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2.0 - 5.0 years
3 - 6 Lacs
Bengaluru
Work from Office
Job Summary: We are seeking a meticulous and detail-oriented Quality Checker to join our packaging artwork team. The role requires thorough experience in reviewing packaging artworks for compliance, consistency, and accuracy. The ideal candidate should be familiar with Adobe Creative Suite tools and artwork validation workflows in regulated industries like pharmaceutical or CPG/FMCG domains. Role & responsibilities Verify packaging artwork files against technical briefs, regulatory standards, and brand guidelines. Check alignment, font consistency, spelling, and layout accuracy in Illustrator and InDesign files. Compare artwork revisions using visual comparison tools or side-by-side manual methods. Validate correct Pantone, CMYK, and black/white color usages as per print specifications. Ensure images and logos are high-resolution, color corrected, and placed correctly. Track version history and ensure all changes are properly implemented and approved. Collaborate with designers, regulatory, and project managers to resolve discrepancies or errors. Support final quality checks before prepress or print delivery. Document QA feedback, maintain checklists, and prepare reports on defects or non-conformities. Support towards RCA/CAPA Preferred candidate profile 3+ years of experience in packaging artwork QA or Quality control with process improvement suggested based on the errors identified against Designers/Artworkers Strong knowledge of Adobe Illustrator, InDesign, and Acrobat for visual checks (Mandatory) Familiarity with color formats (Pantone, CMYK, RGB) and prepress compliance Ability to detect layout errors, font mismatches, bleed/trims, and inconsistencies Good communication skills for documenting and escalating issues Understanding of regulatory packaging standards (especially in Pharma or CPG/FMCG) Proficiency in using markup tools, comparison software
Posted 5 days ago
3.0 - 5.0 years
3 - 6 Lacs
Bengaluru
Work from Office
Role & responsibilities Above site review as part of GIT Completes above site level real time review, assessment and scoring of all aspects of Investigations including Deviations, LIRs, Complaints, CAPAs, using preapproved standard rubrics to ensure scientific rigor and discipline is applied to identify root cause for Investigations including proposal of effective CAPAs, prior to investigation closure. Submits the draft investigation report and completed rubric to the GIT on a timely basis to permit their review and feedback within the due date. Implement/reinforce Investigator and Approver Certification (IAC) rubrics / evaluation-based education and coaching for site Quality decisions on investigations and CAPA, drive continuous improvement and standardization across the organization. Ensures that investigations identify the true root cause based on Scientific rigor, Human Error causes are properly investigated, Impact and Risk level are appropriately assessed, and the corrective and preventative actions are commensurate. Ensures all comments from GIT are addressed in the final report and gets final approval from GIT before closure of investigation. Ensures that review of assigned number of investigation reports is completed as per required Works as a member of the Global Investigation Team (GIT) network to achieve a sustainable self-teaching model, to spread good investigation practices and to share learnings and best practices to Site/Function through the multiple established Forums at the sites. Acts as resource providing support and guidance to SIT, QA Approvers and Lead Investigators at the site Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance, and Passion; Demonstrate strong and visible support of our values. Performs all work in compliance with our Code of Conduct and Business Ethics, related policies and with the legal and regulatory requirements that apply to our job activities. Preferred candidate profile Education Bachelor's degree in science or a related Level 2 Certification: Investigation and CAPA Expert Knowledge, Skills and Abilities Strong knowledge and application of cGMPs/GMPs in a pharmaceutical manufacturing and in QA/QC environment Deep understanding of Investigation process and CAPA management Demonstrated ability to work independently and effectively manage multiple priorities in a fast paced and changing environment. Excellent interpersonal, communication, presentation, and facilitation Critical thinking and application of scientific reasoning Demonstrated ability to work in partnership with and build strong links to all areas of the business. Ability to provide effective feedback and coaching to others. Experience Minimum of 5 years of regulatory compliance and quality experience in the pharmaceutical or related industry with experience in quality, production or laboratory systems Minimum 3 years of practical experience in Investigations management.
Posted 1 week ago
10.0 - 15.0 years
17 - 18 Lacs
Hyderabad
Work from Office
Work Mode: On-site (Work from Office) Key Responsibilities • Conduct independent quality reviews of Individual Case Safety Reports (ICSRs) with a strong understanding of the end-to-end ICSR process • Oversee the quality review of aggregate safety reports (preferred but not mandatory) • Develop and maintain the lifecycle of Standard Operating Procedures (SOPs) • Manage the change control system and handle deviations or non-conformances, including investigations, root cause analysis, implementation of corrective and preventive actions, and monitoring of effectiveness • Identify and implement process improvements and best practices in PV quality assurance methodologies • Maintain and update training matrices and ensure delivery of relevant and timely training programs • Prepare for audits and inspections by coordinating data requests and communication with internal teams and external authorities • Address audit findings and implement corrective and preventive actions as required • Monitor compliance and risk across multiple projects at defined intervals • Conduct regular quality review meetings and ensure documentation and follow-up on action points Desired Skills & Attributes: • Good understanding of PV quality systems, compliance processes, and regulatory expectations • Ability to independently manage quality review activities and provide constructive feedback • Strong problem-solving skills with a practical approach to handling deviations and driving improvements • Good communication skills with experience in coordinating across multiple teams • Comfortable working in a fast-paced environment with shifting priorities Preferred Background : Experience in pharmacovigilance quality assurance with exposure to both pharmaceutical companies and service-based organizations Prior experience in pharmacovigilance operations is an advantage. Educational Qualifications : Bachelors or masters degree in pharmacy or a related field. Experience :10 to 15 years of relevant experience in pharmacovigilance quality assurance Previous experience in leading or mentoring teams is preferred
Posted 3 weeks ago
0.0 years
2 - 5 Lacs
Noida, Greater Noida, Delhi / NCR
Work from Office
Job Description: US Mortgage Location: Noida Shift Timings: Flexible (Rotational Shifts) About the Role: NLB Services is Looking forward to hiring underwriters who have experience in the US Mortgage industry or Quality review experience . Experience:- 1 to 4 years Job Location: Noida (Work from Office) Shift:- 5.30 PM to 2.30 AM Immediate joiners are preferred. Both Sides Cabs Available Skills - Loan Servicing , Loan Processing , underwriter , US Mortgage, Quality review check ,Quality review
Posted 3 weeks ago
2.0 - 6.0 years
3 - 8 Lacs
Mumbai
Work from Office
RESPONSIBILITIES Book-in, Data Entry and Quality Reviewer of ICSR in Argus database ICSR Global Submission (Timelines and Submission Process) Vendor Management SOP training in department as and when needed DESIRED SKILLS Good knowledge about GVP (Good Pharmacovigilance Practices) modules and guidelines. Good knowledge about timelines and submission process of Global ICSRs w.r.t to multiple health authorities. Good knowledge about Global submission mailbox, maintenance of submission data and trackers of all ICSR submission activities including correspondence with regulatory authorities and submission records for audits and inspection readiness. Basic knowledge of Computers Good Communication skills
Posted 3 weeks ago
0.0 years
2 - 5 Lacs
Noida, Greater Noida, Delhi / NCR
Work from Office
Job Description: Fresher - Banking and Financial Services Location: Noida Shift Timings: Flexible (Rotational Shifts) About the Role: We are seeking motivated and adaptable freshers to join our team in the Banking and Financial Services sector. This is an excellent opportunity for individuals looking to start their careers in a dynamic industry, with multiple process roles available, including research, remediation, keying, and data entry.
Posted 3 weeks ago
3.0 - 8.0 years
6 - 16 Lacs
Hyderabad
Work from Office
Role & responsibilities : Perform comprehensive inpatient DRG validation reviews to determine accuracy of the DRG billed, based on industry standard coding guidelines and the clinical evidence supplied by the provider in the form of medical records such as physician notes, lab tests, images (x-rays etc.), and with due consideration to any applicable medical policies, medical best practice, etc. Based on the evidence presented in the medical records, determine, and record the appropriate (revised) Diagnosis Codes, Procedure Codes and Discharge Status Code applicable to the claim. Using the revised codes, regroup the claim using provided software to determine the new DRG Where the regrouped ‘new DRG’ differs from what was originally claimed by the provider, write a customer facing ‘rationale’ or ‘findings’ statement, highlighting the problems found and justifying the revised choices of new codes and DRG, based on the clinical evidence obtained during the review Document all aspect of audits including uploading all provider communications, clinical rationale, and/or financial research Identify new DRG coding concepts to expand the DRG product. Manage assigned claims and claim report, adhering to client turnaround time, and department Standard Operating Procedures Meet and/or exceed all internal and department productivity and quality standards Recommend new methods to improve departmental procedures Achieve and maintain personal production and savings quota Preferred candidate profile : Registered Nurse licensure preferred Graduate Inpatient Coding Certification required (i.e., CCS, CIC, RHIA, RHIT) 3 – 5 years reviewing and/or auditing ICD-10 CM, MS-DRG and APR-DRG claims preferred Solid understanding of audit techniques, identification of revenue opportunities and financial negotiation with providers Experience and working knowledge of Health Insurance, Medicare guidelines and various healthcare programs Understanding of hospital coding and billing rules Clinical skills to evaluate appropriate Medical Record Coding Experience conducting root cause analysis and identifying solutions Strong organization skills with attention to detail Outstanding verbal and written communication skills
Posted 3 weeks ago
0.0 - 5.0 years
1 - 3 Lacs
Mumbai, Navi Mumbai, Mumbai (All Areas)
Work from Office
To Apply: Send your updated CV to Karishmap@itm.edu or call Karishma at 8433973130 Location: Navi Mumbai Organization: ITM Group of Institutions Website: www.itm.edu What Were Looking For: A recent graduate with a strong eye for detail and logical thinking. Fluent in English , with excellent documentation and communication skills. Comfortable using digital platforms, websites , and online tools. A quick learner , able to spot inconsistencies and work methodically. Sincere, proactive, and eager to get things right the first time. About the Role: We are looking for a sharp and attentive fresher to join our dynamic Digital Content Team as a Quality Analyst . This is a non-content creation role focused on quality-checking websites, digital campaigns, WhatsApp bots, and more. If you're detail-oriented , passionate about flawless digital experiences, and eager to learn the ropes of digital operations this role is the perfect launchpad for your career in digital marketing and technology. Key Responsibilities: Perform quality checks across websites, landing pages, and digital campaigns. Test forms, CTAs, links, and user interactions across platforms. Identify and report design/content inconsistencies, broken links, and errors. Coordinate with teams to ensure timely implementation of updates. Follow and enhance standardized checklists for QC processes. Collaborate with designers, developers, and content strategists to ensure consistency in brand experience.
Posted 4 weeks ago
2.0 - 6.0 years
4 - 7 Lacs
Hyderabad
Work from Office
Quality Assurance Role Purpose The purpose of this role is to conduct audits to ensure quality compliance within the account. Requirement Provide Clear and crisp understanding of error made by the reviewer : Freshers or 6 months experience in any Quality Review process Good working knowledge of computer i.e., MS-Office (Google sheets will be an added Advantage) Good client management skills with eye for detailing, proactively identifying gaps in processes and flag it to internal leadership & client as appropriate Good Interpersonal & people management skills with good problem solving approach Ability to exercise managerial judgment and perform as a mentor. Ability to multi task multiple activities by effective delegation and monitoring Ability to work well under pressure Client oriented, flexible, patient Excellent English written communication skills Good organizational skills For Experience candidates Excellent verbal & written communication & presentation skills Good client management skills with eye for detailing, proactively identifying gaps in processes and flag it to internal leadership & client as appropriate Good Interpersonal & people management skills with good problem solving approach Good analytical skills for MIS, number crunching & reporting to internal & external customers Ability to exercise managerial judgment and perform as a mentor. Ability to multi task multiple activities by effective delegation and monitoring Demonstrated Customer Service Skills Mandatory Skills: QAAS(Advisory Services).
Posted 1 month ago
2.0 - 7.0 years
3 - 8 Lacs
Mumbai
Work from Office
At American Journal Experts (AJE, powered by MPS), we help researchers successfully communicate their work through trusted author-oriented solutions to overcome the barriers to the manuscript preparation process. We are actively recruiting Quality Control Inspectors (QCIs) with field-specific expertise. QCIs execute and advise on quality control strategies by monitoring English language quality in academic manuscripts to ensure that our output and systems are achieving AJE standards. They monitor and provide feedback on contractor quality and exercise judgment on contractor adherence to AJE quality standards. QCIs utilize the latest technology supplied by AJE to support high-efficiency, target-quality edits. QCIs support a dynamic and evolving part of AJE operations. This job is on-site in Mumbai, India. This is not a remote position. What QCIs deliver: Above-and-beyond service to meet our customers needs Timely completion of QC edits to ensure quick return to customers QC edits that meet internal quality standards and product specifications Clear communication with managers and process stakeholders How to apply: To know more about the job description kindly share us your Resume/CV at https://americanjournalexpertsaje.applytojob.com/apply/SFpPyMVT4t/Language-Editing-Quality-Control-Inspector-Mumbai
Posted 1 month ago
4.0 - 8.0 years
3 - 7 Lacs
Akola
Work from Office
Role & responsibilities Responsible for following activities: a. Verify cGMP, GDP, GLP and data integrity practices, compliance in Quality Control and microbiology laboratory. b. Review of Specification, Standard test procedures and test data sheet for adequacy and accuracy. c. Review Validation and calibrations of all Instruments. d. Review of AMV, AMT Protocols and reports. e. Handling of Lab incidents, Deviations, OOS, OOC, OOT etc. f. Handling of reserved sample of finished products and its visual inspection. g. Review of trend data of environmental monitoring, water analysis. h. Participation in audit the contract testing laboratory. Preferred candidate profile ERP/ QMS/QC software system handling experience
Posted 1 month ago
7.0 - 12.0 years
4 - 9 Lacs
Ahmedabad
Work from Office
Role & responsibilities Lead, mentor, and manage the Pharmacovigilance QA team to ensure effective execution of QA activities. Develop, implement, and maintain QA processes, procedures, and tools aligned with regulatory guidelines (e.g., ICH, FDA, EMA). Monitor and ensure compliance of pharmacovigilance activities with applicable regulations and internal SOPs. Conduct risk assessments and develop mitigation plans to ensure PV compliance . Oversee the management and closure of CAPAs (Corrective and Preventive Actions) following audits or inspections. Plan, coordinate, and conduct internal and external audits of PV processes, systems, and vendors audits ( Risk Based Audit approach ). Lead audit preparedness activities and ensure timely resolution of audit findings. Collaborate with cross-functional teams to implement audit recommendations and continuous improvements. Maintain audit documentation and track audit metrics for management review. Ensure all QA activities support compliance with global pharmacovigilance regulations, including GVP (Good Pharmacovigilance Practices). Participate in regulatory inspections and provide QA support as needed. Review and approve quality documentation related to PV activities such as SOPs, training materials, and audit reports. Identify QA training needs for the PV team and develop training programs accordingly. Conduct and coordinate training sessions on quality standards, SOPs, and compliance requirements. Promote a quality culture and awareness within the PV department. Identify gaps and areas for improvement within PV and QA processes and implement best practices. Collaborate with PV operations and other departments to optimize workflows and enhance quality outcomes. Utilize metrics and KPIs to monitor quality performance and drive continuous improvement. Act as the key liaison between PV, QA, regulatory affairs, and other stakeholders. Provide guidance and support on quality-related matters to internal teams and external vendors. Facilitate effective communication to ensure alignment on quality expectations and deliverables. Plan, assign, and review work for QA team members and provide ongoing feedback and development opportunities. Facilitate team meetings and promote continuous communication and knowledge sharing within the team. Support recruitment, onboarding, and performance management of QA staff. Preferred candidate profile Bachelors degree in Pharmacy, Life Sciences, or related field (Master’s preferred). Extensive experience (typically 7+ years) in Pharmacovigilance with significant exposure to QA activities. Strong knowledge of global pharmacovigilance regulations, GVP, and quality management systems. Proven leadership and team management skills. Experience in conducting audits and managing CAPAs . Excellent communication, organizational, and problem-solving skills. Ability to work collaboratively with cross-functional teams and external vendors.
Posted 1 month ago
2.0 - 4.0 years
2 - 4 Lacs
Vadodara
Work from Office
Experience: 2-4year experience in the clinical research in a quality control. Role & responsibilities 1) Review of clinical raw data as per predefined Quality Control Plan for completeness, accuracy, and for compliance with the Study Protocol, GCP, SOPs and applicable regulatory Guidelines. 2) Online Monitoring of study activities to ensure that studies are conducted in accordance with GCP, SOPs, Protocol and applicable regulatory guidelines. 3) Issuance, Reconciliation and Accountability of Controlled forms/ Documents as per applicable SOP. 4) Preparation of projects for QA audit and Archiving. 5) Review of Tabular listing appended to Clinical Study Report and Individual Subject CRF scan check (as applicable). 6) Assist QC in-charge in review of Quality Control- Clinic SOPs. 7) Any additional responsibility given by Head of the Department / Management 8) Perform source data verification (SDV) activity (as sponsor requirement) 9) Review the safety Lab data (as per Data Transfer Agreement) Job Location: Vadodara (Gujarat)
Posted 1 month ago
2.0 - 5.0 years
2 - 6 Lacs
Hyderabad
Work from Office
Roles and Responsibilities Conduct quality reviews of documents, including CAPAs, change controls, and 21 CFR compliance. Ensure adherence to company policies and procedures through document review. Develop and maintain a thorough understanding of regulatory requirements for pharmaceuticals. Provide feedback on document quality and suggest improvements where necessary. Collaborate with cross-functional teams to resolve issues related to document control.
Posted 1 month ago
7.0 - 11.0 years
4 - 8 Lacs
Bengaluru
Work from Office
Skill required: Pharmacovigilance Services - Safety Writing Designation: Pharmacovigilance Services Specialist Qualifications: Bachelor of Pharmacy Years of Experience: 7 to 11 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 Prepare and review PSUR/ PBRER/DSUR/PADER/ Addendum Statement/Addendum to clinical overview/US IND reports/ Aggregate finding safety reports/Local reports/ Cumulative Review/Health Authority requests / Health Authority assessment reports as per the applicable procedural documents on the project.Perform scheduling of reports, and author, peer review, publishing, tracking and management activities of assigned reports.Perform request for inputs activity for the reports (based on the RFI [request for information] and as per the applicable process and SOPs).Send the case closure request and request for Line Listings/ Summary Tabulations, as applicable.Initiate, organize, and lead the strategy meeting for evaluation of safety topic/request. Prepare meeting minutes and distribute final minutes with all invitees.Review the information received from contributors and obtain any missing information.Draft aggregate report using clients templates including analysis of safety, clinical and other global line function data. Summarize literature information for applicable reports.Perform peer review of the draft report.Share the draft for quality review.Address the comments from the peer reviewer, quality reviewer and incorporated into the report.Share the draft report with client (or external) stakeholders for review (as applicable).Incorporate and address the comments from stakeholders into the draft report and seek clarification where applicable.Schedule meetings with project safety physicians to resolve report related queries and prepare submission ready draft report.Perform final peer review of draft reports and provide feedback with the duly filled defect tracker.Share the final draft along with the QC scorecard results to client (as applicable).Obtain Client/ESP signature/approvals for the finalized report.Complete and finalize report according to the procedural document requirements.Ensure compliance of finalized report with applicable process and SOPs.Obtain signature/approval for the finalized reports as defined in procedural document What are we looking for Ability to establish strong client relationship Roles and Responsibilities: Prepare/compile the final report and confirm that document is complete, including it contains all the applicable annexes as needed and instructed by client, and then submit the finalized report to client.Notify client (regulatory team) that the final report has been submitted to client and confirm all prepared submission documents are uploaded into client environment.Archive AR-related information in dedicated folders on client shared drives or other electronic repositories (as agreed in the procedural document).Perform HA submission tracking of applicable Aggregate ReportsCapture quality data for metrics reporting.Responsible for knowledge sharing, coaching, review and providing feedback of reports processed by the Mentees.Complete all trainings assigned by internal and client on their LMS within due date.Notify critical and major deviations (referred as Quality Issues) within one business days and minor deviations- three business days to Accenture Quality Management team.Organize, action, and archive the communication received at and sent from AR mailbox appropriately.Share/forward product/document type relevant emails to the appropriate user/owner as required and ensure closure.Management of Accenture personal assigned to the AR function.Oversight on the AR mailbox managementEnsure teams delivery of reports within agreed timelines with SLAs and KPIs.Liaising with client or any issue mitigation and troubleshooting.Ensure the retention.Ensure training and mentoring of new associates and documentation of the same.Address any quality related issues and implementation of quality improvement initiatives for the team. Qualification Bachelor of Pharmacy
Posted 1 month ago
3.0 - 8.0 years
4 - 8 Lacs
Bengaluru
Work from Office
Our vision for the future is based on the idea that transforming financial lives starts by giving our people the freedom to transform their own. We have a flexible work environment, and fluid career paths. We not only encourage but celebrate internal mobility. We also recognize the importance of purpose, well-being, and work-life balance. Within Empower and our communities, we work hard to create a welcoming and inclusive environment, and our associates dedicate thousands of hours to volunteering for causes that matter most to them. Chart your own path and grow your career while helping more customers achieve financial freedom. Empower Yourself. The Tax Reconciler (Sr Spec) has the responsibility for administration supporting both day-to-day processing and reporting of tax forms, and preliminary reconciliation of tax liability. Processing and reporting include updates to tax forms, as well as the review and resolution of form error reporting. Main job is to provide support in : Daily Suspense reconciliation is the act of reconciling the net income on the in the system to the income reported on the tax return by adding and subtracting the non-tax items. QC of both US and Global teams for limited tasks. Trend tracking and reporting Compare audits and reporting. (Missing distribution report will apply here) Ad hoc requests for updates or research as needed Tax form rejects and audit processing require critical thinking, review ESSENTIAL FUNCTIONS: List specific action statements to describe the fundamental responsibilities that encompass the majority of the job (typically those that comprise 10% or more of time). List in order of impact to the company which may or may not be the same as the amount of time required to complete the listed responsibility. Responsible for complex tax form processing and quality review; tax form types include but not are limited to: 1099 R, 1099 MISC, 1099 NEC, and W-2 Performs review of assigned tax reports Completes periodic reports documenting variance root cause and resolution. Verifies problem resolution is timely and accurate. Follows up with appropriate areas regarding unresolved issues. Complete all daily, monthly, and ad-hoc tasks and report accurately Prepare weekly / Monthly reports Provide feedback to improve processes Build expertise to be able to respond to questions from team and serve as team SME Escalate all issues promptly and effectively to Lead/ Supervisor May assist in annual tax form production tasks Other duties as assigned Shift Timing: Variable as per the business demand – Monday to Friday QUALIFICATIONS: Indicate qualifications that are required, if preferred, indicate preferred. Include advanced education or certifications, and/or specific skills, knowledge, experience, or characteristics. Education Qualification: Bachelor’s degree in finance is strongly preferred or equivalent to industry experience Experience: 2.5 -3.5 years financial operations in Reconciliations, Federal tax knowledge. Knowledge and understanding of taxes as they apply to retirement plans Skills required for this Role: Critical Thinking Ability to research independently Basic understanding of 401k and Tax form and Ability to work independently without set steps High level knowledge of MS Excel and able to convert the data into reporting for various management checks. Knowledge of Taxport and Alteryx. Addition Non-Technical Skills for Sr spec Strong analytical/problem solving, written and verbal communication skills Ability to multi-task, prioritize, and problem-solve effectively Strong attention to detail Excellent time management Flexible in shifts Ownership mindset We are an equal opportunity employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to age, race, color, national origin, ancestry, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, religion, physical or mental disability, military or veteran status, genetic information, or any other status protected by applicable state or local law.
Posted 1 month ago
4.0 - 6.0 years
8 - 10 Lacs
Bengaluru
Hybrid
• Develop and review content for various regulatory documents; ensure quality as per setegulatory standards and compliance requirement. • Good understanding of global regulatory dossier formats and ACTD/CTD/NeeS/paper dossier format. • Candidate will need to author and/or review clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD for submission to the Health Authorities in EU and APAC markets, respectively. Key requirement: • Good medical/pharma/scientific knowledge that can be applied in developing content for regulatory documents • Experienced in the development and review of clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD, for submission to the regulatory authority in EU and APAC regions, respectively • Good understanding of clinical trial and product life cycle EDUCATION: MBBS/PhD/MDS/BDS/MPharm/PharmD/BPharm/MSc EXPERIENCE: 4 to 6 years of Regulatory Writing/Reviewing experience LOCATION: Bangalore (Office-based/Hybrid) SKILLS: • Good communication skills (Written and Oral) • MS Office (Excel and Power point) PRINCIPAL RESPONSIBILITIES & ACCOUNTABILITIES: • Broad Area-1: Develop Content to Meet High CSAT Independently (Simple and Complex Projects) o Responsible for developing new drafts/updating existing content/review with quality, accuracy, timelines, and efforts, independently (Protocol, Informed Consent Form [ICF], Investigators Brochure [IB], clinical and non-clinical documents under Modules 2, 4 and 5 of eCTD and, Part III and IV of ACTD) o Responsible to run and review literature searches in various databases and screening articles to obtain required information for content development o Good knowledge of various regulatory guidelines and regulatory dossiers related to regulatory content development o Conduct quality checks to ensure the accuracy and consistency of data included in documents o Build expertise in extracting information from textbooks, authentic websites and articles for different deliverables and therapeutic areas o Demonstrate good technical competence on how to search the internet and books for referencing, copyrights, and plagiarism o Follow the best practices while executing projects in the team with regard to processes, communication (internal and external), documentation and technical requirements like language, grammar, style, content search, summarizing, data conflicts and referencing o Analyze challenges/limitations in content development and provide logical, unbiased, and rational recommendations for modifying quality standards or introducing newer ones o Work with internal stakeholders for project execution and actively participate in team meetings and client meetings from a content perspective • Broad Area-2: Review Content of Team Members o Review the content prepared by junior team members. Validate the authenticity of the content by performing data fact check o Guide team members on content client requirements and quality aspects of content development for different deliverables development (including but not limited to Protocols, IBs, ICF, clinical and non-clinical documents under Modules 2, 4 and 5 of eCTD and, Part III and IV of ACTD), o Guide team members to develop content outlines for different target groups that are accurate, clinically relevant, reflecting the most recent medical advances and in accordance with established content development practices, in collaboration with clients and team leads • Broad area-3: Process Adherence and Compliance o Be aware of all organizational, divisional, and client-related policies and procedures related to quality, information security and data privacy o Responsible to strictly adhere to quality standards for various deliverables as decided by the business unit or client o Responsible to maintain confidentiality and copyright rules for various deliverables/clients and company norms o Follow all the security rules with regard to various standards like ISMS, ISO, CMMI and client guidelines • Broad Area-4: Self-Development o Support in developing technical training programs for other team members relevant to the job o Responsible to complete client-specific training, if applicable o Responsible to build expertise in assigned deliverables through self-learning and formal trainings and stay abreast with current trends in the respective areas o Learn the basic skills to manage teams o Participate in and contribute to various continuous improvement initiatives or company driven initiatives Interested Candidate Please Apply - India.hr@infinitysts.com
Posted 2 months ago
2.0 - 6.0 years
4 - 8 Lacs
Hyderabad
Work from Office
Job title: Team Lead Registry Site Operations Reports to: Group Lead ESR Study & Patient Registry Location: Hyderabad % of travel expected: Travel required as per business need Job type: Permanent and Full time About The Job Our Team: Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally, The Sanofi Business Operations is built to reduce reliance on external service providers and facilitate the development of internal expertise The Sanofi Business Operations (SBO) will leverage an untapped combination of talent pool, Main Responsibilities Team Lead Registry Operations will be responsible for end-to-end project planning & execution with support from 10-15 members, this includes stakeholder engagement, resource planning, and monitoring ongoing work, People: (1) Mentor the registry study/project management team on day to day as well as exceptional cases/ situations in Registry Study project and site management, Study Start-up Activities, Safety & Quality, Study administration, 2) Monitor progress of work and provide solution to issues and queries for above activities;(3) Resource and back-up planning for business continuity;(4) Identify areas for innovation and implement with external and internal partners;(5) Act as key contact and thought partner for contracting related activities;(6) Effective work allocation to the team;(7) Share best practices and serve as a change agent and facilitator for operational excellence, Project: (1) Collaborate with global stakeholders for future projections and setting up the timelines;(2) Ensure that team delivers the ongoing projects as per agreed timelines;(3) Ensure that team follows defined/agreed quality parameters/review before sending out deliverables to the stakeholders;(4)Support team to get resolution on timely basis for technical glitch(es) if any;(5) Closely monitor projects, ensure timely completeness of project tracker, QC of projects, archival of documents in repositories, and maintaining other necessary tracking tools in order to keep trackers and repositories audit readiness, Process: (1) Identify and Propose automation solutions to the stakeholders for registry study/project management process;(2) Collaborate with the stakeholders to simplify above process and provide them with real-time updates and final outputs;(3) Encourage team for new and innovative initiatives;(4) Keep abreast of operational excellence techniques and facilitate constant skill up-gradation of organization employees, Stakeholder: (1) Support global stakeholders for project planning, resource allocation and ensure the business continuity as per agreed plan(s);(2) Help global stakeholders for process improvements, risk mitigation plans, and new initiatives;(3) Maintain effective working relationship with stakeholders and work with them to provide solutions on ongoing issues/problems;(4) Connect with Registry study management governance leaders, internal stake holders for registry study project, site and data management review for status updates About You Experience: 10+ years of experience with global clinical trial management, quality review, stakeholder management, Project management and project tracking and People management Project management certification preferred Strong quantitative, analytical (technical and business) and problem-solving skills is a must Excellent cross-functional collaboration skill and experience required Proven self-starter with experience driving efficiency in processes highly desirable, Soft skills: Excellent written and oral communication skills Excellent organizational and project management skills, and ability to meet deadlines and stakeholder management, Technical skills: Good understanding of the principles of ICH-GCP and applicable local regulatory requirements Familiarity with CTMS is essential for planning, tracking, and managing registries activities Proficiency in EDC systems is crucial for collecting, managing, and analysing registries data Understanding regulations, ICH/GCP guidelines, and other regulatory requirements is vital to ensure compliance throughout the registries Skills in data management, including data cleaning, validation, and statistical analysis, are important for ensuring the integrity and accuracy of registries data Ability to identify, assess, and mitigate risks associated with registries to ensure smooth project execution Take responsibility for self-development to improve performance and positive impact to the organization along with driving individual career progress Embrace change and innovation by supporting the evolution of the Registry study function, driving improved effectiveness Competent with Microsoft Office products, Education: Post Graduate degree in Life science/ Pharma/Medicine with >10 years relevant experience Languages: High Proficiency in written and spoken English Pursue progress, discover extraordinary Better is out there Better medications, better outcomes, better science But progress doesnt happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen So, lets be those people, At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity, Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi ! null
Posted 2 months ago
2.0 - 5.0 years
3 - 4 Lacs
Hyderabad
Work from Office
HCLTech is Hiring || QA Content Moderator || 24th &25th May,2025 || Walk In Drive || 10.00 AM - 3.00 PM || Date: 24th &25th May,2025 Time: 10:00 AM to 3:00 PM Location: Advance Business Hub, An Ascendas IT Park, Building H-01B, Phase 2, HITEC City, Hyderabad, Telangana 500081 Contact Person: Ashish Durgapal Please carry: 2 Updated Resume 1 Passport size 1 ID Proof Pan card/ Aadhar Card (Do not bring any laptops, pen drives, or electronic devices) Designation : Quality Analyst Responsibilities: 1. Review tasks/ transactions on a regular basis - frequency as per business needs. 2. Real-time feedback for moderators, error trend mapping, bottom quartile management and overall agent-level performance improvement. 3. Conduct TNI & as required delivery training refreshers & cascade updates to the team, in coordination the TL or Manager 4. Provide insights to the Managers & Customer in form of daily/weekly reports 5. Keep track of content inflow. 6. Identify gaps/ gray areas in policies & guidelines based on ground truth data. 7. Store, document edge cases, nuanced examples among moderated content to create referenceable repositories. Skills: 1. Experienced in conducting sample audits, gather findings & coach the Analysts 2. Able to identify trends through audit sample data 3. Familiarity with social media and content moderation laws & policies 4. Required to work in night shift hours & weekends 5. Excellent English skills oral and written. 6. Ability to work under pressure and make sound judgment calls; ability to handle egregious content 7. Any graduation degree **Immediate to 45 days notice period candidates are preferred**
Posted 2 months ago
1 - 6 years
0 - 3 Lacs
Pune
Work from Office
Company Profile: Infinity IPS Founded in 2003, Infinity IPS is a mortgage industry leader in providing end-to-end services and solutions. We specialize in mortgage due diligence, pre-fund and post-close quality control, mortgage servicing reviews and loan brokering services. We are vetted by all 5 major rating agencies. Our clients are financial entities including investment banks, commercial banks, mortgage companies, government agencies and mortgage insurers Post Appraisal QC - Analyst/Reviewer - Work from Office Location – Pune Job Shift –Night Shift (7 Pm to 5 Am) – 5 Days Working Vacancies – 10 PERSON WITH EXPERIENCE IN APPRAISAL QC DOMAIN OF US MORTGAGE IS REQUIRED. IMMEDIATE JOINERS TO PEOPLE WITH 15 DAYS NOTICE PREFERRED ONLY ELIGIBLE PEOPLE TO APPLY SHOULD BE READY FOR WORK FROM OFFICE AND NIGHT SHIFT Job Summary: The Appraisal Reviewer is responsible for reviewing real estate appraisals and valuations to ensure accuracy, compliance, and adherence to regulatory guidelines. The role requires a thorough understanding of appraisal standards and forms 1004,1073, 1025, 1004C, 1075 etc. Key responsibilities: Provide high level quality control analysis of completed appraisal reports as needed to meet Client’s expectations. Analyze data and identify discrepancies in appraisal QC reports. Identify the client requirements and work with the appraiser to ensure the report is corrected and returned in an acceptable format. Conduct reviews or analysis of appraisal reports and other valuation products, by approving or declining the reports. This will include Single Family, condos and PUD units, owner occupied or Tenant Should be experience in reviewing Full reports like 1004, 1073, 1025, 2055 exterior,1004C Manufactured home Etc. Checking the accuracy and completeness of the inspection reports which receive from the appraisers, along with other relevant document like purchase contracts, engagement letter, condo questionnaire. Identify potential appraisal deficiencies concerning compliance to AMC guidelines, industry standard guidelines (Fannie Mae, Freddy Mac, FHA), and client specific requirements Ensure that the review process completed accurately and within the required Service level agreement (SLA) timeframes. Tracking and reporting work status to team manager on a regular basis Meet daily targets and goals set by the senior management. Delivery of the final reports with supporting documenting to the client. Ensure all reports meet USPAP and lender requirement Mandatory experience in mortgage industry and knowledge about FHA, VA, USDA, Jumbo, Conventional guidelines. Strong command over written communication.
Posted 2 months ago
1 - 6 years
2 - 6 Lacs
Hyderabad
Work from Office
About The Role Role Purpose As a Quality Assurance Analyst at Wipro Technologies, you will play a crucial role in conducting audits to ensure quality compliance within the account. Your responsibilities will include: Carrying out the detailed assessment of documents that are previously reviewed. Assessing if the reviewer followed business and compliance requirements as per the SOP. Identifying the gap and structuring the feedback. Having limited exposure with clients and/or Wipro management. Receiving moderate level instruction on daily work tasks and detailed instructions on new assignments. Making decisions that impact your own work and may impact the work of others. Being an individual contributor as a part of a team, with a focused scope of work. Having great attention to detail and a results-driven approach. Providing clear and crisp understanding of errors made by reviewers. Requirements: Fresher’s or 6 months experience in any Quality Review process. Good working knowledge of computer i.e., MS-Office (Google Sheets will be an added advantage). Good client management skills with an eye for detailing, proactively identifying gaps in processes and flagging them to internal leadership & client as appropriate. Good interpersonal & people management skills with a good problem-solving approach. Ability to exercise managerial judgment and perform as a mentor. Ability to multitask multiple activities by effective delegation and monitoring. Ability to work well under pressure. Client oriented, flexible, and patient. Excellent English written communication skills. Good organizational skills. Excellent verbal & written communication & presentation skills for experienced candidates. Good analytical skills for MIS, number crunching & reporting to internal & external customers. Demonstrated Customer Service Skills. Rotational shift including Saturday and Sunday working. Complete night shifts. Availability of 2-way cab. 5-day workweek with 2 days off. ? Deliver No.Performance ParameterMeasure1.AuditAdherence to the calendar; audit targets Compliance % as per audit reports – zero misses2.Process ComplianceCase targets – 2 hours/ week logged to be updated with the process ? As a Quality Assurance Analyst at Wipro Technologies, you will need to possess competencies such as Client Centricity, Passion for Results, Execution Excellence, Collaborative Working, Learning Agility, Problem Solving & Decision Making, and Effective Communication. ? Join Wipro Technologies as a Quality Assurance Analyst - L1 in the BPS-Analytics & Insights department. You will be a part of a dynamic team that values your contributions and empowers you to constantly evolve. Reinvent your world and realize your ambitions in a business that welcomes diversity and reinvention. Applications from individuals with disabilities are explicitly welcome. ? Mandatory Skills: QAAS(Advisory Services). Reinvent your world. We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career, and your skills. We want to see the constant evolution of our business and our industry. It has always been in our DNA - as the world around us changes, so do we. Join a business powered by purpose and a place that empowers you to design your own reinvention. Come to Wipro. Realize your ambitions. Applications from people with disabilities are explicitly welcome.
Posted 2 months ago
3 - 5 years
3 - 4 Lacs
Bengaluru, Delhi / NCR, Mumbai (All Areas)
Hybrid
- Analyze and review ads/videos that have been flagged for review of potentially sensitive content to ensure there are no violations of COPPA/CIPA policies. - General review of Movies/TV Shows episodical contents. - Data collection for Movies/TV Shows from various websites. - Review of Global Search Feed for Movies/Kids contents. By achieving all the above, you will be establishing the right customer experience and long-term strategy for increasing the traffic KPIs. Requirements: - Clear understanding of the kids audience segment and what videos/ads may be considered safe and not safe for them - Understanding of CIPA and COPPA compliance will be an added advantage - Outstanding American English listening, communication and comprehensive skills - Good vocabulary to understand the meaning of all words used in the videos/ads (to judge whether or not it is safe for kids viewing) - Good with various English accents, to be able to understand words pronounced differently - A fair understanding of the non-Kids segment of US audience and their preference - Basic understanding of new media, IPTV, Smart TV and mobile apps - Easily trainable with good grasping power and ability to scale up right after training - Ability to work on high volume tasks with tight deadlines, self-motivated and proactive - Result oriented and capable of multi-tasking - Someone, who is looking for a long time career relationship - Willingness to work on night shifts and weekends is a prerequisite. Perks and Benefits: Best in the Industry Important Links that you can look up are: http://futuretodayinc.com/ https://fawesome.tv/ https://happykids.tv/
Posted 2 months ago
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