111 Quality Review Jobs

YOUR TASKS AND RESPONSIBILITIES: This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical Trial Supply Management (CTSM) team, and Clinical Data Management team by way of Review of all study related activities, processes, procedures and adherence to applicable regulations and guidelines to ensure 24x7 Inspection/audit readiness. This role will be responsible for establishing the procedures and trainings of teams which ensure protection of human subjects from research risk, reliability/Integrity of the data, and thereby assures internal consistency and Quality Compliance measures. Systems and Processes: Develop, implement and maintain a Quality Management System (QMS) for clinical trial team in consultation with Head Quality Compliance & Training and ensure oversight on team on quality aspect as per defined SOPs and applicable regulations. Implement and oversee the Quality Compliance procedures/processes/systems for clinical trials managed by the Medical science and Clinical Operations department. To assist in designing a process to write, review and approve the risk assessments for new trials and for ongoing projects and working closely with Project Managers and Operation Head as needed. To ensure a process in place to provide assurance on review of all study documentation for accuracy, consistency and completeness. Ensure effective systems and processes in place to maintain consistency and quality compliance parameters in medical science, operations, data management and drug depot for end-to-end activities of each function as per applicable regulatory requirements. Work with Clinical Research QC team, Medical Science team, Clinical Operations team, Clinical Data Management team and Study Management team to create and implement study specific QC plans that outline the scope of Quality Compliance procedures to be followed during clinical trials, ensuring QC processes are in alignment with SOPs and study protocols. Ensure completeness of training of study team on SOPs and job specific training as per role and responsibilities. Ensure periodic review of training files for all study team. Assess and identify the training requirement of study team and ensure completion of training. Well versed with electronic systems used in Clinical Trial operations, Data Management and Project Management which includes project specific deliverables tracking and important milestone related alarms, protocol compliance tracking, deviations tracking and electronic systems used for managing Trial Master File (TMF) and Drug accountability. Assist in developing system/process to work with the clinical trial team to schedule pre-execution and post-execution QC activities to ensure that all requirements of the QC plans are planned as required and executed. Plan, design, and update process and systems for clinical trial activities like development and utilization of QC assessment parameters and other QC tools designed to document/track the QC review process for clinical research activities in line with recent regulatory requirement. Ensure Quality Management System at Medical Science, Data Management team, Operation team to ensure the department is ready for audit/inspection 24x7. Ensure periodic review of Vendors and renewals as per applicable policies & procedures. Identify and recommend process improvement initiatives where required. Create and evaluate metrics to assess performance and implement plans for course correction. Activities: Should be effective team player who can work closely with different study teams and collaborate well with team members to achieve defined QC targets. Develop and implement a risk-based and flexible approach to Quality Compliance (QC) within the function, which will ensure that trial participants and data are safeguarded in compliance with applicable regulatory requirements and best practices. Identify and decide team members job specific SOP training requirements in view of their role and maintain oversight of training to ensure all team members are trained on each SOP as required. Preparation of SOPs related to QC function and support in review of SOPs specific to Medical science, Clinical team and Data Management team. Quality review of the clinical trial medical science related activities like Synopsis, Protocol, Clinical Study Report (CSR) and appendices, and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement. Quality review of the clinical trial operation related activities, related tools, plans and documentation like site feasibility, site selection visit, site initiation, Ethic committee documentation, monitoring site specific reports, Site Documents, logs and close out activities in line with ICH GCP requirement, Indian and global regulatory requirement. Ensure Quality review of SOPs and oversight on quality parameters specific to Clinical Trial Supply Management (CTSM) and other activities like receipt, handling of study sample, labelling, storage, temperature monitoring systems and distribution to trial sites. Final QC review of study close out activities including returned goods reconciliation, inventory destruction processing and archiving of documents. Review and communication of QC findings to respective department in stipulated timelines. Arrange monthly meeting or meetings as and when required depending on criticality of the issues with concerned team to discuss and communicate the findings from QC reviews to the internal stakeholders via QC summaries, reports as required. Maintain the repository of QC findings as per the department and specific function and present the trend analysis, training requirement and action plan with timelines to Head Medical Affairs and clinical for course correction on quarterly basis. Ensure training of SOPs, on job training and reviewing training files on regular basis. QC review and Support in preparation of clinical study manuals/documents/Plan such as the IMP handling manual, Study plans. Ensure record maintenance for all activities for traceability in line with regulatory requirement. WHO YOU ARE: > 5 years’ experience in a CRO/Pharma/Biotech organization in Quality department with experience of Quality activities in Clinical Research department. Strong eye for detail and ability to spot inconsistencies a must and good conflict management skills. Must have experience in handling audits & inspections of DCGI, US FDA. Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations and other applicable regulations pertaining to clinical trials. Experience of working in matrix business environments preferred. Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards. Quality oriented mindset and skill set. Experience in auditing processes and procedures, including the development of plans for corrective and preventive action (CAPA). In-depth working knowledge of clinical trial regulations, good clinical practice (GCP) guidelines and other frameworks, and their implications for clinical research. Proactive approach to reviewing, updating and improving processes based on current knowledge of the regulatory requirements. Have strong analytical and problem-solving skills and the ability to present solutions. Able to work under pressure and prioritize workload effectively, able to ensure timely completion of tasks to high quality in a matrix organization. Eye for details, Sense of urgency & desire to excel. Proficiency with Excel or other quality management systems/ tools. Result oriented and performance driven. Excellent interpersonal & communication skills to effectively interact with a broad range of audience.

This opportunity is only for candidates currently residing in the specified country. Your location may affect eligibility and rates. At Mindrift , innovation meets opportunity. We believe in using the power of collective intelligence to ethically shape the future of AI. What we do The Mindrift platform connects specialists with AI projects from major tech innovators. Our mission is to unlock the potential of Generative AI by tapping into real-world expertise from across the globe. About the Role Generative AI models are improving very quickly, and one of our goals is to make them capable of addressing specialized questions and achieving complex reasoning skills. As a General QA (AI Trainer) , you will help ensure the quality of prompts and outputs by reviewing tasks for language quality, guideline accuracy, and consistency. You will serve as the final quality check before work is sent to the client. Responsibilities: Prompt & Output Review: Evaluate AI prompts and responses for clarity, correctness, fairness, and compliance with guidelines. Provide feedback to ensure outputs meet high-quality standards. Content Refinement: Identify issues such as ambiguity, factual errors, formatting inconsistencies, or bias in AI outputs, and suggest improvements. Auditing Work: Review tasks completed by other contributors, ensuring they follow project guidelines. Provide constructive feedback and edit content as needed to improve quality. Chat Moderation: Provide support by addressing project-related questions from other experts in Discord chats, especially those related to project guidelines. Guideline Application: Apply quality rubrics consistently to ensure outputs align with established standards. You have a Bachelor s Degree or Master s Degree n any discipline (no specific field required). You have at least 3-5 years of professional experience in a role requiring attention to detail, critica

This position plays a role in the authoring, compilation and peer review of Amgen s Periodic Aggregate Safety Reports (PASR) e. g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e. g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. In compliance with global regulatory requirements. This role supports the end-to-end writing and documentation process and ensures timelines are met. Key Responsibilities: Compilation and authoring of PASRs Coordinate and schedule all meetings with cross-functional stakeholders to ensure effective collaboration and alignment Drive report timelines and escalate risks or delays to team leads or management Collaborate with cross-functional stakeholders and external business partners to collect PASR contributions and compile into PASR template. Author safety content for all PASRs in collaboration with Therapeutic Area Safety scientists Conduct peer QC of safety authored sections, coordinate Amgen review and resolve comments and initiate approval workflows. Maintain and archive accurate records and documentation throughout the report process. Review and approve published report versions (i. e. blinded, unblinded, EU FDA, Rest of World). Manage report distribution to Contract Research Organizations (CROs) and Business Partners (BPs) Ensure adherence to established timelines, regulatory guidelines and applicable standards, styles, guidelines and processes Peer review/quality review of all PASRs within established timelines with adherence to applicable guidelines and processes, using appropriate checklists Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards Generate PASR metrics, including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs). Literature Management Process May assist with Literature Management activities as required

Location: Coimbatore CEC Designation: Consultant Extensive client-facing consulting experience, providing tailored solutions and strategic guidance to address complex business challenges and regulatory requirements Strong problem-solving and analytical skills with the ability to address complex risk management challenges and recommend effective mitigation strategies tailored to client needs Demonstrating expertise in performing detailed vendor due diligence and overseeing all phases of third-party lifecycle assessments, ensuring alignment with organizational requirements, regulatory standards, and risk management frameworks Designing and implementing third-party risk management tools and frameworks tailored to client needs, ensuring effective risk identification, assessment, and mitigation Ability to effectively liaise with clients and manage stakeholder expectations. Work with client teams from various depts. Such as compliance teams, auditing and regulators to identify and document various requirements/obligations Conducting risk assessments and audits with respect to people, process, and technology. Identification of gaps/observations, risks, opportunities and improvement of policies, processes, procedures and standards. Documenting information security risk, recommendation, and compensating controls in the form of assessment/audit reports Collaborate with other members of the engagement team to plan and develop relevant work papers/deliverables for vendor information security reviews, define approach for vendor assessment and develop vendor evaluation model Handle key activities of assessment/ audit life cycle: planning, execution, reporting, quality review and tracking Provide guidance and share knowledge with team members and participate in performing procedures especially focusing on complex, judgmental and/or specialized issues Strong understanding of global and India-specific regulatory requirements, including RBI, GDPR, FCA, ISO standards, and their implications for compliance and risk management. Any Graduate

ApoPharma, a member of the Apotex group of companies, is a pharmaceutical company devoted to the discovery, development and provision of new medicines to help improve the quality of life of patients with debilitating and life-threatening diseases. Investigation into the pathological role of iron in human disease, and how to use novel medicines to treat conditions created or worsened by iron, is a major research focus of ApoPharma. Job Summary Coordinate with concerned department for monitoring /tracking of change control for its effective implementation and clouser of Change controlin an timely manner. Job Responsibilities Review of the MBPCRs and MGCRsfollowed by change control impact assessment pror to approval. Review of the excuted BPCRs /GCRs and Manufactiring related documentation support. To insure manufacturing documents are issued/archived as per procedure in line with manufacturing activities. To monitor and ensure the Dispatch activities initiated after the Quality release. To coordinate with the manufacturing team to address any Quality issues arises during manufacturing. To support for addressing Deviation,lnvestigation and Change control change control activity. Equipment and area clearance certification for product changeover. To perform the SAP related activities. Handling of Deviation /CAPA related to manufacturing. Preparation and review of the Protocol and report, monitoring of the Process and cleaning validation activities. Preparation and review of cleaning evaluation report. Preparation and review of annual Product Quality Review(APQR). Preparation and revision of the Departmental SOP ,Form and Annexures. Monitoring of the cGMP compliance through Plant rounds To adhere the EHS policy & procedure in routine activities. To involve in EHS related activities on need basis. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education M.Sc./ M. Pharma Experience 6-10 year experience, with demonstrated skill in preparation of protocol and reports, monitoring of process validation, etc. At ApoPharma, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. ApoPharma offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Join our dynamic Controls & Oversight team as a Quality Review and Controls Analyst, where your expertise will be crucial in understanding Access Management Group process flows and ensuring compliance. Leverage your presentation and communication skills to interact with production leaders and leadership teams. If you have a keen eye for detail and a proactive approach, you may be the perfect fit for our team. Job Summary As a Business Analyst in our Controls & Oversight team, you will be responsible for understanding Access Management Group process flows, Standard Operation Procedures, and controls. You will quickly grasp new process changes to perform effective quality reviews and control assessments. Your role involves evaluating and monitoring controls, identifying gaps, and recommending improvements. Job Responsibilities Evaluate and monitor controls to identify gaps and potential risks. Conduct quality reviews to ensure process compliance. Recommend necessary improvements for process enhancement. Present quality review and control test results in business reviews. Handle dispute management calls with stakeholders. Maintain SOPs, job aids, and process maps. Assist in developing and maintaining documentation. Own and complete assigned tasks within specified timelines. Collaborate with CFS and AMG teams for quality improvement. Stay updated on industry best practices and regulatory changes. Foster a culture of continuous focus on productivity and quality. Required Qualifications, Capabilities, and Skills Demonstrate excellent communication and interpersonal skills. Possess a strong eye for detail and work efficiently within timelines. Be self-motivated, proactive, and results-oriented. Analyze complex datasets and identify trends and patterns. Engage with business leaders to meet priorities and objectives. Take ownership of assignments with minimal direction. Hold a Bachelor s Degree or higher. Preferred Qualifications, Capabilities, and Skills Provide effective feedback on quality trends and process performance. Understand quality assurance, control testing, and issue management. Know Identity and Access Management (IAM) and access submission tools. Experience in risk management, controls testing, or quality roles. Demonstrate strong project management and analytical skills. Utilize MS Access, Excel, PowerPoint, and Word effectively. Hold professional certification in risk management.

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe. You will perform allied activities such as data collection for report planning, developing strategy, and leading kick-off meetings and round table discussions for comment resolution. Additionally, you will write various safety reports (or part of such reports) for global regulatory submissions, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Report, Risk Management Plans, and other documents. It will be your responsibility to take ownership of the assigned deliverables and collaborate with internal/client stakeholders and the client to obtain the required inputs. You will also perform quality reviews of safety reports prepared by junior or associate medical writers. Your role will involve authoring or contributing to ad hoc reports, benefit-risk evaluation reports, justification/supporting documents for label updates, and writing Common Technical Document Summaries including Non-Clinical and Clinical Overviews, Clinical Summaries, and other regulatory documents as assigned. You will also prepare medical information responses for Healthcare Providers (HCPs) and contribute to signal reports (ad hoc & periodic) and safety issue analysis reports. Writing subject narratives for adverse drug reactions and serious adverse events will be part of your responsibilities. Internal and external (client) communication and coordination to gather the necessary inputs will be essential in this role. You will participate in creating and updating labels, such as Core Data Sheets, USPI, centralized SPCs, and Med Guides. Conducting literature searches for authoring various types of reports or routine surveillance activities will also be part of your duties. Reviewing and proposing updates to search strategies and articles selected by other medical writers/junior writers will be necessary. Additionally, you will author literature abstracts/summaries and propose Company comments. You will be expected to implement and promote the use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures. Ensuring compliance of operations with governing regulatory requirements will be paramount. Creating, maintaining, and fostering a culture of high customer service will also be part of your responsibilities. Any additional activities as per the project requirement or managers" discretion upon completion of relevant training will also need to be performed. Embracing a collaborative workspace where personal growth is nurtured will enable you to make a meaningful global impact. Fortrea is actively seeking motivated problem-solvers and creative thinkers who share the passion for overcoming barriers in clinical trials. The commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Joining the exceptional team at Fortrea will provide you with the opportunity to contribute to a culture where personal growth is encouraged and where you can make a significant global impact. For more information about Fortrea, visit www.fortrea.com. Fortrea is proud to be an Equal Opportunity Employer. For more information about how personal data is collected and stored, please refer to the Privacy Statement. If you require a reasonable accommodation to complete your job application, pre-employment testing, job interview, or to participate in the hiring process due to a disability, please contact taaccommodationsrequest@fortrea.com. Please note that this email address is only for job seekers requesting an accommodation and should not be used to check the status of your application.,

You will be working at Birlasoft, a company known for its expertise in enterprise solutions and digital technologies, with a focus on driving business processes forward. As part of the CK Birla Group, you will be joining a team of over 12,500 professionals dedicated to upholding the Group's 162-year legacy. Birlasoft values Diversity, Equity, and Inclusion (DEI) initiatives, as well as Corporate Sustainable Responsibility (CSR) activities, showcasing a commitment to creating inclusive and sustainable communities. If you are passionate about technology that serves a greater purpose, this is the place for you. As a Test Lead with a specialization in manual testing with Workday, you will be responsible for reviewing client requirements and providing feedback. Your role will involve creating test plans, schedules, and strategies, while also overseeing the testing of software features and maintaining quality reviews of various applications. You will play a key role in project management, ensuring work is scheduled based on priorities, risks, and team strengths, and allocating resources effectively across projects. In addition to overseeing the implementation and execution of functional, regression, and acceptance tests, you will be involved in test environment setup, test automation, and exploratory testing. Your expertise will be crucial in providing solutions for issues/errors based on the system's understanding and client business processes. Moreover, you will lead and mentor Test Engineers, sharing knowledge to ensure the QA staff meets the technical qualifications required for their roles. Your responsibilities will extend to coaching junior staff, assisting in decision-making, problem-solving, and goal-setting, as well as providing feedback on testing-related tasks. You will collaborate with clients to evaluate and implement new technologies, offering strategies for new opportunities. Additionally, you will contribute to formulating QA standards, best practices, organizational policies, processes, and strategic plans within the organization. To excel in this role, you should have experience in testing various applications, services, and user interfaces, as well as managing a team of QA Engineers. Effective communication with clients, an understanding of test-driven development, software development lifecycle, Agile and Waterfall processes, user interface design, and software quality assurance best practices is essential. Familiarity with defect management systems will also be beneficial in fulfilling your responsibilities effectively.,

At Allucent, we are dedicated to assisting small-medium biopharmaceutical companies in efficiently navigating the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. The Clinical Data Manager I (CDM1) plays a crucial role in supporting various data management activities within the Allucent Data Management (DM) department. This position involves collaborating with other Allucent Clinical Data Managers (CDMs) and Clinical Programmer(s) to ensure the quality standards and regulatory requirements for analysis and reporting are met. Your key tasks in this role will include: - Assisting in various data management tasks and collaborating with Lead DMs and relevant roles within Data Management - Providing feedback and status updates to Lead DM regarding progress, timelines, risk, and quality - Supporting the development, review, and maintenance of project-specific DM documents - Participating in database User Acceptance Testing (UAT) related tasks - Reviewing and validating clinical data to ensure consistency, accuracy, integrity, and completeness - Supporting various data transfers and reconciliation activities - Creating training materials for EDC users - Conducting Quality Review checks during studies and documenting findings - Supporting database maintenance, lock, and close-out processes - Identifying and solving potential problems and evaluating effectiveness - Maintaining DM study documentation and ensuring all filing is up to date - Supporting internal and external audits by collecting necessary documentation - Aligning data management and clinical programming best practices within the company - Proposing and supporting initiatives for improving efficiency and contributing to staff learning and development To be successful in this role, you will need: - A degree in life science, healthcare, or a related field - Minimum 6 months of relevant work experience in data management, CRA, or clinical database programming - Basic knowledge of ICH-GCP, GDPR/HIPPA, and regulatory requirements - Experience with electronic data capture (EDC) software systems and clinical study management tools - Strong communication skills and proficiency in English language - Ability to work in a fast-paced environment and attention to detail - Proficiency in computer applications such as Word, Excel, and PowerPoint The benefits of working at Allucent include a comprehensive benefits package, competitive salaries, training budget, flexible working hours, remote/hybrid working opportunities, leadership and mentoring programs, internal growth opportunities, and more. Please note that our hybrid work policy encourages a dynamic work environment, with 2 days in the office per week for employees within a reasonable distance from our global offices. Allucent does not accept unsolicited resumes from third-party recruiters. Candidates should not be submitted directly to our hiring managers or human resources.,

As the Project Safety Specialist, your primary responsibility will be to manage client or project-specific PSS operations associated with products, including the entire adverse events process. This may involve handling safety data collected from clinical trials and/or post-marketing settings for specified projects. Your role will require you to manage and process expedited adverse events to the required standard and submit them to the client and regulatory agencies within agreed timelines. You will be providing this service to clients either as a support function to client project groups or as a stand-alone business, ensuring the delivery of high-quality service in a safe and cost-effective manner. Compliance with legal requirements such as the Health and Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3 will also be a key aspect of your role. Your responsibilities will include providing leadership and management for global or regional projects, ensuring harmonized communications and processes. You will monitor and manage project workflows to meet deadlines and ensure compliant safety reporting in accordance with international regulations and SOPs. Making decisions regarding adverse event reporting within project guidelines, working closely with clinical operations and project management groups, overseeing the receipt and processing of adverse event reports, and ensuring expedited reporting to regulatory agencies are also part of your duties. Additionally, you will be responsible for managing EudraVigilance activities, performing signal detection, and preparing pharmacovigilance reports, among other tasks. You will contribute to the development and review of various safety-specific plans, prepare and deliver safety presentations, maintain a comprehensive understanding of SOPs and guidance documents related to safety management, and provide support and training to team members. Building and maintaining good drug safety relationships, demonstrating role-specific competencies and company values, and handling financial authority related to projects will also be part of your role. To qualify for this position, you should have a minimum of 8 to 12 years of non-degree experience, preferably in disciplines such as Biological Sciences, Pharmacy, Nursing, Life Sciences, or Chemistry. Safety experience, knowledge of pharmacovigilance regulations, Good Clinical Practice, ICH guidelines, and medical and drug terminology are essential. Strong leadership, communication, and problem-solving skills, as well as the ability to work collaboratively and handle project management, are required. Preferred qualifications include EudraVigilance Certification and knowledge of Medical Device Reporting. The physical demands of this role involve working in an office environment with occasional travel required (10-15% of the time) including overnight stays as necessary. Your role will be crucial in ensuring the efficient and compliant management of safety processes and reporting for assigned projects, contributing to the overall success of the organization.,

As the worldwide leader in superior travel bags, luggage, and accessories, Samsonite combines notable style with the latest design technology and utmost attention to quality and durability. Leveraging a rich heritage of over 100 years, Samsonite creates unparalleled products catering to the travel lifestyle needs of conscious movers globally. With a diverse portfolio of brands such as Samsonite, Tumi, American Tourister, High Sierra, Gregory, eBags, Hartmann, and Lipault Paris, our products are available in over 100 countries across North America, Asia, Europe, and Latin America through company-operated retail stores, websites, and various retail partners. In this role, your major responsibilities will include conducting daily quality inspections at domestic and Bangladesh supplier sites, communicating daily audit reports to suppliers and the Samsonite sourcing team, ensuring timely closure of nonconformities in final product inspections and addressing market feedback, providing support for process improvement at supplier sites, overseeing monthly raw material and final product lab testing, conducting inspections for new product pilot runs, offering on-the-job training to new supplier QA teams, and conducting monthly quality review meetings with supplier teams. At Samsonite, we value our employees and strive to provide meaningful rewards and development opportunities, recognizing performance and fostering a supportive working environment. We are committed to fostering a vibrant and inclusive culture that welcomes individuals from all backgrounds, empowering them to bring their authentic selves and unique perspectives to work every day. Additionally, we are dedicated to social responsibility, aiming to minimize our products" environmental impact and contribute to positive global journeys through sustainable materials, methods, and models. Samsonite believes in doing more than just creating travel bags we aspire to inspire and celebrate the moments that move people. Our commitment extends to operating responsibly, selling sustainable products, contributing to local communities, and treating our employees with dignity and respect. We celebrate diversity and the different paths and passions that each professional brings to our team, fostering a workplace where individuals can thrive and contribute their best selves daily. As an equal opportunity employer, Samsonite is dedicated to maintaining a work environment where all individuals, including applicants, associates, customers, and others, are treated with dignity and respect, free from unlawful harassment, discrimination, or retaliation. Join Samsonite on a journey that goes beyond merely creating products and become a part of something bigger, exploring your passions and making a positive impact on the world.,

The role involves conducting research to identify potential vendors, comparing and evaluating offers from suppliers, and negotiating contract terms and pricing. You will be responsible for tracking orders to ensure timely delivery, reviewing the quality of purchased products, and entering order details into internal databases. It is essential to maintain updated records of purchased products, delivery information, and invoices, as well as prepare reports on purchases, including cost analyses. Monitoring stock levels and placing orders as needed, coordinating with warehouse staff for proper storage, and attending trade shows and exhibitions to stay up-to-date with industry trends are also part of the job responsibilities. This is a full-time position that includes benefits such as cell phone reimbursement and Provident Fund. The work schedule is during the day shift, and the location of work is in person.,

The responsibility of this role is to provide all clients, both internal and external, with high-quality service in a safe and cost-effective manner. You are expected to adhere to legal requirements such as the Health and Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3 as outlined in the Company's Health and Safety Manual. Your key responsibilities include: - Conducting quality reviews of assigned cases. - Compiling quality metrics based on reviews and identifying trends. - Assisting in client quality reviews and preparing corrective and preventive actions. - Ensuring implementation of CAPA results in coordination with project managers. - Reviewing various cases and safety reports for regulatory submissions and labeling documents. - Managing adverse events, product quality complaints, and medical information to meet timelines. - Participating in process reviews, designing training schedules, and contributing to process improvements. - Coordinating audits, developing Quality Management Plans, and supporting regulatory inspections. - Analyzing data, suggesting process improvement strategies, and responding to queries. - Executing drug safety data management processes and guiding safety associates. - Supporting sponsor during regulatory inspections or audits and responding to safety reports. Qualifications required for this role: - Bachelor's/Master's/PhD degree in relevant fields or equivalent experience. - Minimum of two years of experience in pharmacovigilance/safety writing. - Proficiency in medical and drug terminology, GCP, GVP requirements, ICH Guidelines, and regulatory requirements. - Technical proficiency with Microsoft Office applications. Preferred qualifications: - Experience in generating quality metrics, trend analysis, and coordinating corrective actions. - Knowledge of Medical Device reporting is desirable. Physical Demands/Work Environment: - Office environment with occasional travel required. This role offers an opportunity to contribute to quality operations, process improvements, and regulatory compliance in the pharmaceutical industry.,

As a Senior Instructional Designer based in Noida/Pune, you will be instrumental in revolutionizing learning experiences by creating innovative learning assets and engaging activities. Your primary responsibility will be to oversee training projects from inception to final approval. To excel in this role, you must possess exceptional multitasking abilities, prioritize effectively, stay organized, and manage time efficiently. A crucial aspect of this position is your capability to align and collaborate harmoniously with both internal and external stakeholders. Your duties will include analyzing client inputs to formulate project-specific questionnaires for gathering essential information, visualizing and conceptualizing the end product in accordance with the approved learning solution, developing high-level and low-level designs grounded in adult learning principles, designing game-based and simulation-based learning experiences, crafting engaging microlearning and mobile learning solutions, establishing project-specific standards and instructional design guidelines, creating storyboards for different learning levels, reviewing storyboards for instructional quality and interactive elements, assessing Alpha and Beta versions of learning assets for quality and instructional integrity, maintaining regular communication with clients and internal project teams, offering guidance and assistance to team members when necessary, mentoring junior instructional designers, staying updated with the latest trends and practices in instructional design, and documenting and sharing the learning development approach of specific projects with cross-functional teams. Minimum qualifications for this role include holding a bachelor's degree, possessing over 4 years of experience in instructional designing, particularly in corporate or higher-education sectors, being proficient in writing clear, concise, and grammatically correct content, understanding adult learning theory and its application to learning solutions, having exposure to various types of learning assets in a blended learning program, familiarity with instructional design theories and models, previous experience collaborating with Subject Matter Experts (SMEs) in a team setting, and the ability to manage multiple development projects and deadlines independently. Preferred qualifications entail having experience in designing and developing high-end learning products like business simulations, games, and videos, expertise in curriculum and program design, proficiency in reviewing storyboards, and being skilled in software applications including Articulate Storyline and/or Articulate Studio, Adobe e-Learning Suite Programs (Captivate, Photoshop, Flash), MS Office (Word, PowerPoint, Excel), Camtasia, Storyline, and Snagit. The selection process involves an assignment followed by interview rounds. A recruiter will contact you soon with further details.,

The primary responsibilities for this role include leading and coordinating the editorial process of academic journals. This involves managing peer review workflows, coordinating with editors, reviewers, and authors, and ensuring publication timelines are met. Additionally, the role involves tasks such as manuscript management, editorial support, administrative task management, and overseeing end-to-end editorial operations for assigned journals. You will be responsible for assigning manuscripts to editors, managing the peer-review process, and maintaining timely communication between authors, reviewers, and editors. Quality control measures such as reviewing manuscripts for quality, plagiarism, and compliance with guidelines will also be part of your duties. Keeping accurate editorial records and databases, supporting editorial board activities, and assisting in onboarding new reviewers/editors are essential aspects of the role. Collaboration with the production team to ensure timely publication is also a key responsibility. The company, RSIS International, is dedicated to promoting the latest academic and scientific research. With a mission statement that evolves with internal changes and global developments, RSIS International aims to serve as an organization that stimulates, guides, and supports its members in fulfilling the general aim of building research and development activities for the advancement of general welfare.,

You are a Quality Review Specialist with 3 to 6 years of experience in healthcare products and revenue cycle management. Your primary responsibility is to ensure the highest quality standards in healthcare solutions. This hybrid role involves night shifts and offers the flexibility to work remotely and on-site without requiring travel. Your tasks include conducting comprehensive quality reviews of healthcare products to ensure compliance with industry standards and regulations. You will collaborate with cross-functional teams to pinpoint areas for product quality and performance enhancements. Analyzing data from revenue cycle management processes to identify trends and improvement opportunities is also part of your role. You will be developing and implementing quality assurance protocols to uphold the integrity of healthcare products. Providing feedback and recommendations to product development teams for improving product quality is essential. Monitoring and reporting on quality metrics to drive continuous improvement in healthcare solutions and ensuring proper documentation and adherence to quality review processes are key responsibilities. Additionally, you will assist in creating training materials to educate staff on quality standards and procedures. Your technical expertise in healthcare products will be utilized for troubleshooting and resolving quality issues. Engaging with stakeholders to communicate quality review findings and action plans, supporting corrective actions, and participating in quality review meetings to track progress and address challenges are crucial aspects of your role. To excel in this position, you should possess strong analytical skills, demonstrate proficiency in revenue cycle management processes and tools, exhibit excellent communication skills, and have a keen eye for detail to identify potential quality issues. Your ability to adapt to a hybrid work environment, maintain a proactive approach to problem-solving and continuous improvement, and show a strong understanding of healthcare industry regulations and standards will be essential for success. Stay updated with the latest industry trends and best practices in quality assurance to contribute effectively to the organization.,

ORGANISATIONAL OVERVIEW Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. JOB DETAILS Acts process owner of all Global studies ETMF and PDMS Quality review of CTM documents Low risk & repetitive EXPERIENCE Fresher EDUCATIONAL QUALIFICATION Fresher - B.Pharm/ M.Sc

Responsibilities & Key Deliverables Build Customer Satisfaction by focusing on Process Adherence : - Review the Pre Sales, Post Sales Reports, Composite Sales Satisfaction Scores and Mystery Audit reports to identify the gaps in Process Adherence - Review the adherence to Sales Story and Test Drives. - Review the adherence of Process Circulars and Guidelines - Conduct Root Cause Analysis/ANALYSE CUSTOMER VOICE to identify the factors impacting Customer Satisfaction - Validate the Composite Action Plan for Dealerships to ensure Process Adherence in partnership with ASM - Update the Dealerships and ASMs on changes in the Process and address doubts - Digitization - With the beginning of Digitization, several processes will get impacted. The MFFT will play a key role in integrating these changes in the Dealership. - Share any key insights from reports such as TB, Presales, and Composite Sales Satisfaction Scores with the respective Dealership and ASM - Coach the SSI Champion, Delivery In - charge & Home Installation Executive on the various Sales Related Process Parameters. - Concern Management/monitor & control in reducing concerns SSI events - Review of low performing dealers in terms of composite scores, proprietary scores, JDP syndicate scores & crusade R&R competition benchmarking for continuous process improvement activities CSAT improvement commercial vehicles. 2. Develop Dealer Manpower: - Identification of Training & Development Needs for the Dealership Manpower (Both Functional and Leadership - Create the Training Calendar for the month by evaluating needs from the MILE Portal, Dealership Requirements and Area Office Inputs. - Create the plan for the Retainer Trainer to cover the Trainings as per the Calendar. - Review the coverage on a monthly basis. The plan should adhere to the Accepted Budgets - Guide the Retainer Trainer on the Training Calendar for the month. Review Utilization of Retainer Trainer on a regular basis. - Evaluate the Retainer trainer based on the feedback from stakeholders (trainees, Drona, Dealer HR, Dealer Leadership) - Certify Manpower as per the Criteria to determine Manpower Quality. Evaluate Manpower on the Job to determine Manpower Quality - Review the Retainer on the Various Performance Parameters - Accountable for enhancing the productivity of the Key Manpower and Dealer HR. 3. Engage and Retain Dealer Manpower: - Manpower Adequacy: Review the Dealership HR on Manpower Adequacy and Quality and the HR practices at the Dealership. - Engage Dealer Manpower: Review the Dealership on the quality of HR Practices. Coach the Dealer HR on effective HR activities, employee engagement initiatives, Reward & Recognition practices and building a Culture of Agility & Responsiveness, Vibrancy and Passion. - Rollout of the Employee Satisfaction Survey at the Dealership and identification of root causes impacting the Dealership. Accountable for the Action Plan for the Dealership. - Discuss any key employee issues with the Dealership Leadership and provide ideas on possible solutions. Create Manpower Dashboards and share with the Respective Regional Manager and Dealer Principals. Preferred Industries Automotive Industry Education Qualification Any Graduate or BE or MBA , Preferred General Experience 5+ of Experience

Summary: Technical expert with depth or breadth of knowledge within Quality Review and Audit. Applies standard techniques and procedures to routine instructions but requiring professional knowledge in specialist areas. Provides standard professional advice and creates initial reports/analyses for review. Develops and distributes audit reports. Assists with third party audits by completing questionnaires, validating selected claims, responding to errors, etc. Identifies and recommends changes to improvements in department processing and procedures and assists in the development of audit guidelines. May develop and/or recommend training programs to address error trends. Provides guidance, coaching, and direction to more junior team members of the team. Acts independently working under limited supervision. Job Location: Bengaluru, India (Work from office) Work Shift: US Shift - 17:00 to 02:00 IST Responsibilities: Completes audits to ensure claim advocates understanding of current Cigna policies and procedures, including job aids, Articles, and alerts. This includes claim processing guidelines, regulatory requirements, contractual benefits, and specific customer circumstances. Understanding of the appropriate application of claim and other directional documents/tools is a key component of the quality assurance auditing process. Interfaces with matrix partners in relation to quality audit process, specifically address gaps identified through audit process and recommendations for gap closure. Completes review of documents related to audits to help ensure direction is clear and consistent with processing of work. Provides feedback to operations where updates may be required to drive consistency and accuracy. Completes inter-rater reliability exercises with peers, other quality roles and business owners to provide insight into review process. Understanding of the appropriate standard operating procedures and other directional documents/tools is a key component of the quality assurance auditing process. Provides a quality review voice in various workgroups pertaining to workflows, documentation and issues driving errors, in an attempt to continuously improve results. Supports, educates, and reinforces the workflows, processes, tools for the nurses. Provides support for internal and GSP sites based on business needs. Support Coaching and Training program and responsibilities when needed to Support for Business needs and requirements which could include answering Q&A, facilitate trainings, and Coaching s. Qualifications: Overall 5+ years of experience in Healthcare Claim Adjudication process (in that min 1.5 years of auditing experience). US & International claims experience preferred. At least 1+ year Diamond claim processing experience required. Customer Service Driven; ability to meet and exceed the internal partner and external customer expectations. Proven outcomes in critical thinking and decision-making outcomes. Proven outcomes in problem solving skills; utilization of technical skills and resources to ensure accuracy of final resolution. Proven process improvement skills: ability to assess trends, processes, and barriers to drive positive outcomes for claim resolutions. Must be comfortable and effective working in a diverse environment; office and/or virtual environment (if any). Strong organization and time management skills; effectively adapts to multiple and/or competing priorities. Strong communication skills, both verbal and written; ability to adapt communication to the individual or audience.

. - Conducting and oversee money laundering related alert data collection, analysis, and retention, via the review of transaction(s) generated by Actimize, manual systems, referred or otherwise, that have been raised within a related workflow, and writing a quality data analytics summary, at the direction of the Line Manager, or designee. - Under the guidance of the Team Lead, exercise Subject Matter Expertise in the Due Diligence research, relevant to cross-border wire transfers, as it pertains to adverse media, subscription-based intelligence sources, and open-source data sources, while understanding the principles of the Compliance Operations of Mashreqbank New York (MBNY), as well as with operations of correspondent financial institutions, in general. - Manage Analysts, if assigned by the Team Lead. When appropriate, conduct quality review of their work product. When assigned, conduct formal assessment of KPIs and other productivity and quality markers. - Adhere to relevant regulations and guidelines that are issued by the US BSA/AML regulatory authorities (FED and NYSDFS). - Stay abreast with relevant AML guidelines that are issued by non-regulatory agencies such as FATF, Basel, Wolfsburg, etc. - Adhere to the MBNY TM Standard Operating Procedures (TM SOP), as well as with other applicable Bank guidelines / procedures, in support of the Team Lead or designee. - Support MBNY Compliance effort by providing quality research, as required by the MBNY TM SOP or directed by MBNY Compliance Management. - Pro-actively escalate critical issues (compliance / regulatory) to the Team Lead, or other parties, as required by the MBNY TM SOP. - When directed by the Team Lead, conduct secondary reviews of alert Due Diligence research results. - Performs any other relevant duties which may be assigned by the Team Lead, Manager MBNY TM, MBNY Head of Transaction Monitoring, or MBNY MLRO. - Meets all prospective and resulting deliverables of joint ROE exams, MBNY QC, QA, and Internal Audit reviews. - Participate in training sessions, and complete all training assignments, as assigned by the Team Lead, or any other authorized Mashreq employee. - Work with Team Lead in identifying research process efficiencies. - Strive to be prepared to perform the function of the Team Lead in their absence. Show more Show less

Core Responsibilities: 1. Regular monitoring of the real estate portfolio by conducting periodic asset quality review through project site visits , data analysis , meetings, etc 2. Ensuring post disbursal compliance as per the sanction terms including, security perfection and appropriate charge creation along with filling in ROC (Registrar of Companies), disbursement milestones etc for the assets securing the facility 3.Identifying early warning signals 4.Preparing of Asset quality review notes for allotted region in timely manner. The AQR notes are extensive and needs to be made by the candidate, covering exposure movements, compliances, RERA , projections vs actual variances etc and highlighting variances and recommending corrective actions and presentation as per DoA (Delegation of Authority) 5.Liaisoning with Audit Firms , Legal and Technical vendors for getting reports on timely manner 6.Participating in preparation of facility documents for disbursements 7.Follow up for Post Disbursal documents (PDD) , MIS preparation and publication 8.Working on SICR (significance in credit risk) reporting to NHB. 9.Handling internal and externals Audits - requirements. 10.Process mapping and Process Improvement related to the business. 11.NOC management and issuance 12.Escrow account management.

As a member of Pfizer's quality assurance team, you will play a crucial role in ensuring the delivery of safe and effective products to patients. Your commitment to quality, compliance, and patient-centric approach will directly impact the lives of those who rely on our products. Your responsibilities will include evaluating and reviewing clinical and commercial drug batches to ensure they meet established specifications. You will conduct rigorous sampling and statistical process control procedures to identify deviations from standards and approve investigations and change control activities to maintain compliance with configuration management policies. In this role, you will contribute to moderately complex projects by managing your time effectively and developing short-term work plans. Your ability to independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts will be crucial in maintaining regulatory compliance. Your preferred educational background should include a degree in B.Pharm/ M.Pharm/M.S (Pharmacy)/M.Sc/ BE and 5-10 years of experience in the validation function of a sterile injectable dosage form facility. Your core competencies should include familiarity with the design and working principles of key equipment used in sterile manufacturing, knowledge of pharmaceutical manufacturing, packaging, quality assurance, and quality control operations, and expertise in validation principles and practices related to various areas. You should be well-versed in Terminal process design, execution, and review, as well as experienced in plant and TS operations. Your document review skills, data analysis capabilities, and knowledge of validation instruments and tools will be essential in this role. You should also have a good understanding of current validation regulations, cGMPs, FDA regulatory guidelines, and other industry standards. Your technical skills, leadership abilities, organizational planning, and project management capabilities will be put to the test as you coordinate multi-disciplinary teams and ensure compliance with global regulatory and Pfizer quality standards. Strong interpersonal and communication skills are also required to interface across departments and management levels effectively. If you are looking to use your expertise for a purpose-driven role, Pfizer is an equal opportunity employer that values diversity and compliance with all applicable equal employment opportunity legislation. Your work location will be on-premise, where you will have the opportunity to make a meaningful impact on patient outcomes through your commitment to quality assurance and control.,

As a Customer Service Specialist at Accenture, you will leverage your 7 to 11 years of experience in the US Retirement Services domain, specifically Defined Contributions. Your role will involve managing processes related to Money In, Money Out, or Institutional contributions with a team of 20-30 resources. You will be responsible for overseeing remote transition, handling process reporting metrics such as SLA, TAT, Quality, AHT, NIGO, RCA, and identifying areas for improvement. Your leadership skills will be crucial as you manage and lead a team of operations professionals, assigning work, monitoring progress, providing feedback, coaching, and evaluating performance. Quality review of high dollar Money In Retirement Services Transactions and ensuring compliance with company policies and regulations will also be part of your responsibilities. In addition, you will play a key role in managing customer relations, resolving queries, preparing operational performance reports, and collaborating with other departments for effective integration. Your Bachelor's degree and experience in Retirement Services will be valuable in successfully overseeing operations and leading teams. To excel in this role, you must possess strong leadership skills to motivate and inspire team members, excellent communication skills for presenting complex information, and analytical problem-solving abilities to identify and address operational issues. Your knowledge of operational best practices, including quality control, performance management, and process improvement, will be essential for driving operational excellence. Proficiency in MS Office applications such as Word, Excel, and PowerPoint, along with strong organizational skills to manage multiple projects simultaneously, will be required. Your ability to work both independently and collaboratively within a team environment will contribute to your success in this role.,

You will be leading and coaching a team of 8-10 valuation professionals working across single or multiple offices/geographies. Your primary responsibility will involve overseeing the end-to-end preparation of valuations for illiquid investments, specifically focusing on equity and debt valuation within the portfolio valuations space. In this role, you will be required to manage workflow, staffing, quality review, project timelines, and team utilization to ensure the high-quality and timely delivery of projects by yourself and your team members. Additionally, you will provide support in reviewing and executing complex valuation projects, guiding the team on relevant accounting standards, as well as addressing issue-based or project-specific topics. Your contributions will extend to executing the growth strategy of the team(s), identifying markets and products to target, and establishing the necessary skill sets and structures to support growth and scalability. You will also play a key role in enhancing integration with onshore teams, driving business generation from existing and new onshore teams, and maintaining strong connections to achieve positive business outcomes for the KGS team(s). Furthermore, you will be responsible for recruitment, learning and development, and performance management within the team(s). As a part of your role, you will lead at least one CF team-level task force and contribute to pan-DA initiatives. Qualifications: - Educational qualifications required for this position include CA/CFA/MBA with a specialization in Finance & Investment Management. - The ideal candidate should have a minimum of 8 years of working experience in a portfolio valuations role.,

Summary Technical expert with depth or breadth of knowledge within Quality Review and Audit. Applies standard techniques and procedures to routine instructions but requiring professional knowledge in specialist areas. Provides standard professional advice and creates initial reports/analyses for review. Develops and distributes audit reports. Assists with third party audits by completing questionnaires, validating selected claims, responding to errors, etc. Identifies and recommends changes to improvements in department processing and procedures and assists in the development of audit guidelines. May develop and/or recommend training programs to address error trends. Provides guidance, coaching, and direction to more junior team members of the team. Acts independently working under limited supervision. Job Location: Bengaluru, India (Work from office) Work Shift US Shift - 17:00 to 02:00 IST Responsibilities Completes audits to ensure claim advocates understanding of current Cigna policies and procedures, including job aids, Articles, and alerts. This includes claim processing guidelines, regulatory requirements, contractual benefits, and specific customer circumstances. Understanding of the appropriate application of claim and other directional documents/tools is a key component of the quality assurance auditing process. Interfaces with matrix partners in relation to quality audit process, specifically address gaps identified through audit process and recommendations for gap closure. Completes review of documents related to audits to help ensure direction is clear and consistent with processing of work. Provides feedback to operations where updates may be required to drive consistency and accuracy. Completes inter-rater reliability exercises with peers, other quality roles and business owners to provide insight into review process. Understanding of the appropriate standard operating procedures and other directional documents/tools is a key component of the quality assurance auditing process. Provides a quality review voice in various workgroups pertaining to workflows, documentation and issues driving errors, in an attempt to continuously improve results. Supports, educates, and reinforces the workflows, processes, tools for the nurses. Provides support for internal and GSP sites based on business needs. Support Coaching and Training program and responsibilities when needed to Support for Business needs and requirements which could include answering Q&A, facilitate trainings, and Coachings. Qualifications Overall 5+ years of experience in Healthcare Claim Adjudication process (in that min 1.5 years of auditing experience). US & International claims experience preferred. At least 1+ year Diamond claim processing experience required. Customer Service Driven; ability to meet and exceed the internal partner and external customer expectations. Proven outcomes in critical thinking and decision-making outcomes. Proven outcomes in problem solving skills; utilization of technical skills and resources to ensure accuracy of final resolution. Proven process improvement skills: ability to assess trends, processes, and barriers to drive positive outcomes for claim resolutions. Must be comfortable and effective working in a diverse environment; office and/or virtual environment (if any). Strong organization and time management skills; effectively adapts to multiple and/or competing priorities. Strong communication skills, both verbal and written; ability to adapt communication to the individual or audience. About The Cigna Group Cigna Healthcare, a division of The Cigna Group, is an advocate for better health through every stage of life. We guide our customers through the health care system, empowering them with the information and insight they need to make the best choices for improving their health and vitality. Join us in driving growth and improving lives. Show more Show less