117 Ich Guidelines Jobs - Page 5

Key Responsibilities: Establish, implement, and maintain GMP-compliant quality systems across the API manufacturing unit. Lead and participate in regulatory, internal, and third-party audits ; ensure timely closure of observations and CAPAs. Review and approve validation protocols, master documents, and batch records in line with regulatory requirements. Oversee product release , stability studies, and quality documentation control. Manage and investigate market complaints and implement appropriate corrective actions. Ensure regulatory compliance with international guidelines (e.g., USFDA, EU-GMP, WHO-GMP). Handle vendor audits and qualification for raw materials, packaging materials, and th...

The Associate Medical Reviewer position at Novo Nordisk Global Business Solutions (GBS) India, specifically in the Centralised Monitoring Unit (CMU) department in Bangalore, Karnataka, IN, offers a challenging and dynamic environment for individuals who are motivated by working closely with key stakeholders and strive for continuous improvement in their career objectives. As an Associate Medical Reviewer, you will play a crucial role in conducting comprehensive medical reviews of clinical trial data across various therapy areas within the drug development portfolio. Your responsibilities will include ensuring the highest quality and consistency of medical data, with a strong emphasis on pati...

You will be joining our ARD team in Udaipur as an ARD Chemist / Scientist. Your main responsibilities will include method development and validation, impurity profiling, and instrumental analysis to assist our Synthesis R&D and quality operations. Your key responsibilities will include developing HPLC, GC, and LC-MS analytical methods for monitoring in-process reaction samples, validating HPLC methods suitable for AMV, performing impurity profiling of APIs and intermediates, identifying and characterizing impurities using advanced techniques like mass spectrometry, ensuring all analytical instruments are well-maintained, performing regular calibration and documentation of analytical instrume...

As an ARD Chemist / Scientist at our Udaipur location, you will be a key member of our ARD team, responsible for method development and validation, impurity profiling, and instrumental analysis to support our Synthesis R&D and quality operations. Your primary responsibilities will include developing and validating HPLC, GC, and LC-MS analytical methods for monitoring in-process reaction samples, as well as developing HPLC methods suitable for Analytical Method Validation (AMV) and transfer to QC. You will also be tasked with performing impurity profiling of APIs and intermediates, identifying and characterizing impurities using advanced techniques like mass spectrometry, and ensuring that al...

As a Safety & PV Specialist I-Japanese at Syneos Health in Pune Office, your primary responsibility will be to ensure accurate and timely processing of Individual Case Safety Reports (ICSRs) in compliance with Standard Operating Procedures (SOPs) and regulatory requirements. You will play a crucial role in maintaining safety tracking, performing data entry into safety databases, coding events and medical history, and compiling narrative summaries. Additionally, you will be involved in the validation and submission of xEVMPD product records, management of duplicate ICSRs, and activities related to SPOR / IDMP. Your role will also include conducting literature screening and review for safety, ...

Job Title: GLP-Quality Assurance Personnel Location: Bangalore, KA, IN, 560099 Syngene International Limited, Bengaluru is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is a top priority, with a focus on ensuring safety guidelines, procedures, and SOPs are followed diligently. As a GLP-Quality Assurance Personnel at Syngene, you will play a crucial role in aligning laboratory practices with Good Laboratory Practice (GLP) guidelines to maintain the integrity and reliability of non-clinical safety and clinical studies. You will also work in a regulatory envir...

Assist with data management leadership on a large/global project or multiple projects with responsibility for Thesaurus Management and technical oversight of all dictionary coding activities for the delivery of medical coded data according to Fortrea/client quality and integrity specifications, project timelines, and budgets. Develop and maintain a close liaison with project Lead Data Reviewer, core team members, and Clinical Lead Data Managers as appropriate. Perform the clinical medical data coding aspects of assigned projects on a global basis independently. Work with the Manager to aid in personal career development, interpersonal skills, and achievement of competency standards. Assist i...

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 findin...

Review Site Visit Reports (SVRs) to ensure they meet or exceed quality standards and support goals of quality, subject safety, data integrity and regulatory compliance. Use tools and techniques to ensure the efficient and effective review of Site Visit Reports and their associated attachments, in compliance with IQVIA SOP, ICH/ GCP guidelines, and protocol requirements Essential Functions Oversee a caseload of SVRs for assigned studies, ensuring compliance to the protocol, processes, timelines, IQVIA/applicable SOPs, and GCP guidelines. Review SVRs to ensure findings requiring corrective and /or preventative action plans are documented and followed up to resolution, to ensure high quality re...

We are seeking a meticulous and experienced Manager Quality Control to lead and enhance our quality control operations at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in overseeing all aspects of quality control, ensuring adherence to Good Laboratory Practices (GLP), and maintaining a robust Quality Management System (QMS). Your expertise will be crucial in driving Analytical Method Development, managing CAPA and Change Control processes, and upholding Data Integrity standards. You will lead a team of QC analysts, providing training and mentorship to foster a culture of excellence. The ideal candidate will possess a strong understanding of ICH Guidelines and ...

We are seeking a meticulous and experienced Executive/Sr. Executive to spearhead chromatographic analysis and data review at Synnat Pharma Private Limited, a rapidly growing API manufacturer. In this pivotal role, you will be responsible for ensuring the accuracy, reliability, and compliance of analytical data generated within our QC laboratory. Your expertise will be crucial in adhering to stringent regulatory standards, including ICH guidelines and pharmacopeial requirements, while contributing to the overall quality and integrity of our pharmaceutical products. The ideal candidate will possess a strong understanding of HPLC and GC systems, coupled with proficiency in Empower CDS and a dee...

We are looking for a meticulous Executive/Sr. Executive to spearhead regulatory submissions and review at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in ensuring our API manufacturing processes adhere to global pharmaceutical regulations. Your expertise will be essential in compiling, reviewing, and submitting comprehensive regulatory documentation to various health authorities, including the US FDA, EMA, and CDSCO. You will manage regulatory inspections, handle queries, and lead the preparation of DMF filings. The ideal candidate will possess a deep understanding of regulatory guidelines, ICH guidelines, and relevant pharmacopeias (USP, EP, BP), coupled wit...

Job description : Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports Demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or important safety issues Act as a technical lead of the medical writing teams across projects and provide guidance and expertise for developing high-quality scientific content as required for various safety deliverables Establish good client communication and coordination within writing teams to manage stakeholder expectations and resolve any issues surrounding project/report deliverables Contribute to scientific publ...

We are looking DM RA with leading pharma company in Thane. Experience in Injectable regulatory affairs pre approval & post approval experience is must. Regulatory Submissions New Project Assignment This role involves the assignment and management of new projects for regulatory submissions, playing a pivotal part in the preparation and timely submission of high-quality regulatory documents across the US, EU, UK, and Emerging Markets. The position demands a strong understanding of global regulatory requirements, excellent communication skills, and effective cross-functional collaboration to ensure successful outcomes. Educational Qualifications Bachelor’s or Master’s degree in Pharmacy, Chemis...

Elevate Your Career with us, we're Seeking Masterminds to Drive Excellence! Evolet Healthcare Pvt. Ltd. is hiring for the position of Sr./Executive- Drugs Regulatory Affairs. Job Description: Having experience in dossier compilation (CTD & ACTD) for CIS, ASEAN, LATAM and AFRICAN countries. Controlling the whole process of registration products from the beginning till the end. Evaluation of Bioequivalence and Clinical Trials (preferably). Required Candidate profile: Having knowledge of ICH guideline with relevant 1-5 years of experience. Having experience in registration any CIS, ASEAN, LATAM and AFRICAN countries. To be flexible for travelling and meeting with manufacturing plant representat...

Job Description We are looking for a dedicated and enthusiastic individual to join our Analytical Development team. The ideal candidate will contribute to maintaining high-quality standards in analytical research and support the development of safe and effective pharmaceutical products for global markets. This role offers hands-on experience in method development, validation, and regulatory documentation within a dynamic R&D environment. RESPONSIBILITY : Assisting to Team leaders, Research Scientists of Analytical Development departments on Research work and daily basis activity. Work towards Analytical development, Validation, Transfer activities of oral solids, Oral Liquids, Parenteral and...

We are looking for passionate and motivated individuals with an M. Pharmacy or PhD qualification to join our dynamic Research & Development team as a Research Associate (Formulation & Development). As a Research Associate, you will be actively involved in formulation development for various dosage forms, supporting scientists in innovative pharmaceutical research for both regulatory and ROW markets. Job Description: Assisting to Team leaders, Research Scientists of Formulation & Development on Research work and daily basis activity. Work towards formulation development of oral solids, Liquids, Parenteral and semisolid products for Regulatory & ROW markets. Conduct product development activit...