331 Usfda Jobs - Page 9

: Established in 1991, Matrix (www.matrixcomsec.com) is a leader in Security and Telecom solutions for modern businesses and enterprises. Matrix has launched cutting-edge products like Video Surveillance Systems - Video Management Software, Network Video Recorder, and IP Camera, Access Control and Time-Attendance Systems as well as Telecom Solutions such as Unified Communications, IP-PBX, Universal Gateways, VoIP and GSM Gateways, and Communication Endpoints. These solutions are feature-rich, reliable, and conform to international standards. Having global footprints in Asia, Europe, North America, South America, and Africa through an extensive network of more than 2,500 channel partners, Matrix ensures that the products serve the needs of its customers faster and longer. We aspire to be the world leader in innovative telecom and security solutions by offering cutting-edge, high-performance telecom and security solutions to business customers. Roles and Responsibilities : Maintain client relations to build excellent reputation for service and produce repeat business. Interact regularly with top ten accounts related to weekly selling, deliveries and stock availability. Maintaining contact with existing clients to ensure that they are satisfied with their services Building relationships with existing clients to ensure repeat business and new business opportunities Managing existing customer accounts by ensuring that existing customers remain satisfied with company products and services. Developing and implementing effective account plans to retain existing customers. Identifying customer needs and communicating how company products and services fulfill those needs. Suggesting innovative ways to increase sales and enhance clients' experience. KRA's: Sales from regular SI's Number of SI's build How to get constant business from SI's Skills Required: Ability to increase customer engagement. Knowledge of customer relations management software and MS Office. Outstanding communication and negotiation skills. Analytical and time management skills.

About the Role: Grade Level (for internal use): 09 The Role This position is an individual contributor within the Internal Audit team responsible for performing audit engagements including U.S. Sarbanes-Oxley (SOX) Compliance testing. This position will contribute significantly to SOX testing efforts and evaluating compliance with corporate policies, assessing risks over the IT operating environment and identifying operational efficiencies. The Impact The IT SOX Specialist will work closely with your direct manager and the process owners to gain an understanding of key processes, key controls, identify control gaps by strengthening and monitoring the internal control environment to provide assurance in the accuracy of reported financial information for a leading data provider worldwide. Whats in it for you You will interact with key process owners and colleagues across the Company. You will also be responsible for completing the audits and projects as outlined in the Internal Audit Plan and play a critical role in assessing the effectiveness of the control environment and providing value added recommendations across the organization. You will gain a robust understanding of the operations of all divisions and functions within the company. Ability to collaborate with a global team of seasoned financial services/audit professionals and access to the latest technological and data analytic tools Competitive compensation package with excellent benefits, including generous paid time off, tuition reimbursement, parental leave and more Advancement opportunities in a global company with presence in 30+ geographies The Team / The Business We have teams made up of people that work effectively together, while working with the larger group of auditors. Opportunities are presented every day to work with people from a wide variety of backgrounds and to develop a close team dynamic with coworkers from around the globe. The Internal Audit function is a global team with presence in all regions (Americas, EMEA and Asia Pacific). The function is independent and reports functioning to the Audit Committee. Responsibilities Lead and perform IT audits focused on compliance with Sarbanes-Oxley (SOX) regulations, ensuring that IT general controls and IT automated controls are effectively designed and operating. Develop, document, and execute test plans for IT controls, ensuring that they meet SOX requirements and are functioning as intended. Utilize GenAI, data analytics and automation tools to enhance audit processes, identify trends, and uncover anomalies in IT systems. Evaluate the SDLC processes to ensure proper controls are in place during system development, implementation, and maintenance. Stay updated on emerging IT risks and controls, including cloud computing, cybersecurity threats, and data privacy regulations. Participate in projects across the internal audit department, including risk-based audits and project assurance initiatives, to enhance overall audit effectiveness and efficiency. What Were Looking For You will be an effective communicator, in both verbal and written form, and an analytical thinker who employs logic and persuasion to influence with diplomacy and tact. You will be a proactive, innovative, collegial team player who can be accountable and absorb/integrate ideas from diverse views, create partnerships and collaborate with others. You will be nimble in learning and support the implementation of agile techniques. You will be responsible for balancing stakeholders and building/fostering relationships with stakeholders. You have a strong interest to learn, embrace agile auditing techniques, adoption of data analytics and emerging tools to strengthen quality of audit execution and SOX controls testing. Basic Qualifications: The ideal candidate must be an experienced audit professional with skills in IT SOX, internal audit, or related roles in control function organizations. Experience/exposure with different data analytics tools (such as Tableau, Alteryx, Power BI, etc.). Agility to support different Internal Audit capabilities such as business/data/IT auditing and SOX compliance. Minimum 3-5 years of relevant experience of IT controls-based testing through planning audits, conducting audit procedures, and preparing audit reports. Understanding and operational application of Sarbanes-Oxley Section 404 Public Accounting experience. Knowledge of or experience with providing audit support during integrated financial and operational audits. Knowledge or experience with information security controls. Experience with electronic work papers and standard productivity tools Bachelor's or Master's degree in Computer Science, Engineering, Information Technology, or a related field. Willing to travel (domestic and international), limited to 10 - 15% Professional certifications preferred but not required (CISA, CIA, CPA, etc.). #L1-RS2 Whats In It For You Our Purpose: Progress is not a self-starter. It requires a catalyst to be set in motion. Information, imagination, people, technologythe right combination can unlock possibility and change the world.Our world is in transition and getting more complex by the day. We push past expected observations and seek out new levels of understanding so that we can help companies, governments and individuals make an impact on tomorrow. At S&P Global we transform data into Essential Intelligence, pinpointing risks and opening possibilities. We Accelerate Progress. Our People: Our Values: Integrity, Discovery, Partnership At S&P Global, we focus on Powering Global Markets. Throughout our history, the world's leading organizations have relied on us for the Essential Intelligence they need to make confident decisions about the road ahead. We start with a foundation of integrity in all we do, bring a spirit of discovery to our work, and collaborate in close partnership with each other and our customers to achieve shared goals. Benefits: We take care of you, so you cantake care of business. We care about our people. Thats why we provide everything youand your careerneed to thrive at S&P Global. Health & WellnessHealth care coverage designed for the mind and body. Continuous LearningAccess a wealth of resources to grow your career and learn valuable new skills. Invest in Your FutureSecure your financial future through competitive pay, retirement planning, a continuing education program with a company-matched student loan contribution, and financial wellness programs. Family Friendly PerksIts not just about you. S&P Global has perks for your partners and little ones, too, with some best-in class benefits for families. Beyond the BasicsFrom retail discounts to referral incentive awardssmall perks can make a big difference. For more information on benefits by country visithttps://spgbenefits.com/benefit-summaries Global Hiring and Opportunity at S&P Global: At S&P Global, we are committed to fostering a connected andengaged workplace where all individuals have access to opportunities based on their skills, experience, and contributions. Our hiring practices emphasize fairness, transparency, and merit, ensuring that we attract and retain top talent. By valuing different perspectives and promoting a culture of respect and collaboration, we drive innovation and power global markets. ----------------------------------------------------------- Equal Opportunity Employer S&P Global is an equal opportunity employer and all qualified candidates will receive consideration for employment without regard to race/ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, military veteran status, unemployment status, or any other status protected by law. Only electronic job submissions will be considered for employment. If you need an accommodation during the application process due to a disability, please send an email to EEO.Compliance@spglobal.com and your request will be forwarded to the appropriate person. US Candidates Only The EEO is the Law Poster http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf describes discrimination protections under federal law. Pay Transparency Nondiscrimination Provision - https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf ----------------------------------------------------------- 203 - Entry Professional (EEO Job Group) (inactive), 20 - Professional (EEO-2 Job Categories-United States of America), FINANC202.1 - Middle Professional Tier I (EEO Job Group)

Role: Chemist / Sr Chemist Department: Production Location: Bidar About Us: Sai Life Sciences is one of the fastest-growing Contract Research, Development, and Manufacturing Organizations (CRDMOs). As a pure-play, full-service partner, we collaborate with over 300 global innovator pharma and biotech companies to accelerate the discovery, development, and commercialization of their NCE programs. We have over 3000 employees across our facilities in India, the UK, and the USA, working together to deliver scientific excellence and customer success. We are a Great Place to Work certified organization with a culture of openness, mutual respect, and inclusivity. We embrace diversity and follow equal opportunity practices across all levels. Summary of Job: To execute the production through the various stages of manufacturing as per the plan and ensure compliance to quality, safety & regulatory requirements. Key Responsibilities : Execute production batches as per plan. Preparation of SOPs. To maintain the yield of products in specifies limits at various stages of process activities. Online verification of cleaning area / equipment and completion of Logs. Online monitoring of environment conditions and completion of Logs. To comply with cGMP standard during the entire process activity. Manufacturing of products as per cGMP. Online completion of batch process records. To maintain the process facility as per the regulatory norms. Experience/Qualification: M.Sc/ B.Sc/ B.Tech/ Diploma (Chemistry/Chemical) with 2-8 years of relevant industry experience. Key Competencies (Technical, Functional & Behavioural): Sound knowledge on theoretic aspects of Chemical Engineering Basic knowledge of API process and handling production machinery of manufacturing. Good interpersonal Skills

Position Assistant Manager-QA Function QA Location Bharuch;;;;;;; Reports to Head QA Summary of Job (Purpose/ objective of the job Department organogram to be enclosed) To check the Quality Assurance of the products and ensure compliance with the SOP's. Key Responsibilities (Performance Indicators) Quality professional of progressive experience with strong knowledge of Speciality Ingredient, Bulk Chemicals, Food additive/ Food supplement and API Manufacturing, Quality Management System (QMS), Qualification, Validation and other Manufacturing functions.; Documentation and Handling i.e.: Integrated Management System (IMS) (ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018), WHO-GMP, FSMS (ISO 22000), FAMI-QS, Energy Management System (EnMS), Halal, Kosher and Responsible Care and regulatory (FDCA, USFDA, MHRA).; Expertise in change control, deviation, market complaint, non-conformance investigation, vendor audit, self-inspection, gap assessment, customer audit, training, vendor management, vendor questionnaire, validation, equipment and utility system qualification. Issuance and retrieval of Batch Manufacturing Records. Control and Issuance of formats. Ensure that retention of various documents, reports and records are as per documented procedures. Issue copy of Master Batch Production Instructions to production for batch manufacture and review critical control parameters before release of the batch. No. of Reportees NA Qualification and Experience M.Sc Organic Chemistry with 3-6 yrs Key; Competencies ( Technical, Functional and Behavioral) Integrated Management System (IMS) (ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018), WHO-GMP, FSMS (ISO 22000), FAMI-QS, Energy Management System (EnMS), Halal, Kosher and Responsible Care and regulatory (FDCA, USFDA, MHRA). Knowledge of validation process. Practical experience in documentation as per various audits. Approval VP - Mfg Unit HR

Hiring QA & RA with an leading IVD Company in Hyderabad Exp: 6+ Yrs in QA & RA, ISO 13485 Mandatory Stability & immediate joiner with Biotech background Candidate With medical Device background can apply share resume at sarika.bhandari@acumont.com

Head of Engineering & Maintenance- will lead all engineering and maintenance operations for a large-scale API pharmaceutical plant. This role is responsible for ensuring the optimal performance, reliability, and compliance of plant equipment, systems, and facilities. The position requires extensive experience in API manufacturing, including expertise in CGMP, FDA regulations, and managing regulatory audits. Develop and execute maintenance strategies, drive continuous improvement, manage OPEX budgets, and lead a high-performing team to ensure safe, efficient, and compliant plant operations. LOCATION: Digwal, Hyderabad REPORTING STRUCTURE: Reports to Global Engineering & Project head & Site head , Direct reportees all plant engineering & maintenance team ESSENTIAL QUALIFICATION: Bachelors degree in Engineering (Mechanical, Electrical, or related field) RELEVANT EXPERIENCE: > 20 years in a Pharmaceutical API Facility Leadership & Strategy: Lead, manage, and develop the Engineering & Maintenance team to drive plant operational excellence. Develop and execute a comprehensive maintenance strategy, ensuring a proactive approach to maintenance, asset integrity, and equipment reliability. Drive continuous improvement initiatives to optimize plant performance and reduce unplanned downtime. Manage operating expenditure (OPEX) budgets for Engineering & Maintenance activities. Maintenance & Reliability Management : Ensure all critical equipment and systems are maintained in optimal condition to meet production goals and regulatory requirements. Oversee the implementation of preventive and predictive maintenance programs, improving plant uptime and reliability. Develop and implement a comprehensive asset management strategy, including lifecycle management for critical equipment. Regulatory Compliance & Safety : Ensure all maintenance activities are compliant with GMP, FDA, and other relevant pharmaceutical regulations. Promote a culture of safety and adherence to the highest environmental, health, and safety (EHS) standards. Lead the investigation and resolution of any maintenance-related incidents, ensuring timely and effective corrective actions. Team Development & Talent Management : Mentor, train, and develop Engineering & Maintenance personnel, ensuring their skills and capabilities meet the evolving needs of the plant. Foster a culture of collaboration, teamwork, and continuous learning within the team. Lead recruitment efforts to fill skill gaps within the department and drive talent development initiatives. Collaboration & Cross-Functional Coordination : Work closely with Production, Quality, and Supply Chain departments to ensure alignment between maintenance schedules and production plans. Collaborate with the plant leadership team to identify opportunities for process optimization, cost reductions, and productivity improvements. Technology & Innovation : Identify and implement new technologies that improve equipment performance, reduce maintenance costs, and enhance production efficiency. Stay current with industry best practices, technology advancements, and emerging trends in pharmaceutical manufacturing and maintenance Key Competencies: Must have extensive experience in API pharmaceutical manufacturing, with a deep understanding of CGMP, FDA regulations, and other regulatory audit requirements. Expertise in ensuring compliance with these standards while optimizing maintenance strategies and driving operational improvements is essential. The role requires a strong track record in managing audits, addressing non-conformities, and maintaining a high standard of product quality and safety.

Job Description Candidate should the exposure for handling the Bottle packing line. Should have the work experience in Regulatory plant. Faced the USFDA, MHRA,TGA inspection. Good Communication skill. Having the SAP knowledge. Work Experience 3 to 05 years' Experience. Education Graduation in Pharmacy Competencies

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture 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 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for any graduation Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Why join AliveCor ? At AliveCor, we imagine a healthier world powered by access to personalised intelligent information. Were on a mission to be the world s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical ECG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, millions of users have taken more than 200 million heart health measurements and counting. Our vibrant team of people are attracted to AliveCor because they want to build something meaningful -- and AliveCor delivers: every day, customers tell us that we ve saved lives. Join us in our mission! The Opportunity: AliveCor seeks a Senior Regulatory Affairs Specialist to join this exciting start-up that is changing the face of mobile health. In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction. You will work closely with Quality, Engineering, Product Management, Marketing and Sales teams to manage product submissions, perform regulatory pre- and post-market analysis, drive product registrations and listings worldwide, and help implement and maintain an ISO 13485 and FDA compliant Quality Management System. If you have what it takes to drive change in the medical marketplace, then this is the opportunity for you. Role & Responsibilities Collaborate and execute regulatory strategies for US, Europe and other global registrations Participate in preparation and review of global regulatory submissions Support government/FDA interactions pertaining to medical device registrations and licensing ; Participate in the development of regional regulatory strategy and update strategy based upon regulatory changes; Assist in the review of advertising and promotional materials; Provide regulatory support to cross-functional product development and project teams throughout the product lifecycle; Support or lead regulatory activities required for US FDA, EU MDR, NMPA, PMDA, ANVISA compliance ; Support worldwide resellers and distributors with product registrations and renewals; Provide regulatory assessment for manufacturing and design changes; Provide regulatory review and approval of change order packets; Support or lead product regulatory intelligence and risk assessments; Assist in maintaining compliance with product post market requirements; Support post-market regulatory actions taken for the products; Support internal and external audits; Ensure compliance with internal procedures and external regulations and standards; Maintain regulatory and quality records and other controlled documents; and Promote a culture of quality throughout AliveCor Requirements Bachelors degree in Science, Engineering, Math, or medical field or equivalent educational experience pertaining to technical writing, scientific method, and problem solving 4+ years of experience in medical device Regulatory Affairs Experience in regulatory affairs for software devices with AI/machine learning algorithms (SaMD) Participated in the preparation of pre-submissions, 510(k)s or de novo submissions Experience with and knowledge of EU Medical Device Regulations Ability to manage small projects: organised, independent, and results-oriented Superb analytical and excellent communication skills, strong team ethic, and attention to detail Preferred candidate profile Advanced degree or Regulatory Affairs Certification from RAPS Process-oriented thinking Supported or lead international submissions (preferably in Asia-Pacific and/or LATAM) Demonstrated competence documenting technical information and communicating it to others Perks and benefits We strive to make your life outside work as smooth as possible while you're at work, and we offer a long list of benefits to make that happen. Hybrid working model Flexible and generous vacation policy Maternity / Paternity Leave/ Adoption/ Commissioning leave Generous Medical Benefits Above market family floater medical insurance coverage including both parents or in law parents Metro connectivity from office A supportive, collaborative group of people who understand that success depends on the team

The reputed pharmaceutical company engaged in development, manufacturing and marketing of oral solid dosages forms in regulated market. We are looking for competent, growth-oriented professional in Quality Assurance and Quality Control profiles for our USFDA & EU-GMP approved OSD manufacturing facility at N-32, Additional Patalganga MIDC, Tal.- Panvel, Dist.- Raigad.Roles and Responsibilities Ensure compliance with cGMP guidelines during formulation development, solid oral manufacturing, and OSD production. Conduct analytical method validation, stability studies, and quality control activities to ensure product quality. Develop and maintain documentation for batch records, test results, and equipment calibration schedules. Collaborate with cross-functional teams to resolve issues related to process deviations and CAPAs (Corrective Action Preventive Actions). Participate in audits conducted by regulatory agencies such as USFDA. Desired Candidate Profile 3-7 years of experience in pharmaceutical industry with expertise in formulation development, solid orals, OSDs, QC/QA/Qc/quality assurance/quality control. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma) from a recognized institution. Strong understanding of GMP regulations and industry standards for pharmaceutical manufacturing.

The reputed pharmaceutical company engaged in development, manufacturing and marketing of oral solid dosages forms in regulated market. We are looking for competent, growth-oriented professional in Quality Assurance and Quality Control profiles for our USFDA & EU-GMP approved OSD manufacturing facility at Patalganga MIDC, Tal.- Panvel, Dist.- Raigad.Roles and Responsibilities Ensure compliance with cGMP guidelines during formulation development, solid oral manufacturing, and OSD production. Conduct analytical method validation, stability studies, and quality control activities to ensure product quality. Develop and maintain documentation for batch records, test results, and equipment calibration schedules. Collaborate with cross-functional teams to resolve issues related to process deviations and CAPAs (Corrective Action Preventive Actions). Participate in audits conducted by regulatory agencies such as USFDA. Desired Candidate Profile 3-7 years of experience in pharmaceutical industry with expertise in formulation development, solid orals, OSDs, QC/QA/Qc/quality assurance/quality control. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma) from a recognized institution. Strong understanding of GMP regulations and industry standards for pharmaceutical manufacturing.

The Apex Group was established in Bermuda in 2003 and is now one of the worlds largest fund administration and middle office solutions providers. Our business is unique in its ability to reach globally, service locally and provide cross-jurisdictional services. With our clients at the heart of everything we do, our hard-working team has successfully delivered on an unprecedented growth and transformation journey, and we are now represented by over circa 13,000 employees across 112 offices worldwide.Your career with us should reflect your energy and passion. Thats why, at Apex Group, we will do more than simply empower you. We will work to supercharge your unique skills and experience. Take the lead and well give you the support you need to be at the top of your game. And we offer you the freedom to be a positive disrupter and turn big ideas into bold, industry-changing realities. For our business, for clients, and for you The Role: Understand the global outsourcing policy and framework and support the Global Outsourcing Team in ensuring the business comply with this and supporting in annual refresh of policy and process. To join regular calls and meetings with the Global Outsourcing Team to shadow and learn the business and operating model from an outsourcing perspective. Support the regulated businesses across Apex with maintenance of the Nexus Assurance Navigator system. Take responsibility and ownership of Nexus Navigator and validation and integrity of data within. Work with various technology stakeholders across the business to ensure there is accurate and seamless data feeds and support with development of reporting in and out of the platform. At as project manager for any system, data or reporting projects and initiatives Support the regulated businesses across Apex with Outsourcing tasks within the platform Perform analytics on data outputs Create reports from excel outputs and support with development of dashboards to present data Support the India Outsourcing Lead, GSC and local businesses with maintenance of the Nexus Assurance Navigator system and to support with preparation of reports. Support the India Outsourcing Lead and Local MGT with amending, preparing and reviewing outsourcing spreadsheets Support the India Outsourcing Lead and Local MGT with signing of all outsourcing documents and uploading into the system Support with Nexus Assurance on-going development and system enhancement projects. Act as super user on Nexus, providing support globally and over time supporting with delivering training and guidance on the system Support with various outsourcing projects with internal stakeholders. Maintaining outsourcing registers in excel and on systems. Preparing and presenting quarterly and ad-hoc reporting packs. Assisting in audits including internal audits and risk assessments and reviews from an outsourcing perspective. Maintaining and updating trackers internally and ensuring data integrity and confidentiality of internal information. Be a member of the Global Outsourcing working group and take part in joining each of the initiatives/project teams that this group are tasked with. Preparation of annual due diligence reports Quality assurance and control The Skills: Strong communication and drafting skills including drafting of presentations and reports and supporting in writing policies and procedures Ability to learn and grasp new compliance/risk/regulatory concepts and understanding these across multiple global jurisdictions within the business. Strong work ethic. Adapting and flexible approach towards learning new systems and operational procedures. Ability to work under pressure and tight timelines, excellent time management and multi-tasking skills. Strong interpersonal, verbal and non-verbal communication skills. Team Player with excellent collaborative, analytical, problem solving and organisational skills. Result oriented, detail oriented, team player with ability to work effectively with minimum supervision, in a fast paced, complex and dynamic environment. Very strong MS Office skills (including MS Excel Outlook, MS Word, MS PowerPoint) DisclaimerUnsolicited CVs sent to Apex (Talent Acquisition Team or Hiring Managers) by recruitment agencies will not be accepted for this position. Apex operates a direct sourcing model and where agency assistance is required, the Talent Acquisition team will engage directly with our exclusive recruitment partners.

Job details: Role: Sr. Member - Corporate Quality Assurance Direct Reporting: Sr. Expert - Corporate Quality Assurance Level: MD 6 Function: Quality Location: Pune - Hinjewadi Phase 2 Job Purpose and Scope Responsible for implementing the activities for the management of CQA Accountabilities Indicator: CQP Management FSSAI Facility Licensing of Food Business in FOSCOS System. Regulatory Gap analysis and interpretation of Nutraceuticals. Regulatory Compliance for 21 CFR, FSANZ, EU, US and ROW Regulations and Standards for Food and Nutraceutical. Quality and Food Safety Key Accountabilities: Regulatory Assessment: Responsible for Regulatory Compliance check for food/ Nutraceutical industry and perform Gap identification for US, EU and ROW market. To perform GAP identification in Nutraceutical industry for updated Food safety regulation for various market. Liasoning with internal and external stakeholders on implementation and development of regulatory notification and supporting cross functions with their queries related to regulations for various market related to food/ Nutraceutical market. Provide technical review of data or report that will be incorporated into regulatory Submission. FSSAI and related Activity: Coordinating with FSSAI authorities/ Consultancy related to FSSAI compliances, license renewal and modification or any FSSAI updates or resolving queries, etc. Responsible for FSSAI Facility Licensing of Food Business in FOSCOS System. CQP Management Requirement for Food Business Ensure that the sites are ready for enabling audits and compliances. Qualification,Experience & Skills Education: Graduate/ postgraduate in pharmacy/ chemistry/ food tech with regulatory exposure. Experience: 2-4 years of work experience in the field of Quality Assurance of Pharmaceutical /Food Industry. Skills & Competencies: Awareness of regulatory requirements Communications skills Problem solving Exposure to regulatory audits like USFDA/ MHRA etc and certifications like BRC/ FSSC etc

Job Description: Head of Quality Experience: 15 Years or more Location: Udaipur About Macsen Drugs: Macsen Drugs is a USFDA registered, WHO-GMP certified, TGA GMP certified, and EU GMP (Written Confirmation) certified manufacturer of active pharmaceutical ingredients or bulk drugs for varied therapeutic applications like antidote, urinary antiseptic, topical antiseptic, ophthalmic diagnostic, anti-dandruff, anti-acne, and several other applications. Job Overview: We are seeking an experienced and detail-oriented individual to perform research activities as designing and conducting scientific experiments, analyzing and interpreting results, leading to significant value to the process development. Efficient contribution to the overall success of the research & development team performance according to objectives and targets set by the Management. Responsibilities: 1. Quality Assurance (QA) Develop and implement a comprehensive Quality Management System (QMS) compliant with cGMP and ICH guidelines. Review and approve quality documents such as SOPs, batch records, deviations, and CAPA reports. Ensure the site is prepared for regulatory audits and inspections from the USFDA, EMA, WHO, and other agencies. Conduct internal audits and self-inspections to maintain quality standards. 2. Quality Control (QC) Oversee laboratory operations, ensuring raw materials, intermediates, and finished products meet established quality specifications. Manage analytical method validations and stability studies. Monitor calibration and maintenance of laboratory instruments. 3. Regulatory Affairs Prepare and submit regulatory documents, including DMFs, for US and international markets. Address regulatory queries and implement corrective actions for observations from audits or inspections. Stay updated on global regulatory trends and ensure compliance with evolving requirements. 4. Production Oversight Collaborate with production teams to ensure manufacturing processes align with quality standards. Oversee cleaning and process validation for a multi-product facility to prevent cross-contamination. Troubleshoot production and analytical challenges in coordination with R&D. 5. Data Integrity and Security Ensure compliance with 21 CFR Part 11 for electronic records, signatures, and data integrity. Establish protocols for data security and governance across all quality operations. 6. Cross-Functional Coordination Work with R&D and Analytical Development Labs for seamless technology transfer and method development. Collaborate with Stores and Maintenance teams to ensure proper inventory management and equipment validation. Coordinate training programs for team members to maintain high-quality standards. 7. Leadership Lead and mentor teams across QA, QC, Regulatory, Production, and Maintenance departments. • Foster a culture of quality, accountability, and continuous improvement. 1. Educational Qualifications Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific field. Additional certifications in Quality Management Systems (e.g., ISO 9001, Six Sigma) are preferred. 2. Experience Requirements Minimum 15 years of experience in API manufacturing, with at least 5 years in a leadership role managing QA, QC, and Regulatory Affairs. Proven experience in handling audits and inspections by regulatory agencies such as USFDA, EMA, WHO, or PICS. Hands-on experience in managing multi-product facilities with cleaning and process validation expertise. How to Apply: Send your updated resume to hrd@macsenlab.com

We are hiring for the role FSQA Specialist Roles and Responsibilities: Inspect incoming rice and other food products for quality parameters such as moisture content, foreign matter, broken grains, and discoloration . Ensure strict compliance with internal quality standards , customer specifications, and regulatory requirements (USDA, FSSAI, etc.). Monitor and maintain food safety programs including HACCP, GMP, and sanitation protocols . Review and validate supplier documents like Certificates of Analysis (COA), test reports, and compliance records. Maintain accurate quality inspection reports , non-conformance records, and documentation logs. Collaborate with procurement and supplier teams to resolve quality issues and implement sourcing improvements. Coordinate with warehouse and operations teams to ensure correct storage and handling of rice and food products. Support internal and external audits , regulatory inspections, and product traceability activities . Provide technical assistance for product trials and ongoing quality improvement initiatives . Conduct training for internal teams on quality parameters, sampling techniques, and food safety protocols. Preferred Education and Experience: Bachelor's Degree in Food Science, Agriculture, Microbiology, or a related field. 2+ years of experience in Food Quality Assurance , preferably in rice, grains, or related food categories. Knowledge of rice grading standards (USDA, AGMARK, or equivalent). Hands-on experience with food safety systems such as HACCP, GMP, BRC, or FSSC 22000. Understanding of lab testing procedures and basic analytical instruments. Strong skills in report writing, documentation, and communication . Willingness to travel occasionally to supplier facilities or warehouses. Exposure to handling other food categories such as spices, frozen vegetables, snacks, and sauces is preferred. Familiarity with FSSAI and USFDA regulations applicable to food products. Experience in vendor audits , complaint handling, and supplier management. Competence in lab handling, quality control inventory , and sample management.

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years Language - Ability: English(International) - Intermediate About Accenture 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 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture 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 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for contract conversion Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture 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 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Good Communication skills and Any degree expect BE & B.TechGood Communication skills and Any degree expect BE & B.Tech Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Provider Network - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture 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 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Any graduate with some Health care experienceAny graduate with some Health care experience Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture 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 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for Ability to meet deadlinesAbility to perform under pressureAbility to work well in a teamAdaptable and flexibleAgility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Supriya life science ltd is looking for Manufacturing Officer to join our dynamic team and embark on a rewarding career journey. Production Management : Oversee the entire production process, including scheduling, resource allocation, and production planning. Quality Control : Implement quality control measures to ensure products meet established standards and specifications. Process Optimization : Continuously assess and improve manufacturing processes for efficiency, cost reduction, and waste minimization. Inventory Management : Manage raw materials, work - in - progress, and finished goods inventory to ensure smooth production flow and prevent shortages or overstocking. Safety Compliance : Ensure that manufacturing operations comply with safety regulations and implement safety protocols to protect workers and equipment. Equipment Maintenance : Oversee equipment maintenance, repair, and calibration to ensure proper functioning and minimize downtime. Staff Management : Supervise and manage production staff, providing guidance, training, and performance evaluations. Cost Control : Monitor production costs, identify cost - saving opportunities, and manage the budget for the manufacturing department. Lean Manufacturing : Implement lean manufacturing principles to reduce waste, improve productivity, and enhance overall efficiency. Continuous Improvement : Promote a culture of continuous improvement and innovation within the manufacturing process. Production Scheduling : Develop and manage production schedules to meet demand and delivery deadlines.

We are looking DM RA with leading pharma company in Thane. Experience in Injectable regulatory affairs pre approval & post approval experience is must. Regulatory Submissions New Project Assignment This role involves the assignment and management of new projects for regulatory submissions, playing a pivotal part in the preparation and timely submission of high-quality regulatory documents across the US, EU, UK, and Emerging Markets. The position demands a strong understanding of global regulatory requirements, excellent communication skills, and effective cross-functional collaboration to ensure successful outcomes. Educational Qualifications Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related scientific discipline Diploma in Regulatory Affairs preferred Technical and Professional Expertise Demonstrated experience in regulatory affairs with a focus on submissions for the US, EU, UK, and Emerging Markets Solid understanding of ICH guidelines, ASEAN CTD requirements, and eCTD publishing standards Practical experience in the preparation, review, and submission of regulatory documents Familiarity with Quality by Design (QbD) principles and data trend analysis Experience 5 to 10 years of relevant experience in regulatory affairs Key Personal Attributes Excellent verbal and written communication skills Strong interpersonal and collaboration abilities Capable of working independently and managing multiple projects simultaneously Domain and Functional Competencies In-depth knowledge of international regulations (e.g., FDA, EMA, ICH) Up-to-date with evolving regulatory frameworks and compliance requirements Proficient in compiling,reviewing, and submitting comprehensive regulatory dossiers Ensures completeness, accuracy, and adequacy of all documents required for product approvals

We are seeking a dynamic and experienced candidate to lead and manage the overall operations of our sterile injectable manufacturing plant. The ideal candidate will be responsible for ensuring seamless plant operations, regulatory compliance, quality standards, and people management while driving productivity and efficiency. About the Responsibilities Strategic Leadership: Lead the end-to-end operations of the sterile injectable plant, including production, quality, engineering, supply chain, and EHS functions. Regulatory Compliance: Ensure full compliance with internal and external regulatory standards (e.g., EU-GMP, WHO-GMP) and corporate SOPs. Operational Excellence: Drive continuous improvement in manufacturing efficiency, cost optimization, and product quality. Oversee the implementation of digitalisation, such as optical inspection and serialisation. People Management: Build and lead a high-performing cross-functional team. Foster a culture of accountability, safety, and innovation. Project Execution: Oversee capacity expansion, technology transfer, and commissioning of new lines (e.g., lyophilization, isolator-based filling systems). Stakeholder Engagement: Collaborate with corporate leadership, regulatory bodies, and cross-functional teams to align plant goals with organizational objectives.

Job Area: Finance & Accounting Group, Finance & Accounting Group > Global Accounting Ops Center General Summary: Job Overview The EMEA Payroll Staff will support the Qualcomm EMEA Payroll function, its processes, and internal or external relationships with General Accounting, Human Resources, Legal, Benefits, Employee Relations, Stock Programs, IT, Tax Auditors, ADP, and other related entities. This position will be responsible for developing, implementing, and maintaining processes that will contribute to efficient payroll processing for 5,000+ employees across multiple EMEA countries. This position will report to the Payroll Manager, located in Hyderabad, and will be responsible for coaching and guiding junior team members. The ideal candidate for this position is a people manager with 12+ years of experience, including a minimum of 3+ years in people management. We are looking for an individual with demonstrated experience in multi-country accurate and timely payroll processes who can effectively communicate with a global team. Responsibilities Own the operations of EMEA payroll for countries such as the UK, Ireland, France, Sweden, Netherlands, etc. This may include directly managing the EMEA payroll teams processing of monthly payroll, including ESPP and RSU stock reporting, benefits, tax, and social insurance requirements and reporting Timely review and first approval of multiple monthly payrolls for the accuracy, completeness and compliance Ensure compliance in operational controls around critical payroll processes such as new hires, terminations, and one-time payments Collaborate closely with the global payroll team and payroll partners on payroll processing, department initiatives, and projects Analyze payroll processes and controls, identify opportunities for improvement, and ensure global process consistency where applicable Liaise with external auditors and manage payroll-related audits Perform other special projects and analyses as directed by management Keep an eye on payroll KPIs and lead from front to improve them Minimum Qualifications Bachelors degree or equivalent foundation degree Certified Payroll Professional certification- good to have 10-12 years of total EMEA country payroll experience Demonstrable experience of mentoring junior team members Experience working in a multinational organization Expert skills with ADP Global View and Workday Excellent understanding of payroll systems, data workflows, and root cause analysis Current knowledge of applicable tax, social security, and other compliance requirements across multiple EMEA countries Fluent in spoken and written English Knowledge of taxable and non-taxable earnings and expenses; payroll tax laws and complex employee benefit programs impacting payroll Proven experience in designing and implementing processes, controls, and systems Solid understanding of equity-related transactions (RSU, ESPP gain) Ability to handle multiple tasks, set priorities, and meet deadlines in a high-volume, fast-paced environment High degree of accuracy, attention to detail & strong Excel and numerical skills Strong knowledge of payroll accounting and reconciliations Outstanding written and oral communication, organizational, and leadership skills Preferred Qualifications Masters degree in accounting Proficiency in French or any other European language Hands-on payroll knowledge of France, Sweden, and UK payrolls Any payroll certification is a plus End-to-end project experience with ADP Global View implementation Exposure or experience in mergers and acquisitions Minimum Qualifications: Bachelor's degree. 6+ years of Finance, Accounting, or related work experience.*Completed advanced degrees in a relevant field may be substituted for up to two years (Masters = one year, Doctorate = two years) of work experience. Job Overview The EMEA Payroll Staff will support the Qualcomm EMEA Payroll function, its processes, and internal or external relationships with General Accounting, Human Resources, Legal, Benefits, Employee Relations, Stock Programs, IT, Tax Auditors, ADP, and other related entities. This position will be responsible for developing, implementing, and maintaining processes that will contribute to efficient payroll processing for 5,000+ employees across multiple EMEA countries. This position will report to the Payroll Manager, located in Hyderabad, and will be responsible for coaching and guiding junior team members. The ideal candidate for this position is a people manager with 12+ years of experience, including a minimum of 3+ years in people management. We are looking for an individual with demonstrated experience in multi-country accurate and timely payroll processes who can effectively communicate with a global team. Responsibilities Own the operations of EMEA payroll for countries such as the UK, Ireland, France, Sweden, Netherlands, etc. This may include directly managing the EMEA payroll teams processing of monthly payroll, including ESPP and RSU stock reporting, benefits, tax, and social insurance requirements and reporting Timely review and first approval of multiple monthly payrolls for the accuracy, completeness and compliance Ensure compliance in operational controls around critical payroll processes such as new hires, terminations, and one-time payments Collaborate closely with the global payroll team and payroll partners on payroll processing, department initiatives, and projects Analyze payroll processes and controls, identify opportunities for improvement, and ensure global process consistency where applicable Liaise with external auditors and manage payroll-related audits Perform other special projects and analyses as directed by management Keep an eye on payroll KPIs and lead from front to improve them Minimum Qualifications Bachelors degree or equivalent foundation degree Certified Payroll Professional certification- good to have 10-12 years of total EMEA country payroll experience Demonstrable experience of mentoring junior team members Experience working in a multinational organization Expert skills with ADP Global View and Workday Excellent understanding of payroll systems, data workflows, and root cause analysis Current knowledge of applicable tax, social security, and other compliance requirements across multiple EMEA countries Fluent in spoken and written English Knowledge of taxable and non-taxable earnings and expenses; payroll tax laws and complex employee benefit programs impacting payroll Proven experience in designing and implementing processes, controls, and systems Solid understanding of equity-related transactions (RSU, ESPP gain) Ability to handle multiple tasks, set priorities, and meet deadlines in a high-volume, fast-paced environment High degree of accuracy, attention to detail & strong Excel and numerical skills Strong knowledge of payroll accounting and reconciliations Outstanding written and oral communication, organizational, and leadership skills Preferred Qualifications Masters degree in accounting Proficiency in French or any other European language Hands-on payroll knowledge of France, Sweden, and UK payrolls Any payroll certification is a plus End-to-end project experience with ADP Global View implementation Exposure or experience in mergers and acquisitions Applicants Qualcomm is an equal opportunity employer. If you are an individual with a disability and need an accommodation during the application/hiring process, rest assured that Qualcomm is committed to providing an accessible process. You may e-mail or call Qualcomm's toll-free number found . Qualcomm expects its employees to abide by all applicable policies and procedures, including but not limited to security and other requirements regarding protection of Company confidential information and other confidential and/or proprietary information, to the extent those requirements are permissible under applicable law. To all Staffing and Recruiting Agencies Please do not forward resumes to our jobs alias, Qualcomm employees or any other company location. Qualcomm is not responsible for any fees related to unsolicited resumes/applications. If you would like more information about this role, please contact .

Role & responsibilities : Act as the lead internal auditor for medical device programs, ensuring compliance with ISO 13485 and U.S./EU regulations. Investigate non-conformances and implement effective corrective actions for medical device-related issues. Review onboarding checklists to ensure FDA and EU MDR requirements are met for all devices. Oversee compliance in shipping, labeling, and depot processes for investigational and commercial devices. Serve as the main contact during ISO 13485 audits and coordinate with logistics and external auditors. Monitor regulatory changes (FDA, EMA, MDR) and update quality systems accordingly. Administer the EDMS platform, managing system operations, user support, and maintenance. Manage controlled document lifecycles, ensuring version control, timely reviews, and audit readiness. Promote compliance awareness across delivery teams and collaborate with cross-functional stakeholders. Demonstrate strong problem-solving, communication, and virtual collaboration skills, with the ability to explain risk to non-technical teams. Required Experience and Educational Qualification: 10+ years of experience in medical device compliance or quality roles within the pharma, biotech, or medical device industry. Proven expertise in ISO 13485 implementation, audit participation, and regulatory compliance. Solid understanding of FDA 21 CFR Part 820, EU MDR (Regulation (EU) 2017/745), and international medical device standards. Experience with depot and shipping logistics for clinical or commercial medical devices. Strong analytical, documentation, and communication skills. Familiarity with EU authorized representative and UDI requirements. Knowledge of document control processes in support of GxP operations (GMP, GVP, GCP). Familiarity with change control, IT compliance, and CAPA systems.