As a Clinical QA Auditor, you will be responsible for planning, conducting, and managing internal audits (Study Inprocess & Retrospective, System Audit) and Vendor audits in compliance with ICH-GCP, Protocol, SOPs, and applicable GxP standards/regulations. Your role will involve preparing audit reports, reviewing SOPs, study protocols, and clinical study reports, as well as assessing responses to audit findings and negotiating suitable actions for resolution. You will also be involved in reviewing deviations and CAPA plans, ensuring their implementation and closure, assisting in preparing the facility for client/sponsor audits and regulatory inspections, and performing document reconciliation for both Project and Non-project related documents. Additionally, you will review equipment calibration/validation records to maintain quality standards. To excel in this role, you should possess strong written and verbal communication skills, along with excellent analytical and problem-solving abilities. Good computer skills are essential, and being self-motivated with the ability to effectively prioritize work tasks is crucial. The ideal candidate will have a background in Life Sciences (B.Sc/M.Sc/B.Pharm/M.Pharm) and at least 2-5 years of experience in GCP quality assurance audits. A comprehensive understanding of ICH-GCP, US and EU regulations, and applicable GxP standards/regulations is required to ensure compliance and quality in auditing processes.,
As a Junior Research Associate in the Bioanalytical Research field, your responsibilities will include the operation and maintenance of various laboratory equipment. You will be required to handle biological samples, manage sample receipt and shipment, and procure biological matrix lots as needed. Additionally, you will be responsible for the operation, calibration, and maintenance of equipment such as deep freezers, refrigerators, Eurotherm, Thermo hygrometers, thermometers, centrifuge, evaporator, pH meter, balance, and pipettes. Furthermore, you will be involved in the management of biological samples including study samples, validation samples, and matrix lots. It will be crucial for you to maintain and archive relevant data in accordance with Standard Operating Procedures (SOPs) in coordination with the QC associate. The ideal candidate for this position should hold a B.Pharm or B.Sc. in Lifescience and possess 0-6 years of relevant experience. Strong attention to detail, organizational skills, and the ability to work effectively in a team are essential for success in this role.,
As a Lab Technician in the Clinical Pathology Laboratory located in Hyderabad, you will be expected to have 2-5 years of experience in the field of Medical Laboratory. Your primary responsibility will be to work within the Clinical Pathology Laboratory department, utilizing your qualifications in DMLT or BSC in MLT to contribute effectively to the team. Join us in this dynamic environment where your expertise will be valued and where you can make a meaningful impact in the field of healthcare.,
As a Junior Research Associate (Custodian) in the field of Bioanalytical Research, you will be responsible for the following key tasks: - Operating Deep freezers, Refrigerators, Eurotherm, Thermo hygrometers, and Thermometers to ensure proper storage conditions for biological samples. - Handling the receipt and shipment of biological samples to and from other facilities, ensuring accuracy and timely delivery. - Managing various types of biological samples including study samples, validation samples, and matrix lots with precision and care. - Procuring and handling biological matrix lots according to specific requirements and guidelines. - Maintaining and managing Columns, working, and reference standards to support research activities. - Operating, calibrating, and maintaining laboratory equipment such as Centrifuge, Evaporator, Ph meter, Balance, and Pipettes for accurate and reliable results. - Archiving relevant data following Standard Operating Procedures (SOP) in collaboration with the Quality Control (QC) associate to ensure data integrity and traceability. If you have a Bachelor's degree in Pharmacy (B.Pharm) or Life Sciences (B.Sc.) and possess 0-6 years of relevant experience, this role offers you an opportunity to contribute to the advancement of bioanalytical research with a focus on sample management and laboratory operations.,
As a Clinical Trial Assistant, you will be required to have 2-3 years of relevant experience in the field. A Bachelor's Degree in Life Sciences is the preferred qualification for this role. Your primary responsibilities will include working in an office environment to support the team during their absence as part of Clinical Trial operations. Your role will involve providing assistance and contributing to the efficient functioning of the team. If you have a keen interest in Clinical Trials and possess the necessary experience and qualifications, we encourage you to apply for this position.,
As a Sr. Drug Safety Associate in the Pharmacovigilance Call Center team at Jeevan Scientific, you will be responsible for leveraging your 3 to 5 years of experience in drug safety to ensure the safety and well-being of patients. Based in Hyderabad, you will play a crucial role in monitoring and reporting adverse drug reactions, providing accurate information to healthcare professionals and patients, and contributing to the overall drug safety process. Your primary focus will be on efficiently handling pharmacovigilance activities, including receiving and documenting safety reports, assessing their validity, and liaising with internal and external stakeholders to ensure compliance with regulatory requirements. Your attention to detail and strong communication skills will be essential in maintaining accurate and up-to-date safety data records. By joining our team, you will have the opportunity to make a meaningful impact on public health by contributing to the safe and effective use of pharmaceutical products. If you are a dedicated professional with a passion for drug safety and a commitment to quality and compliance, we invite you to apply and be a part of our dynamic and innovative organization. For further details or to apply for this position, please send your resume to Hr@jeevanscientific.com.,
Role Overview: As a Regulatory Medical Writer-Clinical trials (RMW-CT), you will be responsible for providing regulatory affairs (RA) strategic document expertise and support to one or more therapeutic areas (TAs) designated by leadership. Your role will involve supporting the preparation and submission of critical RA documents and responses to health authority (HA) or sponsor information requests. You will be the lead contact for sponsor or designated HA interactions with cross-functional teams, ensuring the accuracy and quality of submission-ready documents. Key Responsibilities: - Serve as the regulatory lead representative on project teams, partnering with outsourcing and operational teams to prepare high-quality documents such as Clinical Study Reports, Clinical Summaries, and Protocol Summaries for submission. - Understand Clinical Trial Protocol elements, coordinate review meetings, resolve document content issues independently, and prepare scientific communications for external publication. - Provide leadership and project management expertise, ensure accurate and timely completion of regulatory submissions, and communicate progress to leadership regularly. - Mentor and provide guidance to support staff, identify and implement process improvements, and assess resource needs as timelines progress. Qualifications Required: - Bachelor of Science in life sciences with significant relevant writing experience. - Advanced degree (e.g., MS Pharmacy, PharmD, PhD, MD) preferred, with a certificate in regulatory affairs and/or medical writing highly preferred. - 2-4 years of relevant industry experience in medical/regulatory writing required, with a good understanding of clinical development processes and guidelines. - High-level content writing experience, excellent written and oral communication skills, attention to detail, and peer-review/editing skills are beneficial. - Knowledge of Common Technical Document (CTD) content templates, electronic document management systems, and software programs like MS Word/PowerPoint/Excel is necessary.,