ql-editor "> Job Summary: The Contract & Proposal (C&P) professional will be responsible for managing the end-to-end process of drafting, negotiating, and finalizing proposals and contracts related to bioanalytical services. This role bridges scientific understanding with commercial acumen, ensuring timely, compliant, and competitive proposals are delivered to clients and sponsors in alignment with business objectives. Key Responsibilities: Collaborate with Business Development, Project Management, and Scientific teams to understand client requirements and scope of work. Prepare detailed technical and commercial proposals for bioanalytical services (e.g. PK/PD studies, method development & validation, sample analysis). Coordinate internal costing exercises and build accurate pricing models based on resource and timeline inputs. Draft, negotiate, and finalize various contract types (e.g., MSA, CDA, SOW, Work Orders) with clients. Review RFPs and RFIs, and prepare responses ensuring compliance with client guidelines and internal standards. Maintain a database of approved proposal templates, standard pricing modules, and contract clauses. Track proposal status, feedback, negotiations, and closure timelines in coordination with BD. Support audit and compliance documentation related to contracts and pricing. Ensure alignment with regulatory requirements (GLP/GCP), industry standards, and corporate policies in all documentation. Build strong relationships with external sponsors and internal cross-functional teams. Required Qualifications: Bachelor s or Master s degree in Life Sciences, Pharmacy, Chemistry, or related field. 2-7 years of experience in C&P or Proposal Development roles in a Bioanalytical or Clinical CRO. Strong understanding of bioanalytical lab services, GLP/GCP compliance, and clinical study structures. Proficiency in MS Excel, Word, and PowerPoint; experience with CRM tools is a plus. Excellent communication, negotiation, and writing skills. Detail-oriented with strong analytical and time management skills. Preferred Attributes: Experience dealing with international clients (US/EU/APAC) in a regulated environment. Ability to manage multiple proposals simultaneously with tight deadlines. Familiarity with regulatory frameworks (USFDA, EMA, DCGI) relevant to bioanalytical studies.
ql-editor "> Research Scientist The Analyst will be responsible for supporting bioanalytical studies within the clinical research domain, with a focus on method development, method validation, and routine sample analysis. The role requires strong technical expertise and adherence to established quality and regulatory standards. The selected candidate will actively contribute to the execution of bioanalytical projects in full compliance with GLP (Good Laboratory Practices), GCP (Good Clinical Practices), and all applicable regulatory guidelines. The Analysts will additionally be responsible for providing supervisory support, guiding junior team members, and taking on broader project leadership responsibilities.
ql-editor "> Job Description- Research Associate The Research Associate - Report Writer will be responsible for preparing clear, accurate, and compliant study reports for bioanalytical, clinical, and preclinical studies. The role requires strong scientific writing abilities, attention to detail, and the capability to work closely with cross-functional teams to ensure high-quality documentation aligned with SOPs, GLP, and global regulatory guidelines (FDA, EMA, OECD, ICH). Roles & Responsibilities Develop draft and final study reports for bioanalytical, clinical, or preclinical studies in accordance with SOPs, GLP, and applicable regulatory guidelines. Review raw data, analytical results, and statistical outputs for accuracy, completeness, and consistency prior to report preparation. Collaborate with Scientists, QA, and Project Managers to gather study details and ensure all relevant information is correctly represented in reports. Maintain version control, traceability, and organized documentation for all report drafts and related correspondence. Ensure reports meet sponsor expectations and adhere to internal CRO quality standards. Support the preparation of summary documents, method validation reports, and content for regulatory submissions (e.g., eCTD). Assist in addressing sponsor queries and regulatory audit requests related to study documentation. Maintain strict confidentiality, data integrity, and compliance throughout the reporting process. Apply strong scientific writing and editing skills to develop clear, precise, and well-structured reports. Demonstrate strong working knowledge of GLP, GCP, and regulatory requirements. Utilize proficiency in Microsoft Office tools (Word, Excel, PowerPoint) for report preparation and supporting documentation.
ql-editor "> Job Description- Research Associate Key Responsibilities: Conduct analytical testing of samples under supervision using instruments such as HPLC, GC, LC-MS/MS, and UV Spectrophotometer . Prepare reagents, solutions, and standards in accordance with approved Standard Operating Procedures (SOPs) . Record and maintain raw data, analytical logs, and reports accurately as per GLP/GMP requirements. Ensure all documentation meets regulatory, quality, and internal audit compliance standards. Support analytical method development and validation activities for pharmaceutical and biologic products. Assist in routine calibration, instrument upkeep, and troubleshooting under guidance. Participate actively in training programs to enhance technical skills and understanding of analytical techniques. Follow laboratory safety procedures and maintain a compliant, organized work area. Experience Required: 2-3 years of hands-on experience in an analytical laboratory environment. Working knowledge of GLP, GMP , and related quality systems (preferred). Exposure to analytical instrumentation such as HPLC, GC, LC-MS/MS, UV, etc.
ql-editor "> Job Description- Jr QC Reviewer The candidate will be responsible for reviewing analytical data and ensuring that all laboratory activities comply with approved procedures, regulatory guidelines, and data integrity requirements. The role involves thorough evaluation of test results, documentation, and instrument records to support accurate, reliable, and timely release of analytical reports. Roles & Responsibilities Review analytical raw data, chromatograms, worksheets, and test reports for accuracy, completeness, and compliance. Ensure all laboratory tests (assay, dissolution, content uniformity, stability, etc.) are performed and documented as per approved procedures. Verify calibration and qualification status of analytical instruments before use. Review instrument logbooks, usage records, and audit trail data for completeness and correctness. Check calculations, sample details, and batch information for accuracy. Ensure timely review and release of analytical reports to meet project and production timelines. Identify, document, and escalate data discrepancies, deviations, or non-conformances to the QC Manager. Support investigations related to out-of-specification (OOS), out-of-trend (OOT), or atypical results. Ensure compliance with SOPs, specifications, regulatory requirements, and data integrity standards. Participate in internal and external audits by providing required documentation and support. Contribute to continuous improvement initiatives within the Quality Control department.
ql-editor "> Job Description for Sr Research Associate Job Description: We are looking for skilled Sr Research Associate with 3-5 years of experience in the clinical research domain, specializing in Extractables & Leachable (E&L) and Elemental analytical studies. The role involves supporting method development, method validation, and sample analysis while ensuring full compliance with GLP, GCP, Q1/Q2 guidelines , and all applicable regulatory standards. Roles and Responsibilities The Analyst and Senior Analyst will support analytical studies in the clinical research domain, focusing on analytical method development, validation, and sample analysis of E & L / Elemental . The candidates will contribute to the execution of analytical projects in compliance with Q1, Q2 residual analysis, GLP (Good Laboratory Practices), GCP (Good Clinical Practices), and applicable regulatory requirements. Senior Analysts will have more supervisory and project leadership responsibilities. Maintain accurate and complete documentation, including lab notebooks, SOPs, protocols, and reports. Process raw data and generate reports for study documentation and regulatory submission. Troubleshoot bioanalytical methods and equipment issues, providing solutions to improve performance. Oversee and implement quality control measures for all bioanalytical processes, including internal audits.
ql-editor "> Job Description- Jr QA Auditor We are seeking a detail-oriented and quality-focused professional to support and strengthen our Quality Management System (QMS). The role involves reviewing documentation, coordinating trainings, ensuring compliance across processes, and supporting regulatory and sponsor audits. Roles & Responsibilities Documentation & QMS Oversight Review Quality Management System documents, including Quality Manual, SOPs, and technical SOPs, for accuracy and compliance. Issue, control, and maintain documents as per the Document Management System. Review instrument qualification and calibration certificates, as well as computerized system validation (CSV) documents. Ensure computerized systems used at any stage of analysis remain in a validated state and verify electronic data and audit trails. Training Coordination Act as the Training Coordinator and execute all training-related activities as required by the training software/system. Conduct training sessions on QMS-related documents such as SOPs and Quality Policy. Sample & Data Management Ensure all procedures related to sample management including sample receipt, pharmacy, and sample retention are performed as per approved guidelines. Review study/project documents such as protocols, raw data, reports, and STPs for adequacy and accuracy. Quality Compliance & Audits Plan and conduct system audits and study audits to verify adherence to approved procedures. Review quality tools such as incidents, deviations, change controls, OOS, repeat analysis, and CAPA as per respective SOPs. Participate in regulatory and sponsor audits and support timely preparation and submission of responses.
ql-editor "> Key Responsibilities Manual Testing Test Design & Execution: Design, develop, and execute detailed manual test cases and test scripts based on product requirements, design specifications, and user stories. Functional Testing: Perform thorough functional, system, integration, and regression testing on various platforms (web, mobile, desktop) to ensure features work as intended. Exploratory Testing: Conduct exploratory testing to uncover issues and defects not easily found by scripted tests, leveraging a user-centric perspective. Defect Management: Identify, document, and track software defects and issues reproducible steps and communicating findings to the development team. Usability & Performance: Perform basic usability and accessibility checks. Automation Testing Framework Development: Design, develop, and maintain robust test automation frameworks and libraries (e.g., using Selenium, Playwright, Cypress) for functional and regression testing. Scripting: Write, update, and debug high-quality, reusable automation test scripts using programming languages like C#(preferable), Java, Python, or JavaScript . API Testing: Design and execute automated tests for APIs/Web Services using tools like Postman, REST Assured, or SoapUI. Analysis: Execute automated test suites, analyse results, and effectively report on test execution status and coverage. Collaboration & Process Requirements Review: Collaborate with Developer / Product Owners / Business Analysts to review and analyse requirements and design documents to ensure clarity, testability, and completeness. Documentation: Create and maintain comprehensive test documentation, including Test Plans, Test Strategies, test cases , and test summary reports. Root Cause Analysis: Participate in root cause analysis for critical defects to help identify process gaps and drive preventative measures. Required Qualifications & Skills Bachelors degree in Computer Science, Information Technology, or equivalent. Minimum [2] years of experience in software testing with proven expertise in both manual and automation testing. Strong understanding of Software Development Lifecycle (SDLC) Proficiency in at least one programming/scripting language ( Java, Python, C# (preferable), or JavaScript ). Hands-on experience with industry-standard test automation tools ( Selenium WebDriver, TestNG/JUnit, etc. ). Experience with Git or other version control systems. Solid knowledge of SQL and database concepts for back-end testing. Excellent analytical, problem-solving, and communication skills . Required Skills Automation Testing Manual Testing Software Testing
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