical quality risks, ensuring audit and inspection readiness including CAPA documentation and stakeholder communication, representing the CDC in regional and global clinical quality forums, ensuring compliance with local regulatory requirements, coordinating Quality Management Reviews (QMR), developing and executing yearly training plans aligned with operational strategies, driving innovative solutions for operational efficiency such as digital visit tracking and RBQM, identifying and implementing process improvements, conducting stakeholder satisfaction checks, measuring the effectiveness of new processes, and communicating with external Regulatory Authorities FDA, EMA, CDSCO, PMDO. To be successful in this role, you should have 15+ years of experience in clinical operations with a minimum of 3 years in clinical quality, 5 years of direct team handling experience with 360* performance management, completed qualifications in Medical, Pharmacy, Life Sciences, or another related field, a track record of driving innovation and process improvements in clinical operations, experience with digital tools and systems for operational excellence, excellent communication, and stakeholder management skills. The Clinical Development Centre (CDC) India is at the forefront of ensuring clinical quality and operational excellence. Based in a fast-paced and dynamic environment, the department proactively addresses clinical quality risks through risk assessments and trend analyses, ensures audit and inspection readiness, maintains compliance with local regulatory requirements, drives innovative solutions such as digital visit tracking and RBQM, represents CDC in global forums, and fosters collaboration with external regulatory authorities. With a culture of continuous improvement and a commitment to operational efficiency, the team thrives on delivering impactful results that make a difference. If you are interested in submitting your application, please upload your CV and motivational letter online. Internal candidates are kindly requested to inform their line Managers before applying. The deadline for applications is 01st Aug. 2025. Novo Nordisk is committed to an inclusive recruitment process and equality of opportunity for all job applicants. The company recognizes the importance of creating an inclusive culture that celebrates the diversity of employees, patients served, and communities operated in. Together, Novo Nordisk strives to be life changing.,

Function:PMSRole:Post Market SurveillanceDesired Skills:PMS, complaint handlingCreate PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis Risk management Risk assessment. Required Candidate profile Propose strategies and solutions to data issues or challenges that occur during the PSUR writing and conclusion process.

Hiring for the role of Documentation Job Title: Documentation Level Executive / Sr. Executive Experience: 3-5 Years Location: Ankleshwar Job Summary: The Documentation Engineer will be a key member of the execution team, responsible for managing and maintaining documentation related to installation, commissioning, and qualification of process and utility equipment. This role is ideal for mid-level professionals (3-5 years of experience) looking to advance their expertise in installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for equipment used in pharmaceutical, chemical, and food processing industries. Key Responsibilities: Prepare and maintain IQ, OQ, PQ documentation for micronizing mills, containment isolators, bulk handling systems, and fluid bed dryers. Ensure documentation aligns with industry GMP, FDA, and other regulatory standards for equipment validation. Support audits by maintaining structured records for qualification processes on day to day basis. Assist in the installation, commissioning, and qualification of high-containment and powder- handling equipment. Coordinate with internal teams and vendors for proper setup and troubleshooting of process equipment, Provide technical support for operation and maintenance of containment solutions. Work with senior engineers to troubleshoot automation systems, PLCs, and electrical components. Analyse equipment efficiency and contribute to continuous improvement initiatives. Maintain electrical consumption reports to optimize operational performance. Required Skills & Qualifications: Bachelor's degree in Engineering (Mechanical / Electrical / Chemical / Pharmaceutical) or relevant field. Hands-on experience with technical documentation processes and validation protocols. Strong understanding of process equipment installation and validation. Experience in project execution and vendor coordination. Familiarity with automation systems, PLCs, and process equipment troubleshooting. Proficiency in MS Office Suite, AutoCAD, and documentation software. If anyone is interested in this role kindly share resume to zalak.rohit@cielhr.com

Responsible for manufacturing of all types of Tablet / Capsule / Powder (FDA Approval Must) Responsible for timely delivery with Quality and Quantity Responsible for motivation and handling of manufacturing workforce New Product Development Conduct Technical Non Technical Trainings Manufacturing of Tablet Capsules (Ayurvedic Allopathy) Predict, handle and rectify manufacturing defects Man management skills Knowledge of GMP guidelines Efficient in Documentation 2 - 3 Yrs at junior / executive position of similar profile

You will be working as a Manufacturing Operator in the Pharma Solution business unit within the Operations department located in Lexington. Your primary responsibilities will include performing various production activities such as component preparation, filling, capping, autoclaving, compounding, and lyophilization production. You will report directly to the Manufacturing Supervisor. In this role, you will be required to comply with all relevant policies and procedures set forth by PPS and various regulatory agencies. Some of your key responsibilities will involve performing line clearances, cleaning and sterilization of equipment, operation of aseptic filling equipment, executing validation protocols, maintaining production records, and ensuring compliance with Good Manufacturing Practices and Standard Operating Procedures. To be successful in this position, you should have a high school education or equivalent qualification, along with at least 2 years of experience working in an industrial or manufacturing environment. Prior experience in pharmaceutical manufacturing or aseptic manufacturing is preferred. You should also possess mechanical aptitude, the ability to follow regulatory requirements, and be a team player committed to quality and collaboration. Your role will require you to operate and maintain production equipment, weigh and measure raw materials, maintain cleanliness in the work area, and collaborate effectively with other functional groups such as quality, validation, and supply chain. Additionally, you will be responsible for reviewing production documentation for quality and compliance, participating in troubleshooting activities, and providing on-the-job training for new operators. The Piramal Group, under which Piramal Pharma Solutions operates, is dedicated to inclusive growth and ethical practices. As part of the team at PPS, a Contract Development and Manufacturing Organization, you will contribute to providing end-to-end development and manufacturing solutions across the drug life cycle. The organization offers a wide range of services globally, including drug discovery, process development, clinical trial supplies, commercial supply of APIs, and specialized services for biologics. As a Manufacturing Operator, you will play a crucial role in contributing to the success of the production operations at Piramal Pharma Solutions. Your dedication to quality, regulatory compliance, and teamwork will be essential in achieving production goals and maintaining a high standard of manufacturing excellence.,

As an Analytical Chemist at Linde, you will utilize your knowledge of Quality control and GMP under FDA guidelines to ensure targets are met and plant parameters are optimized for maximum output and efficiency. Your role will involve ensuring compliance with local regulations and obtaining necessary approvals/licenses, particularly from the FDA. You will also play a key role in selecting suitable suppliers, agreeing on technical scope/solutions, conducting stage gate inspections for quality assurance, and assessing technical competency to assign tasks accordingly while ensuring safety and quality standards are maintained. Additionally, you will be responsible for making purchases for materials, assets, and services, as well as coordinating maintenance and troubleshooting activities. Your contribution will be vital in implementing directives, alerts, and improvement initiatives, as well as developing and sharing Root Cause Analysis reports. To excel in this role, you should hold a degree in B Sc Chemistry/BE/Bachelor of Pharmacy or an equivalent qualification, coupled with a minimum of 5 years of experience in the relevant field. Your ability to ensure compliance with local regulations and obtain necessary approvals/licenses, especially from the FDA, will be crucial to your success in this position. Linde is a globally renowned industrial gases and engineering company with operations in over 100 countries. We are committed to making the world more productive by providing high-quality solutions, technologies, and services that empower our customers, drive success, and contribute to the sustainability and protection of our planet. The joint venture between Linde India Limited and Praxair India Private Limited, LSAS Services Private Limited, aims to provide Operations and Management services to both entities while upholding a legacy of sustainable development and technological innovation in the industrial gases industry. As part of the Linde family, you will have limitless opportunities to realize your potential, make a positive impact, and contribute to a better world. Join us at Linde and embrace the limitless possibilities that lie ahead! If you are inspired by our vision and eager to be part of our dynamic team, we invite you to submit your complete application, including a motivation letter, CV, and certificates, through our online job market. Linde South Asia Services Pvt. Ltd. upholds a strong commitment to responsible business practices, technological innovation, and sustainable development across all its operations worldwide. We value diversity and inclusivity, and the language used here is intended for simplicity and clarity for all individuals.,

Role & responsibilities Liaison with Food & Drugs Control Administration, Gandhinagar/circle offices/CDSCO for various applications including but not limited to Product Permissions for manufacturing COPPs Various certificates for tender (FSC, Performance certificate, Non-conviction certificate) Inspections for WHO GMP/Schedule M GMP certification Technical persons approval Technical person application verification. Liaison with CDSCO, West Zone, Form 29 Export licenses Loan license Manufacturing licence renewal for all plants Wholesale licences Submission of commercial batches to CDL Kasauli for testing Submission of quarterly returns to NCB/CBN Handling NSQs Experience in submissions through Sugam, NSWS and ONDLS portals Preferred candidate profile Must have experience in the pharmaceutical industry

Position: Production Head Experience: 10 To 20 Yrs Location: Bangalore Department: Manufacturing Industry: Medical Devices / Healthcare Technology Role Summary We are looking for an experienced and strategic Production Head to lead our manufacturing operations in the medical device domain. The ideal candidate will have deep knowledge of regulated production environments, strong people management skills, and a passion for driving quality, safety, and efficiency. This role is critical to ensuring that our products meet global standards and are delivered on time and within budget. Key Responsibilities Lead and oversee all daily manufacturing activities, ensuring production targets, timelines, and quality standards are met. Develop and implement effective production strategies aligned with company goals. Ensure full compliance with regulatory and quality standards, including ISO 13485, FDA21 CFR Part 820, and EU MDR. Manage cleanroom operations and ensure adherence to safety and hygiene protocols. Plan and optimize resource allocation including manpower, materials, and machines. Implement and promote Lean Manufacturing, 5S, Six Sigma, and other process improvement techniques. Coordinate with cross-functional teams such as Quality, R&D, Regulatory Affairs, SCM, and Maintenance. Oversee preventive and corrective maintenance of production equipment and ensure minimal downtime. Ensure documentation practices meet Good Manufacturing Practices (GMP), including DMR, DHR, CAPA, NCR, etc. Train, mentor, and lead the production team to drive productivity and accountability. Participate in internal, external, and regulatory audits. Qualifications Bachelors/Masters degree in Mechanical / Industrial / Biomedical Engineering or related field. Certifications in Lean, Six Sigma (Green/Black Belt), or ISO 13485 are an advantage. Experience 12-20 years of experience in manufacturing, with at least 5 years in the medical device or pharma industry. Prior leadership role in managing large-scale, regulated production lines. Key Competencies In-depth knowledge of regulatory standards (ISO 13485, GMP, FDA, EU MDR). Excellent team leadership, communication, and conflict-resolution skills. Proven track record in implementing continuous improvement and cost-saving initiatives. Hands-on experience with ERP/MES systems. Strong analytical and decision-making abilities. Why Join Us? Opportunity to lead in a fast-growing, innovation-driven organization Work on cutting-edge medical technologies that impact lives A culture that values quality, teamwork, and continuous learning

Job Summary We are looking for a persuasive and knowledgeable Pharmaceutical Telesales Representative to promote and sell our clinically proven testosterone replacement therapy (TRT) products. In this role, you will engage healthcare professionalsincluding primary care physicians, endocrinologists, and urologistsvia phone and digital channels to educate them on the benefits, safety, and appropriate use of our testosterone treatments. The ideal candidate has experience in pharmaceutical or medical sales, with a passion for men’s health and wellness. Key Responsibilities Make high-volume outbound calls to targeted healthcare providers to promote testosterone therapy solutions. Deliver compelling, compliant product messaging that highlights clinical benefits, patient outcomes, and usage protocols. Educate providers on patient eligibility, treatment administration, and monitoring requirements. Build and maintain long-term relationships with prescribers to encourage product adoption and repeat business. Handle objections professionally and effectively communicate evidence-based information. Log all interactions, outcomes, and follow-ups in the CRM system (e.g., Salesforce). Work closely with marketing, medical affairs, and customer service to support provider needs and follow through on inquiries. Stay current on testosterone treatment trends, competitive products, and industry regulations (e.g., DEA, FDA). Achieve and exceed monthly sales quotas and performance metrics. Qualifications Bachelor’s degree in Life Sciences, Healthcare, Business, or related field preferred. 1–3 years of telesales or pharmaceutical sales experience (experience in men’s health, urology, or hormone therapy is a plus). Excellent phone presence, persuasive communication, and active listening skills. Strong understanding of testosterone deficiency (hypogonadism), treatment protocols, and patient education points (training provided). Proficient with CRM platforms and Microsoft Office Suite. Highly organized, self-motivated, and results-oriented. Familiarity with HIPAA, FDA, and telehealth compliance requirements is desirable. What We Offer Competitive base salary with uncapped commission structure Product and compliance training specific to testosterone replacement therapy Opportunities for career advancement in a fast-growing segment of men’s health Health benefits, paid time off, and other perks (as applicable) A mission-driven environment focused on improving patient quality of life

Job Responsibilities Operations Build successful relationships with Life Sciences (LS) client stakeholders to promote confidence in quality and compliance, as well as forward planning. Provide management and leadership direction for the development and implementation of quality and compliance programs. Collaborate with other Life Sciences accounts to proactively accumulate, share and reapply all learnings, successes as well as best practices. Collaborate with Global Life Sciences Quality Vertical for development, revision and implementation of QMS and quality documents. Responsible for ensuring Lide Sciences facilities teams adhere to the required training and ensuring in compliance to clients QMS and quality training requirements. Responsible for ensuring that the work conducted by the Facilities team, and its subcontractors is in full compliance with contractual requirements, clients SOPs, GxP, FDA and other regulations. Able to perform/support internal JLL compliance audits and prepare SOPs, and training materials for use by the Life Sciences facilities team in the performance of their work. Guide Life Sciences facilities team in closing recommendations from clients audit. Expected to interface with the clients quality personnel to ensure that all of the clients SOPs are followed, work performed by the LS facilities team is properly documented for traceability in the framework of GDP. Sustain quality assurance support and develop a Quality Engineering Maintenance program for a controlled-environment manufacturing and laboratory facility as it relates to the facilities maintenance of this plant. Conduct investigations and drive accountability for all quality events. Lead programs to create value for client to ensure program deliveries meet or exceed expectations. Facilitate quality-relevance investigation via structured Root Cause Analysis. As part of career development, lead Life Sciences accounts as an IFM leader.Reporting Manage and report on critical & key performance measurements. Develop and submit periodic site status reports related to the Quality Program. People Management Effectively lead and guide a Life Sciences Quality team by clearly communicating expectations, accountabilities and providing performance feedback for continuous improvement. Ensure Life Sciences Operations team members complete relevant quality and compliance training. Coach new Life Sciences team members on quality and compliance for their adaptation into specific Life Sciences accounts. Mentor, develop and train peer and direct report team members. Provides direction/information to vendors, facilities staff and service providers as required to ensure that quality assurance expectations are communicated and followed.Others Any other quality-relevant duties and tasks assigned. Knowledge, Skills & Abilities. MINIMUM REQUIRED / PREFERRED - Education/training Bachelor degree preferred Degree in science, technical or relevant discipline Sound fundamental knowledge in process utilities. 6+ Years of relevant experience preferred with minimum 4+ years in Quality and Compliance discipline in GxP manufacturing or laboratory environment. Six-Sigma and Root Cause Analysis training is essential. Skills and knowledge Background in technical documentation Work independently and within a team. Strong mindset of compliance and client-focus. Communicate effectively with technical, quality assurance and other personnel. Proficient in Word, Excel and other Microsoft Office Suite programs Ability to investigate, recognize and diagnose trends and patterns. Solid understanding of cGMPs as they relate to the performance of maintenance and repairs to facilities, utilities and equipment utilized for the manufacturing plants and laboratories for drug products. Experience working at an FDA regulated manufacturing facility in a quality assurance or quality control capacity. Support investigations and corrective action plans for appropriate discrepancies. Investigation of compliance issues as required, collaborating with relevant Compliance Partner(s) Understanding of FDA regulations including 210 CFR part 210 and 211. Strong commitment to quality assurance, and a willingness to help develop a quality first culture on the site. Knowledge of Quality Engineering techniques, CMMS systems, and Quality Management Systems English communication is essential Other abilities Good oral and written communication skills including the ability to communicate to all levels of management and willing to interface with a diverse customer base including technical and non-technical personnel.Physical work requirements and work conditions Familiar with process utilities and GxP environment.

You'll make a difference by The work involves System Testing of Products based out of Batch Products of PCS 7. Responsible for Designing, writing, reviewing, and executing test cases, and Test case automation for Products based out of PCS 7. Responsible for writing bug reports and verifying them after fixes. In Addition, responsible for carrying out Performance Tests. Performs Test Automation of existing Test cases Involves in interacting with Business Partners for technical clarifications. You'd describe yourself as A graduate with 4-5 years of total experience in DCS with experience in Batch process like Pharma, F&B, Oil & Gas, etc. (experience in PCS 7 SIMATIC Batch is an added advantage). Commissioning experience of process plants (Batch applications) Hands-on Experience with SIMATIC Batch, Route Control In depth understanding on FDA, GMP and CFR Worked on Redundant PLCs configurations. Worked on Failsafe configurations. Worked on SCADA HMI (in-depth knowledge) Hands on working Exp. on continuous and sequential control logics. Hands on working Exp. on field devices. Knowledge of communication interfaces like MPI, Profibus, Profinet, Ethernet TCP/IP Knowledge on Product Testing.

Provide outstanding editorial services for all designated projects, including editing, fact-checking, and proofreading on assigned brand(s) Follow established procedures/guidelines to ensure consistent work quality Develop and maintain style guides for any assigned brands Understand the product and the clients objectives, including product information, visual aids, pivotal trials, journal articles, and related promotional materials Prioritize work appropriately, while meeting all deadlines Collaborate effectively and communicate proactively to enhance dynamics within and among teams Adhere to AMA and brand style requirements Attend kickoff, hot-sheet, and status meetings related to assigned projects Proactively manage workload, and escalate concerns relating to quality and timing as needed Assist in training and onboarding of new editors on the team Background/experience and skills Bachelor s or postgraduate degree in a related field, with 3-5 years of industry experience Ability to work independently as well as collaboratively Meticulous attention to detail Strong working knowledge of current AMA style (11th edition) preferred Excellent interpersonal, written, and oral communication skills Proficiency in English grammar and usage Familiarity with digital media (navigating web/device interfaces) Experience with digital routing systems Familiarity with FDA regulations regarding pharmaceutical advertising preferred Proficiency in MS Office, including Word, Excel, and PowerPoint

Role & responsibilities Architect and implement a lean, auditready ISO13485:2016 Quality Management System and drive certification. Own all designcontrol documentation (SRS, DHF, Risk Management File, DMR, Technical File, etc.) in collaboration with engineering teams. Define and execute regulatory strategies: first CDSCO (ClassII/III), then FDA 510(k), and EU MDR CE Mark. Prepare, review, and submit regulatory dossiers; interact with authorities and notified bodies. Plan and conduct internal audits, manage CAPA investigations, and lead continuousimprovement initiatives. Qualify and monitor suppliers/CMOs; establish incoming and inprocess quality controls and batchrelease records. Train crossfunctional teams on standards, good documentation practices, and change control. Set up postmarket surveillance, complaint handling, and vigilance procedures ahead of launch. Preferred candidate profile Bachelors degree in engineering, Life Sciences, or related field; ISO13485 internalauditor certification preferred. 5 –10years’ QARA experience with ClassII (or higher) medical devices, ideally in a startup/smallteam environment. Demonstrated handson implementation of ISO13485 and compilation of CDSCO dossiers or FDA/CE submissions. Working knowledge of ISO14971, IEC62304, IEC60601, and Indian MDR2017; familiarity with EU MDR and 510(k) processes. Strong documentation skills, analytical mindset, and ability to translate regulatory language into actionable tasks for engineers. Selfstarter who thrives with minimal supervision and juggles multiple priorities in a fastmoving startup.

Job Title: Labelling Specialist - Medical Devices Location: Sanand, Ahmedabad Department: Quality Assurance Employment Type: Full-Time (On-Site) Reports To: Quality Manager Job Summary: We are seeking a detail-oriented and knowledgeable Labelling Specialist to manage the creation, review, and maintenance of labelling content for our medical devices. The ideal candidate will have a strong understanding of medical device regulations and be well-versed in labelling standards, particularly ISO 15223. This role is critical to ensuring our product labels are compliant, accurate, and aligned with global regulatory requirements. Key Responsibilities: Develop and maintain medical device labels artwork in compliance with applicable regulatory requirements. Ensure labelling content aligns with ISO 15223 (Symbols to be used with medical device labels, labelling and information to be supplied). Collaborate with cross-functional teams including Regulatory Affairs, Quality Assurance, R&D, and Marketing to gather and validate labelling information. Review labelling changes and provide regulatory input during product development and product updates. Ensure labels comply with regional regulations such as MDR (EU), FDA (US), and other relevant markets. Maintain labelling documentation and change control records in accordance with internal procedures. Monitor updates to labelling standards and regulations and assess their impact existing labelling. Qualifications and Requirements: Bachelor's degree in a scientific, engineering, or healthcare-related discipline. Minimum 2 years of experience in a regulated medical device environment, preferably in labelling or regulatory affairs. Strong knowledge of ISO 15223 and other applicable standards (e.g., ISO 20417, IEC 60601, UDI regulations). Familiarity with regulatory requirements for labelling under EU MDR, US FDA, and other global regulations. Experience with labelling software tools (CorelDraw, Adobe Illustrator or similar tools) and document control systems is a plus. Excellent written and verbal communication skills. High attention to detail and ability to work independently and in teams.

Job Summary A detail-oriented and results-driven Adobe Campaign Technical Consultant with experience in the banking or financial services domain The ideal candidate will have 4+ years of experience designing, executing, and optimizing data-driven marketing campaigns using Adobe Campaign The role requires strong proficiency in SQL and experience with ETL tools such as SSIS to manage end-to-end campaign workflows, including data extraction, transformation, and loading from complex data environments The candidate will work closely with marketing, data, and compliance teams to deliver targeted communications, enhance customer engagement, and ensure regulatory adherence Key Responsibilities 1. Design and implement personalized 1:1 customer communication journeys using Adobe Campaign. 2. Build and optimize workflows and campaign automation to support acquisition, retention, and cross-sell initiatives for banking products. 3. Extend and customize Adobe Campaign database schema to align with customer lifecycle and compliance requirements. 4. Work with SQL to extract, transform, and segment customer data from banking data warehouses and external sources (via FDA or ETL processes). 5. Design and maintain ETL processes using tools like SSIS to enable seamless campaign data integration. 6. Ensure compliance with banking regulations (e.g., data privacy, opt-out preferences) in all campaigns. 7. Coordinate the execution, testing, monitoring, and tracking of multichannel campaigns (Email, SMS, Push). 8. Manage offer library and dynamic content blocks for various banking services (credit cards, loans, savings accounts). 9. Collaborate with marketing teams to deliver campaigns aligned with business goals and regulatory policies. 10. Resolve high-priority production issues and ensure minimal impact on critical campaigns. 11. Monitor delivery rates, bounce rates, and engagement metrics, and recommend data-driven improvements. Required Skills and Experience 1. 4+ years of experience in Adobe Campaign development and end-to-end campaign execution. (Mandatory) 2. Strong proficiency in SQL for data extraction, segmentation, and transformation. 3. Experience with ETL processes and tools such as SSIS for handling campaign data flows. (Mandatory) 4. Hands-on experience with campaign workflow orchestration and Adobe Campaign Classic or Standard. 5. Hands-on experience with HTML/CSS for email template customization. 6. Experience working with banking or financial institutions is preferred. 7. Good understanding of data privacy laws (e.g., GDPR, local banking compliance standards). 8. Experience with FDA (Federated Data Access) integration for data extraction. 9. Strong communication skills and ability to work in cross-functional teams. Nice to Have 1. Knowledge of other marketing automation platforms. 2. Exposure to reporting tools and dashboards to measure campaign performance.

You will be responsible for reviewing and conducting chemical testing of raw materials, finished products, cosmetics, Ayurveda, Sidha & Unani products. You will need to accurately enter the test results into the LIMS software. Additionally, you will be required to handle instruments like HPLC, GC, FTIR, Dissolution, etc. Technical documentation in compliance with FDA, CDSCO & Ayush standards for audits will also be part of your responsibilities. The position is based in Gurugram and requires a minimum qualification of B.Pharma, M.Pharma, MSc. Chemistry or a related field. The ideal candidate should have 2 to 15 years of relevant experience.,

Required Qualifications: Bachelors or master’s degree in mechanical, electrical, or Systems Engineering , or a related technical field. 3+ years of experience in V&V for medical devices , ideally with complex systems involving fluidics, embedded systems, or renal therapy technologies . Hands-on experience designing and executing verification tests for software-controlled electromechanical systems. Strong knowledge of systems engineering principles , including the V-model , requirement validation, and test traceability. Proficient in using lab instrumentation (e.g., flow meters, pressure sensors, data acquisition systems).

Greetings, Hope you are doing fine! NOTE: We apologize if any inconvenience is caused or if this job opening is irrelevant / not of interest to you and request you to ignore this mail. We have an job opening with a leading HealthTech company Position: Head of Compliance Location: Bangalore JD: Need a candidate having experience in Compliance, HIPAA, SaMD, and FDA. If interested in the profile, kindly send us your updated CV to debraj.bhattacharya@connexio.asia and ankit.kumar@connexio.asia Also, it would be great if you could help me with the following details Current Fix CTC: Expected CTC: Notice Period: Current Location: Thanks, Mona Shah Recruitment Team Email: mona.shah@connexio.asia

Role & responsibilities Shall be take care of process Equipments ( preventive Maintenance , Breakdown , QMS ) Preferred candidate profile Candiate should have very deep knowledge about preventive maintenance and breakdown activities pertaining process equipments. Also shold velwersed with QMS GMP activities.

Review SOP Support quality system Familiar with process/cleaning validation Assist internal & external audits Assist specification settings, OOS investigation, change controls, regulatory submission/update, annual product reviews, other investigation Required Candidate profile Must have min. 2 yrs experience & must be familiar with cGMP requirements. Candidate should have good knowledge of computer & ability to effectively interact with individuals at all levels.

Company: Yash Technology Location: Bangalore Experience: 6+ years Mode of work: Work from Office Type of employee: Full Time Employee Shift Timings: 12PM - 9PM Interested and relevant candidates share your profile to padma.ashwitha@gmail.com Essential Duties and Responsibilities: • Possesses solid understanding of overall vision and business needs and utilize specialized expertise to collaborate with Quality and Operations to define detailed User Stories for D&T enablement of business needs. This includes interpreting any issues and recommending solutions or best practices. • Utilizes knowledge of best practices to help define strategic direction, help determine business needs and design & deliver technical solutions for QA, in partner with Application and Infrastructure. • Essential core member of agile sprint team(s) to configure and develop optimal technical solutions / features. • Provide technical delivery of functionality to meet defined business requirements as described in User Stories. • Provide system support and maintenance in alignment with standards and process set within the ERP Services Delivery model, West policies and procedures as well as Regulatory requirements including but not limited to Sarbanes-Oxley and FDA GMP. • Create and maintain system lifecycle documents in accordance with West policies and procedures, including creation and maintenance of SOPs, SOIs and Job Aids. • Work within and participates in the Change Control process. • Other duties as assigned. Education and Experience: • Bachelors degree or equivalent experience in Computer Science or Information Systems • 7+ years of related work experience, i.e. 3 or more full implementations of SAP QM solutions • Preferred but not required: Agile & Scrum Certification, ITIL . Knowledge, Skills and Abilities: • Solid SAP skills system functionality and technical understanding of QM and related areas (PP, MM, PM) • Must be up to date on latest ERP release. • Strong HANA knowledge preferred • Ability to work in a virtual environment in a global organization and to effectively prioritize and execute tasks in a high-pressure environment. • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description • Support and contribute in Lean Sigma programs and activities towards delivery of the set target • Able to comply with the companys safety and quality policy at all times. Physical and Travel Requirements: • 15% travel, including global travel • Occasional on-call work required • Prefer 12pm 9pm India time. Willingness to work outside of these hours as needed. Regards, P. Ashwitha