Job Summary We are looking for a versatile Analyst focusing on our In Vitro segment with experience in one or more of our in vitro services, such as IVRT, IVPT, in vitro bioequivalence (BE) studies, BCS biowaivers, enteral feeding tube studies, or in vitro statistical analysis. While expertise in all these areas is not required, candidates should have a strong foundation in in vitro techniques, regulatory guidelines (eg: FDA, EMA), and data interpretation to support pharmaceutical product development. Key Responsibilities Conduct or support one or more of the following: In vitro release testing (IVRT) and in vitro permeation testing (IVPT) for pharmaceutical formulations. In vitro bioequivalence studies and BCS biowaiver studies as per regulatory standards. Enteral feeding tube studies to assess drug administration compatibility. Analysis and interpretation of data from in vitro studies, applying statistical methods where required. Ensure compliance with FDA, EMA, ICH, and USP guidelines in laboratory procedures. Prepare and review study protocols, scientific reports, and regulatory documentation. Collaborate with cross-functional teams, including regulatory affairs and bioanalytical scientists. Maintain laboratory equipment, follow SOPs, and ensure GLP/GMP compliance. Basic understanding of statistical analysis for in vitro studies is a plus. Qualifications & Skills Education: Bachelor’s, Master’s or Ph.D. in Pharmaceutical Sciences, Biopharmaceutics, Analytical Chemistry, or a related field. Experience: At least 2 years of experience in any in vitro research area, preferably within a CRO or pharmaceutical company. Soft Skills Strong analytical and problem-solving abilities. Excellent written and verbal communication skills. Ability to learn quickly and adapt to new in vitro methodologies. Why Join Us? Work with a leading CRO specializing in diverse in vitro research areas. Gain exposure to multiple in vitro techniques and expand your expertise. Collaborative and growth-oriented work environment. If you are eager to develop expertise in in vitro research and contribute to high-impact pharmaceutical studies, we encourage you to apply! Show more Show less
The Bioanalytical Analyst and Senior Analyst will support bioanalytical studies in the clinical research domain, focusing on bioanalytical method development, validation, and sample analysis. The candidates will contribute to the execution of bioanalytical projects in compliance with GLP (Good Laboratory Practices), GCP (Good Clinical Practices), and applicable regulatory requirements. Senior Analysts will have more supervisory and project leadership responsibilities. Key Responsibilities Analyst I/II (3-5 Years of Experience) Bioanalytical Method Development: Assist in developing and optimizing bioanalytical methods, including LC-MS/MS, HPLC, and other analytical techniques. Sample Preparation: Conduct bioanalytical sample preparation, including extraction techniques such as protein precipitation, liquid-liquid extraction, and solid-phase extraction. Method Validation: Assist in bioanalytical method validation following regulatory guidelines (FDA, EMA) for clinical trials. Sample Analysis: Perform bioanalysis of clinical samples such as plasma, serum, urine, etc., ensuring accuracy, precision, and reliability of results. Documentation: Maintain accurate and complete documentation, including lab notebooks, SOPs, protocols, and reports. Compliance: Follow Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) to ensure data integrity. Data Analysis: Process raw data and generate reports for study documentation and regulatory submission. Equipment Maintenance: Operate and maintain laboratory equipment, ensuring proper calibration and troubleshooting as necessary. Senior Analyst I/II (5-8 Years of Experience) In Addition To The Responsibilities Mentioned For Analyst I/II Project Management: Lead and manage bioanalytical projects, ensuring timely and accurate delivery of results. Supervision: Mentor junior analysts and provide technical guidance to ensure best practices in bioanalytical processes. Regulatory Compliance: Ensure all bioanalytical activities are compliant with regulatory standards (FDA, EMA, etc.) and maintain audit readiness. Client Interaction: Collaborate with sponsors, clients, and cross-functional teams to meet project goals and expectations. Method Troubleshooting: Troubleshoot bioanalytical methods and equipment issues, providing solutions to improve performance. Reporting & Review: Review data analysis reports generated by junior team members, ensuring accuracy and regulatory compliance. Quality Control: Oversee and implement quality control measures for all bioanalytical processes, including internal audits. Show more Show less
The Quality Control (QC) Reviewer plays a crucial role in ensuring the accuracy, completeness, and compliance of laboratory and clinical data with regulatory guidelines, company policies, and industry standards. Your responsibilities include reviewing raw data, study documentation, and analytical reports to ensure adherence to protocols and regulatory requirements. By identifying discrepancies and errors, you will provide recommendations for corrective actions to maintain data integrity. Collaboration with laboratory analysts, study coordinators, and quality assurance teams is essential to resolve issues related to data accuracy and compliance. As a QC Reviewer, you will document your findings meticulously, preparing detailed reports for management and regulatory bodies. Additionally, you will participate in audits and inspections to uphold quality standards. To excel in this role, you should hold a Bachelors/Masters degree in Life Sciences, Pharmacy, Chemistry, or a related field. With 2-6 years of experience in Quality Control/Quality Assurance within the pharmaceutical or biotech industry, you are expected to have a strong understanding of GLP, GCP, FDA, EMA, and ICH guidelines. Proficiency in reviewing analytical data, clinical study reports, and laboratory documentation, along with excellent attention to detail and problem-solving skills, are essential. Effective communication and interpersonal skills are necessary to collaborate with cross-functional teams. Moreover, staying updated with regulatory changes and industry best practices will contribute to enhancing the organization's quality standards. Experience with bioanalytical, clinical, or preclinical study reviews, knowledge of electronic data capture (EDC), and the ability to handle multiple projects with tight deadlines are preferred skills for this role. Proficiency in Microsoft Office and Laboratory Information Management Systems (LIMS) would be advantageous.,
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.
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. You will collaborate with Business Development, Project Management, and Scientific teams to understand client requirements and scope of work. Your responsibilities will include preparing detailed technical and commercial proposals for bioanalytical services such as PK/PD studies, method development & validation, and sample analysis. Additionally, you will coordinate internal costing exercises and build accurate pricing models based on resource and timeline inputs. In this role, you will draft, negotiate, and finalize various contract types (e.g., MSA, CDA, SOW, Work Orders) with clients. You will review RFPs and RFIs, and prepare responses ensuring compliance with client guidelines and internal standards. Maintaining a database of approved proposal templates, standard pricing modules, and contract clauses will also be part of your duties. Tracking proposal status, feedback, negotiations, and closure timelines in coordination with BD, as well as supporting audit and compliance documentation related to contracts and pricing, are crucial aspects of this role. Ensuring alignment with regulatory requirements (GLP/GCP), industry standards, and corporate policies in all documentation is essential. Building strong relationships with external sponsors and internal cross-functional teams is key to success in this role. Required Qualifications: - Bachelors or Masters 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.,
As a Full-stack Engineer on our team, you will play a pivotal role in shaping both the backend and frontend of our product. If you're excited about taking ownership of the entire stack, making key technical decisions, and creating exceptional user experiences, this role is for you. Specialized in a specific part of the stack We value depth as much as versatility so don't hesitate to reach out. Design, develop, and maintain RESTful APIs, socket-based APIs and backend services using Node.js. Build and optimize scalable database systems with PostgreSQL to handle large-scale traffic and data. Architect and maintain our AWS infrastructure to ensure scalability, reliability, and security. Collaborate with front-end developers to integrate APIs seamlessly with the user interface. Develop responsive and visually stunning user interfaces using React.js, ensuring a smooth and intuitive user experience. Take ownership of UI/UX design decisions, making sure the product is both functional and aesthetically pleasing. Implement web scraping solutions to gather and integrate data from external sources. Ensure code quality through testing, debugging, and performance tuning across the stack. Lead technical discussions and contribute to architectural decisions for both backend and frontend systems. Join a fast-paced start-up environment where you'll have the opportunity to learn, grow, and make a significant impact. Work on challenging problems that require innovative solutions, collaborating with a talented and driven team. Enjoy a culture of continuous improvement, where your ideas and contributions are valued and rewarded. BS/MS degree in Computer Science, Engineering, or a related subject.,
As an Android App Developer, you will be an integral part of our dynamic team, contributing to the design, coding, testing, and debugging of mobile applications specifically for the Android operating system. Your responsibilities will include collaborating with the founding team to create the Android application from scratch, implementing user interfaces and features to enhance the user experience, and ensuring the application stays current with industry trends and technologies for continuous improvement. You will actively participate in code reviews, offering valuable feedback to maintain high-quality and coherent code. Additionally, you will conduct unit tests to ensure the robustness, usability, and reliability of the codebase, focusing on bug fixes and optimization of application performance. The ideal candidate should possess around 2 years of hands-on experience in Android app development, hold a degree in Computer Science, Engineering, or a related field, and have successfully published at least one Android app on the Google Play Store. Proficiency in Kotlin, knowledge of Android SDK, Google Maps, and Firebase are essential. Understanding Android UI design principles, architecture, and best practices is crucial, along with familiarity with Agile development methodologies, third-party libraries/APIs integration, and version control systems like Git. Being well-versed in Android Architecture, Core Java, Android Studio IDE, and Android Debugger is necessary. A solid grasp of the mobile development life cycle, along with the ability to work both independently and collaboratively in a fast-paced startup environment, is expected. Strong problem-solving and communication skills are paramount for success in this role. Previous experience in a startup environment is considered a bonus. If you are passionate about Android app development and eager to contribute your expertise to our team, we look forward to receiving your application.,
As a meticulous and motivated QA Analyst, you will play a crucial role in ensuring the quality and reliability of our systems and processes. Your responsibilities will include conducting comprehensive audits, testing procedures, and ensuring compliance with regulatory standards. Your attention to detail, effective communication skills, and ability to collaborate in a dynamic environment will be key to your success in this role. You will be expected to perform quality assurance audits by conducting system process audits to identify inconsistencies and areas for improvement. Additionally, you will be responsible for developing, reviewing, and updating quality standards to align with industry best practices. Your contribution to creating, updating, and evaluating test cases will be essential in both manual and automated testing efforts to guarantee optimal system performance. Furthermore, you will be required to develop, update, and maintain software documentation, standard operating procedures (SOPs), validation documentation, and other technical materials. Ensuring compliance with relevant regulatory requirements such as CSV, 21 CFR Part 11, EU regulations, GxP, and GMP standards will be a critical aspect of your role. To excel in this position, you should possess the ability to quickly learn and adapt to new tools and processes. Strong verbal communication and coaching skills, along with excellent written communication skills for clear documentation, will be essential. Your proven ability to work effectively in a team environment, goal-oriented mindset, exceptional time management skills, and flexibility in adapting to changing project requirements and timelines will be valuable assets. Preferred qualifications for this role include experience with manual and automated testing tools, familiarity with quality assurance frameworks and methodologies, as well as knowledge of regulatory compliance standards in relevant industries.,
As an Analytical Chemist at our leading Contract Research Organization (CRO), you will have the opportunity to assist in conducting analytical testing of samples using instruments such as HPLC, GC, LC-MS/MS, and UV Spectrophotometer under supervision. You will play a crucial role in preparing reagents, solutions, and standards following Standard Operating Procedures (SOPs) with precision and attention to detail. Your responsibility will include accurately recording and maintaining raw data, logs, and reports in compliance with GLP/GMP standards. By ensuring proper documentation, you will play a pivotal role in meeting regulatory and internal audit requirements. You will provide essential support in method development and validation for pharmaceuticals and biologics. Under the guidance of senior analysts, you will contribute to stability studies and impurity profiling, gaining valuable hands-on experience in the field. Learning and assisting in calibrating and maintaining analytical instruments will be part of your routine tasks. Following preventive maintenance schedules diligently and promptly reporting any malfunctions will be essential in ensuring the smooth functioning of instruments. Adhering to GLP, GMP, and regulatory guidelines while performing your assigned tasks will be crucial. Your active participation in audits and commitment to maintaining compliance with safety and quality standards will be highly valued. You will have the opportunity to enhance your proficiency in analytical techniques through active participation in training sessions. Staying informed about new methodologies, instruments, and advancements in the field will be key to your professional development. We are looking for candidates with a background in M.Sc. (Analytical Chemistry, Organic Chemistry, or related field), M.Pharm, or B.Pharm with practical academic experience. A basic understanding of analytical techniques and foundational knowledge of instruments like HPLC, LC-MS, or GC is desirable. Familiarity with GLP and GMP guidelines will be an advantage. Strong analytical and critical thinking abilities, effective communication and teamwork skills, and enthusiasm for learning and adapting to new challenges are essential soft skills we are seeking in potential candidates. Joining us will provide you with the opportunity to kickstart your career in a structured training environment, tailored to help freshers transition into a professional analytical setting. You will gain hands-on experience with advanced analytical instruments and methodologies, along with clear career progression paths and professional development programs.,
As an Analyst focusing on the In Vitro segment, your role will involve working with various in vitro services such as IVRT, IVPT, in vitro bioequivalence (BE) studies, BCS biowaivers, enteral feeding tube studies, or in vitro statistical analysis. While expertise in all these areas is not mandatory, you should have a solid foundation in in vitro techniques, regulatory guidelines (e.g., FDA, EMA), and data interpretation to support pharmaceutical product development. **Key Responsibilities:** - Conduct or support in vitro release testing (IVRT) and in vitro permeation testing (IVPT) for pharmaceutical formulations. - Perform in vitro bioequivalence studies and BCS biowaiver studies according to regulatory standards. - Conduct enteral feeding tube studies to evaluate drug administration compatibility. - Analyze and interpret data from in vitro studies, utilizing statistical methods when necessary. - Ensure adherence to FDA, EMA, ICH, and USP guidelines in laboratory procedures. - Prepare and review study protocols, scientific reports, and regulatory documentation. - Collaborate with cross-functional teams, including regulatory affairs and bioanalytical scientists. - Maintain laboratory equipment, follow SOPs, and ensure GLP/GMP compliance. - Basic understanding of statistical analysis for in vitro studies is advantageous. **Qualifications & Skills:** - Education: Bachelors, Masters, or Ph.D. in Pharmaceutical Sciences, Biopharmaceutics, Analytical Chemistry, or a related field. - Experience: Minimum of 2 years of experience in any in vitro research area, preferably within a CRO or pharmaceutical company. **Soft Skills:** - Strong analytical and problem-solving abilities. - Excellent written and verbal communication skills. - Quick learning capability and adaptability to new in vitro methodologies. If you are passionate about developing expertise in in vitro research and contributing to impactful pharmaceutical studies, we invite you to join us. As a leading CRO specializing in diverse in vitro research areas, you will have the opportunity to work in a collaborative and growth-oriented environment, gain exposure to multiple in vitro techniques, and expand your expertise.,
Role Overview: As a Full-stack Engineer on the team, you will play a pivotal role in shaping both the backend and frontend of the product. If you're excited about taking ownership of the entire stack, making key technical decisions, and creating exceptional user experiences, this role is for you. We value depth as much as versatility, so don't hesitate to reach out if you are specialized in a specific part of the stack. Key Responsibilities: - Design, develop, and maintain RESTful APIs, socket-based APIs, and backend services using Node.js. - Build and optimize scalable database systems with PostgreSQL to handle large-scale traffic and data. - Architect and maintain our AWS infrastructure to ensure scalability, reliability, and security. - Collaborate with front-end developers to integrate APIs seamlessly with the user interface. - Develop responsive and visually stunning user interfaces using React.js, ensuring a smooth and intuitive user experience. - Take ownership of UI/UX design decisions, making sure the product is both functional and aesthetically pleasing. - Implement web scraping solutions to gather and integrate data from external sources. - Ensure code quality through testing, debugging, and performance tuning across the stack. - Lead technical discussions and contribute to architectural decisions for both backend and frontend systems. Qualifications Required: - BS/MS degree in Computer Science, Engineering, or a related subject. (Note: No additional details about the company were provided in the job description.),
As a QA Analyst at our company, you will play a crucial role in ensuring the quality and reliability of our systems and processes. Your attention to detail, communication skills, and ability to work collaboratively will be essential for the success of our team. **Key Responsibilities:** - **Perform Quality Assurance Audits:** Conduct thorough system process audits to identify inconsistencies and areas for improvement. - **Quality Standards Development:** Develop, review, and update quality standards to align with industry best practices. - **Testing Processes:** Create, update, and evaluate test cases for both manual and automated testing efforts to optimize system performance. - **Documentation:** Develop, update, and maintain software documentation, SOPs, validation documentation, and technical materials. - **Regulatory Compliance:** Ensure compliance with relevant regulatory requirements such as CSV, 21 CFR Part 11, EU regulations, GxP, and GMP standards. **Qualifications Required:** - Quick learner with the ability to adapt to new tools and processes. - Strong verbal communication and coaching skills. - Excellent written communication skills for clear and concise documentation. - Proven ability to work effectively in a team environment. - Goal-oriented mindset with a focus on achieving the organization's mission and vision. - Exceptional time management skills for task prioritization and meeting deadlines. - Flexible working approach to adapt to changing project requirements and timelines. In addition to the above responsibilities and qualifications, preferred experience for this role includes: - Experience with manual and automated testing tools. - Familiarity with quality assurance frameworks and methodologies. - Knowledge of regulatory compliance standards in relevant industries. Join us in our mission to maintain high-quality standards and ensure the reliability of our systems through your meticulous approach and collaborative spirit.,
Role Overview: As a Sample Analyst, your primary responsibility will be to assist in conducting analytical testing of samples using instruments such as HPLC, GC, LC-MS/MS, and UV Spectrophotometer under supervision. You will also be involved in preparing reagents, solutions, and standards as per Standard Operating Procedures (SOPs). Key Responsibilities: - Accurately record and maintain raw data, logs, and reports following GLP/GMP standards. - Provide support in method development and validation for pharmaceuticals and biologics. - Learn and assist in calibrating and maintaining analytical instruments. - Adhere to GLP, GMP, and regulatory guidelines while performing assigned tasks. - Actively participate in training sessions to develop proficiency in analytical techniques. Qualification Required: - M.Sc. in Analytical Chemistry, Organic Chemistry, or related field, M.Pharm, or B.Pharm with practical academic experience. - Basic understanding of analytical techniques and foundational knowledge of instruments like HPLC, LC-MS, or GC is desirable. - Familiarity with GLP and GMP guidelines is an advantage. - Strong analytical and critical thinking abilities. - Effective communication and teamwork skills. - Enthusiastic learner with adaptability to new challenges. Additional Details: If you join us, you will begin your career in a leading Contract Research Organization (CRO) with excellent learning opportunities. You will gain hands-on experience with advanced analytical instruments and methodologies. Moreover, there are clear career progression paths and professional development programs available. Please note that this is an entry-level role designed to provide structured training and guidance to help freshers transition into a professional analytical environment. Role Overview: As a Sample Analyst, your primary responsibility will be to assist in conducting analytical testing of samples using instruments such as HPLC, GC, LC-MS/MS, and UV Spectrophotometer under supervision. You will also be involved in preparing reagents, solutions, and standards as per Standard Operating Procedures (SOPs). Key Responsibilities: - Accurately record and maintain raw data, logs, and reports following GLP/GMP standards. - Provide support in method development and validation for pharmaceuticals and biologics. - Learn and assist in calibrating and maintaining analytical instruments. - Adhere to GLP, GMP, and regulatory guidelines while performing assigned tasks. - Actively participate in training sessions to develop proficiency in analytical techniques. Qualification Required: - M.Sc. in Analytical Chemistry, Organic Chemistry, or related field, M.Pharm, or B.Pharm with practical academic experience. - Basic understanding of analytical techniques and foundational knowledge of instruments like HPLC, LC-MS, or GC is desirable. - Familiarity with GLP and GMP guidelines is an advantage. - Strong analytical and critical thinking abilities. - Effective communication and teamwork skills. - Enthusiastic learner with adaptability to new challenges. Additional Details: If you join us, you will begin your career in a leading Contract Research Organization (CRO) with excellent learning opportunities. You will gain hands-on experience with advanced analytical instruments and methodologies. Moreover, there are clear career progression paths and professional development programs available. Please note that this is an entry-level role designed to provide structured training and guidance to help freshers transition into a professional analytical environment.
JD for Project Management / Business Development (CRO) Roles And Responsibilities PRINCIPAL DUTIES AND RESPONSIBILITIES: Note: These statements reflect the general description of the position and are not intended to be an all-inclusive list of tasks to which the employee may be assigned. I. Project Related Activities Responsible for project management related tasks as indicated: Facilitate project set-up, scheduling budgeting and release of all projects as indicated. Prepare project management documentation for sponsor identification and/or approval. Responsible for investigating and completing required documentation to ensure appropriate approvals are in place before execution of study. Maintain and keep status on a monthly basis for all analytical methods and invitro Bioequivalence studies completed. Attend teleconferences as scheduled for projects and ensure effective communication of project milestones/activities. Understands time-sensitive nature of critical path project activities and notifies the relevant teams, and/or management of related issues. Works with management to establish project interim milestones and ensures projects are on schedule to ensure our report structure/compilation is communicated and assist where required. Working with Finance, address any discrepancies with client’s invoices in a timely manner. Demonstrates well-developed project management skills by utilizing the relevant information, project management methodologies and processes to assist in planning, coordinating, and monitoring of all projects. Utilizes advanced problem-solving techniques to identify root causes of problems/issues and provides suggestions for the best course of action in consultation with management. Demonstrates the ability to make complex interpretation and application decisions within role capacity by utilizing protocol, Standard Operating Procedures (SOPs) and/or other tools deemed appropriate. Participates in on-going educational activities to enhance own knowledge level as well as that of other team members. Performs other duties as assigned by department management as training experience allows. To ensure appropriate approvals/agreements are in place before execution of study. On need basis, assist team members in their daily activities. Ii. General Duties Works with Associate Director, Commercial to establish the unit strategy and furnish allocated duties on priority bases ensuring compliance with required standards. Recommends, develops and participates in the development or revision of internal procedures and standards with impact to department. Recognizes issues and takes appropriate corrective actions, consulting with appropriate staff as required. Fosters and maintains effective working relationships with all clients and functional units within Vitely. Iii. Administrative Duties Confirms to training schedule for own position and maintains awareness of SOP content, according to company requirements. Stays current with the ongoing changes in the pharmaceutical regulatory environment, i.e. FDA, GxPs, GLPs, etc. Iv. Additional Activities To ensure proper query response in stipulated timelines for the submitted applications in coordination with respective managers. Responsible to maintain the Project tracking sheet of all the awarded/ongoing projects. Responsible for generating MSS on a weekly basis. Weekly meeting with all internal stakeholders for timeline/status of all ongoing/upcoming studies. Any Additional responsibilities given by Head of Department / Management BD Related Tasks To visit sponsors for acquiring new projects and show case services To attend National & International forums
As a Report Writer, your role involves preparing high-quality scientific and technical reports, such as clinical study reports (CSRs), bioanalytical reports, and regulatory submission documents. You are responsible for ensuring that all reports adhere to regulatory guidelines, industry standards, and internal SOPs while effectively communicating scientific findings. Key Responsibilities: - Prepare and review various scientific and technical reports, including clinical study reports, bioanalytical reports, and method validation reports. - Ensure clarity, accuracy, and compliance of reports with regulatory requirements such as FDA, EMA, ICH, Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) standards. - Collaborate closely with scientists, analysts, statisticians, and quality assurance teams to interpret data accurately and present study results effectively. - Format reports according to client specifications and regulatory submission requirements. - Maintain version control and monitor report progress to ensure timely completion of deliverables. - Conduct quality control (QC) checks on reports to identify inconsistencies, errors, or deviations from standard practices. - Assist in preparing summaries, manuscripts, and other scientific documents for publication or regulatory submission. - Keep abreast of regulatory guidelines, industry best practices, and emerging trends in medical and regulatory writing. Qualifications & Experience: - Bachelors/Masters degree in Life Sciences, Pharmacy, Biochemistry, or a related field. - 2-6 years of experience in medical writing, regulatory writing, or scientific writing within a Contract Research Organization (CRO), pharmaceutical, or biotech industry. - Strong knowledge of GLP, GCP, and ICH guidelines related to clinical and bioanalytical reporting. - Excellent writing, editing, and proofreading skills with high attention to detail. - Ability to interpret scientific data and present it clearly and concisely. - Proficiency in Microsoft Office (Word, Excel, PowerPoint) and document management systems. - Strong organizational and time management skills to handle multiple projects and meet tight deadlines. Preferred Skills: - Experience with regulatory submissions, clinical protocols, and investigator brochures. - Familiarity with statistical concepts and data analysis tools. - Knowledge of electronic submission processes and regulatory writing software. As a Report Writer, your role involves preparing high-quality scientific and technical reports, such as clinical study reports (CSRs), bioanalytical reports, and regulatory submission documents. You are responsible for ensuring that all reports adhere to regulatory guidelines, industry standards, and internal SOPs while effectively communicating scientific findings. Key Responsibilities: - Prepare and review various scientific and technical reports, including clinical study reports, bioanalytical reports, and method validation reports. - Ensure clarity, accuracy, and compliance of reports with regulatory requirements such as FDA, EMA, ICH, Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) standards. - Collaborate closely with scientists, analysts, statisticians, and quality assurance teams to interpret data accurately and present study results effectively. - Format reports according to client specifications and regulatory submission requirements. - Maintain version control and monitor report progress to ensure timely completion of deliverables. - Conduct quality control (QC) checks on reports to identify inconsistencies, errors, or deviations from standard practices. - Assist in preparing summaries, manuscripts, and other scientific documents for publication or regulatory submission. - Keep abreast of regulatory guidelines, industry best practices, and emerging trends in medical and regulatory writing. Qualifications & Experience: - Bachelors/Masters degree in Life Sciences, Pharmacy, Biochemistry, or a related field. - 2-6 years of experience in medical writing, regulatory writing, or scientific writing within a Contract Research Organization (CRO), pharmaceutical, or biotech industry. - Strong knowledge of GLP, GCP, and ICH guidelines related to clinical and bioanalytical reporting. - Excellent writing, editing, and proofreading skills with high attention to detail. - Ability to interpret scientific data and present it clearly and concisely. - Proficiency in Microsoft Office (Word, Excel, PowerPoint) and document management systems. - Strong organizational and time management skills to handle multiple projects and meet tight deadlines. Preferred Skills: - Experience with regulatory submissions, clinical protocols, and investigator brochures. - Familiarity with statistical concepts and data analysis tools. - Knowledge of electronic submission processes and regulatory writing software.
As a QA Analyst at our company, you will play a crucial role in ensuring the quality and reliability of our systems and processes. Your attention to detail, strong communication skills, and ability to collaborate effectively in a dynamic environment will be key to your success in this position. Key Responsibilities: - Conduct Quality Assurance Audits: You will be responsible for conducting audits of our system processes to identify any inconsistencies and areas for improvement. - Develop Quality Standards: You will play a vital role in developing, reviewing, and updating quality standards to ensure they align with industry best practices. - Testing Processes: Your role will involve creating, updating, and evaluating test cases for both manual and automated testing efforts to maintain optimal system performance. - Documentation: You will be in charge of developing, updating, and maintaining software documentation, SOPs, validation documentation, and other technical materials. - Regulatory Compliance: Ensuring adherence to relevant regulatory requirements such as CSV, 21 CFR Part 11, EU regulations, GxP, and GMP standards will be a critical part of your responsibilities. Qualifications Required: - Quick learner with the ability to adapt to new tools and processes. - Strong verbal communication and coaching skills. - Excellent written communication skills for clear and concise documentation. - Proven ability to work effectively in a team environment. - Goal-oriented mindset with a focus on achieving the organization's mission and vision. - Exceptional time management skills to prioritize tasks and meet deadlines. - Flexible working approach, capable of adapting to changing project requirements and timelines. In addition to the above responsibilities and qualifications, the following preferred experience would be beneficial for the role: - Experience with manual and automated testing tools. - Familiarity with quality assurance frameworks and methodologies. - Knowledge of regulatory compliance standards in relevant industries.,
As a Contract & Proposal (C&P) professional, your role involves managing the end-to-end process of drafting, negotiating, and finalizing proposals and contracts related to bioanalytical services. You will bridge scientific understanding with commercial acumen to deliver timely, compliant, and competitive proposals 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 such as PK/PD studies, method development & validation, and sample analysis. - Coordinate internal costing exercises and develop 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 ensure responses comply 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 Business Development. - Support audit and compliance documentation related to contracts and pricing. - Ensure compliance 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 a 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.,
Job Description Job Description for Sr Research Associate 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.
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.
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.