12 Protocol Preparation Jobs

You will be joining Horizon Biolabs Pvt Ltd., a GLP compliant Pharmaceutical Testing Laboratory in Hyderabad, India. As a candidate with an MSc in Microbiology and a minimum of 5 years of experience in a reputed Pharma Testing Lab/CRO/Pharmaceutical Industry, you will play a crucial role in the microbiological activities of the laboratory. **Key Responsibilities:** - Oversee and manage all microbiological activities, including testing, analysis, and research. - Supervise and lead a team of microbiologists, providing guidance, training, and evaluation for optimal performance. - Review and interpret test results, prepare reports, and communicate findings to relevant stakeholders. - Identify an...

Role Overview: You will be responsible for performing chemical and instrumentation analysis on various materials, including in-process, raw materials, packing materials, intermediates, and finished products. Your primary goal will be to ensure compliance with dispatch timelines as per the monthly schedule provided by PPL. Key Responsibilities: - Conduct instrumentation analysis using ICP-MS and LC-MS for various materials to meet dispatch timelines - Participate in analytical method developments, validations, transfers, and verifications using ICP-MS and LC-MS/MS - Prepare and review protocols, worksheets, and reports for method developments, validations, verifications, and transfers - Allot...

Role Overview: As a candidate for this position, your key responsibility will be to perform and analyze in vitro and in vivo DMPK studies to support drug discovery and development projects. You will play a crucial role in planning, designing, and setting up DMPK experiments, handling instruments, maintaining the laboratory, and preparing and reviewing protocols. Additionally, you will be in charge of writing reports, communicating with the project team, and presenting DMPK data in project meetings. Key Responsibilities: - Set up and perform physiochemical assays such as solubility and logP - Conduct in vitro DMPK assays including microsomal and hepatocyte stability, plasma stability, CYP inh...

As a Production Operator in the Plant, your role involves performing production activities in shifts. You will be responsible for operating process sequences through computer systems / HMI and communicating effectively with supporting departments such as QA, QC, warehouse, Engineering, and safety. Your coordination with DCS operators is crucial for the smooth functioning of operations. Key Responsibilities: - Perform activities as per Standard Operating Procedures (SOPs). - Fill Batch Production and Usage log book online. - Carry out all production activities in compliance with current Good Manufacturing Practices (cGMP) norms. - Prepare SOPs, Master Production Batch Records (MPBR) / Batch P...

Manager, Validation Quality Assurance | API Manufacturing Description : Manager Validation QA is responsible for overseeing, planning, and reviewing all validation activities, including equipment qualification, system validation, process validation, and cleaning validation, in compliance with regulatory and internal quality standards. This role ensures that all manufacturing and utility systems are validated and remain in a state of control, through risk-based approaches, robust documentation, and timely review of protocols and reports. The position requires expertise in current regulatory requirements and the ability to lead audits, investigations, and quality improvement initiatives. Essen...

As a Manager at Velocity Clinical Research, you will play a crucial role in study start-up activities, focusing on regulatory compliance, source document delivery, and ensuring timely submission of key documents to facilitate study initiation. Your responsibilities will include managing a team of regulatory specialists, proactively addressing regulatory challenges, driving efficiency, and ensuring that regulatory submissions are completed promptly to avoid delays in study start-up. You will be involved in preparing study-specific protocol documents, informed consent forms, HIPAA authorizations, and other necessary materials for review by the Institutional Review Board (IRB). Additionally, yo...

You are invited to join Horizon Biolabs Pvt Ltd., a GLP compliant Pharmaceutical Testing Laboratory based in Hyderabad, India. We are a global leader in providing laboratory testing services in Chemical and Microbiological segments for the pharmaceutical, biotech, and medical devices industries. We are looking for candidates with an MSc in Microbiology and a minimum of 6 months to 1 year of experience in a reputed Pharma Testing Lab, CRO, or Pharmaceutical Industry. Your responsibilities will include conducting Microbial enumeration tests, Antimicrobial Effectiveness Test (AET/PET), Sterility, Bacterial Endotoxin Test (BET by Gel Clot), Environmental Monitoring, Microbiological Assays, and W...

As a Research Scientist1 DMPK at the Foundation for Neglected Disease Research in Bengaluru, you will play a crucial role in supporting drug discovery and development projects by performing and analyzing in vitro and in vivo DMPK studies. Your responsibilities will include planning, designing, and executing DMPK experiments, maintaining laboratory instruments, and preparing protocols. Additionally, you will be tasked with writing reports, communicating with the project team, and presenting DMPK data during project meetings. Your technical skills will be put to the test as you set up and conduct physiochemical assays, in vitro DMPK assays, and bioanalytical methods. Your experience in analyzi...

The key responsibility of the candidate will be to perform and analyze in vitro and in vivo DMPK studies to support drug discovery and development projects. You will be involved in planning, designing, and setting up DMPK experiments, handling instruments, maintaining the laboratory, and preparing and reviewing protocols. Furthermore, you will be responsible for writing reports, communicating with the project team, and presenting DMPK data in project meetings. Required technical skills include the ability to set up and perform physiochemical assays such as solubility and logP, experience in conducting in vitro DMPK assays (microsomal and hepatocyte stability, plasma stability, CYP inhibition...

Role & responsibilities Job Responsibilities/Descriptions Primary Responsibilities: 1. To ensure shop floor compliance of Visual Inspection, Packaging, warehouse and Dispatch operations as per cGMP and cGWP requirements (IPQA activities). To prepare and review SOPs, study protocols, SPRs, TPRs pertaining to Fill finish, warehouse and quality assurance as required. 3. To Support in visual inspection qualification kits and visual inspection operator qualifications. 4. To review the trends of visual inspection results. 5. To support the Validation Team during the qualification activities at the area. 6. To provide Line Clearance for Visual Inspection, Packaging, Dispensing and Dispatch operatio...

Excellent opening for Process Validation role in Quality Assurance in Unison Pharmaceuticals, Moraiya Company: Unison Pharmaceuticals Website: www.unisonpharmaceuticals.com Department: Quality Assurance Location: Unit III, Moraiya, Ahmedabad Designation : Process Validation: Executive/Sr. Executive Experience: 3-9 Years (In PV) Qualification: B.Pharm/M.Sc Job Description : Prepare process validation protocol and send for review, approval and authorization to concern team members Facilitate process validation training to production, QC and IPQA Collect samples from Granulation, Compression / Capsule filling and Coating stages and send to QC for analysis Perform required documentation activiti...

Role & responsibilities Preparation and maintenance of training records To prepare specification and method of analysis as per requirement Preparation of protocols and reports Change Control, Analyst Qualification To support lab activities including analysis for method development and validation activities To ensure compilation and maintenance of logbooks for analysis done by HPLC Maintenance of records (user account, service records, sample request of samples) Ard Interested one can share updated resume on Whatsapp at 9915095113 or email at manik.mehta@scllifesciences.com