4 Qc Review Jobs

Key Responsibilities: Conduct thorough quality control reviews of PBRER/PSURs, DSURs, PADER/PAERs, and other aggregate safety reports to ensure content accuracy, data integrity, formatting consistency, and adherence to regulatory and internal requirements. Verify correct incorporation of safety data, narratives, tables, and appendices, ensuring alignment with source documents and databases. Collaborate with Periodic Report Specialists to address discrepancies and ensure timely resolution of quality issues. Maintain up-to-date knowledge of global regulatory requirements and industry standard methodologies for periodic safety reporting. Contribute to the development and refinement of QC checklists, templates, and SOPs to ensure consistent review practices. Track QC metrics and support continuous improvement initiatives related to safety report quality and delivery. Responsible for performing QC reviews of periodic safety reports to ensure compliance with the style guide, templates, and contributor inputs. Responsible for verifying content accuracy, data integrity, and consistency across all report components. Responsible for collaborating with Periodic Report Specialist to resolve QC findings and ensure timely delivery of high-quality reports. Inspection Readiness: Support inspection readiness efforts by ensuring all QC activities are well-documented, traceable, and compliant with applicable regulatory requirements. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Bachelor s degree and 3 to 5 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Diploma and 7 to 9 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience Strong attention to detail with the ability to identify inconsistencies and errors in complex regulatory documents. Proven ability to operate effectively in a collaborative environment requiring coordination, communication, and analytical judgment. Solid understanding of pharmacovigilance principles and global regulatory requirements related to periodic aggregate reporting (e. g. , PBRERs, DSURs, PADERs). Proficiency in scientific and technical writing/editing, with an emphasis on quality control and adherence to style guides and templates. Excellent written and verbal communication skills in English, with strong organizational and time management abilities. Demonstrated ability to manage competing priorities and strict deadlines while maintaining high-quality standards. Familiarity with the structure and content of safety reports and the ability to interpret and validate data inputs from multiple contributors. Proficient in Microsoft Office tools (Word, Excel, PowerPoint), Adobe Acrobat, and document management systems (e. g. , Veeva Vault, SharePoint). Working knowledge of AI tools and prompt use is a plus, especially for enhancing QC efficiency. Team-oriented approach with the ability to work cross-functionally to support compliance and inspection readiness efforts. Contribution: Ensures Amgen remains in compliance and becomes best in class with regard to periodic aggregate report processes Implements and maintains document standards Responsible for successful tracking of metrics, timelines, and performance indicators for PASR objectives. Preferred Qualifications: Health Care Professional with minimum 2 - 3 years of relevant work experience Including 1 to 2 years of experience in periodic aggregate safety report writing

Job Description: As an Appraisal QC Reviewer in the Valuation/Appraisal QC department located in Chennai and working in the US Shift, you will report to the Team Lead. With 2-3 years of relevant experience and excellent communication skills, we are looking for candidates who can join with an immediate to 1-month notice period. In this role, you will be responsible for conducting detailed reviews of residential real estate appraisal reports. Your primary tasks will include ensuring accuracy, consistency, and completeness in the reports. You will need to identify any discrepancies, inconsistencies, or red flags and effectively communicate with internal teams or appraisers for clarification or corrections. Validating appraiser conclusions by reviewing market data such as comparable sales, listings, and subject property details will also be a key aspect of your role. Furthermore, you will be required to verify the presence and accuracy of all required exhibits like photos, maps, sketches, etc. Meeting daily and monthly productivity and quality targets set by management is crucial. Collaboration with Team Leads and other onshore departments to escalate and resolve critical issues will also be part of your responsibilities. It is essential for the ideal candidate to have hands-on experience with appraisal forms such as 1004 (Single-Family Residential), 1025 (Multi-Family), 1073 (Condominium), 2055 (Exterior-Only), and 1004C (Manufactured Home), among others.,

You are a dedicated and experienced Team Lead for the Document Review Services team at Epiq Global in Hyderabad, India. Your expertise in e-discovery, legal analysis, and project management will be crucial for overseeing document review projects, maintaining quality standards, and ensuring timely delivery aligned with client expectations. Your responsibilities include reviewing documents for relevancy, privilege, and other issues as directed by clients, conducting research on technical and industry-specific matters, drafting reports and findings, participating in QC reviews, creating complex searches, establishing review workflows based on client requirements, managing document review projects with teams ranging from 10-20 members, providing project status updates, escalating issues, and serving as the initial escalation point and SME for the project team. Key skills and competencies required for success in this role involve having a solid understanding of the document review and e-discovery/litigation industry, familiarity with litigation management software such as Relativity, Xerox, and/or DocuMatrix, industry-specific subject matter knowledge, proficiency in Microsoft Office tools, knowledge of the U.S. judicial system and legal procedures, excellent communication skills, strong analytical abilities, sound decision-making skills, commitment to maintaining quality standards, being a team player, displaying adaptability to changing needs and deadlines, demonstrating ethics and integrity, and the ability to work efficiently under pressure. Qualifications and experience necessary for this position include an LLB (three- or five-year program) or LLM (optional) from India or abroad, a minimum of 5+ years of document review experience, experience with contract management, hands-on experience with Relativity tools, at least 1+ years of experience managing a team as a Team Lead, and the flexibility to support U.S. business hours based on business requirements.,

Review and approval of analytical documents generated in the QC lab (e.g., STPs, COAs, protocols, reports). Perform thorough investigations related to out-of-specification (OOS), out-of-trend (OOT), deviations, and laboratory incidents in coordination with QC. Ensure timely closure of investigations with proper root cause identification and implementation of CAPA. Ensure compliance with cGMP, ICH guidelines, and other regulatory requirements. Support data integrity initiatives and audit readiness in the QC laboratory. Participate in internal and external audits, including those by USFDA and other regulatory bodies. Review and trend analytical data to ensure ongoing process verification and product quality. Collaborate with cross-functional teams (QC, Production, Regulatory Affairs, etc.) for continuous improvement. Desired Candidate Profile: Education: B.Pharm / M.Pharm / M.Sc in Chemistry or related field Experience: 10+ years of experience in Analytical Quality Assurance or QC in a pharmaceutical manufacturing environment, preferably in oral solid dosage (tablets) Hands-on experience in handling analytical investigations in a QC lab Experience in facing USFDA or other international regulatory audits Strong understanding of cGMP, ICH guidelines, and data integrity requirements Good communication and documentation skills