method validation, method transfer, method remediation, method investigation support, process and product development as well... and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities...
expertise in biological assay development, validation, transfer, and troubleshooting compliant with GMP operations of Bio-CGT...: Lead ALCM projects including late stage and post-marketing approve analytical activities such as method validation...
, all while maintaining full-time benefits. Key responsibilities: Work in a GMP laboratory performing method validations and transfers... sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Experience with GMP...
all activities under Good Manufacturing Practices (GMP) guidelines. The Quality Control Specialist is responsible for supporting... a variety of analytical functions that occur in the Quality Control (QC) department supporting validation, testing and reporting...
product release, complaint management, data management, calibration and validation requirements, conducting investigations..., management of Quality systems for deviations, change controls and CAPAs, validation and maintenance of equipment, quality support...
, method qualification/validation, verification, and implementation. By ensuring these critical activities are executed... standards (e.g., GMP, GLP, ICH guidelines) to maintain the highest levels of quality and compliance. Actively participate...
ACDM, DPT, AS, Quality, Regulatory and clinical supply) Extensive knowledge of GLP and GMP activities Understands the... technologies related to analytical technologies, mammalian and microbial cell culture, protein purification, automation, validation...
within Commercial Manufacturing & Supply Chain (CMSC) department. S/He/They will provide expertise in assay development and validation... development, validation, and method transfer Author and/or review technical documents, including method SOP, study protocol...
stakeholders by working with project teams and stakeholders to mitigate them during clinical development, validation, submission... governance teams covering Analytical Development, Process Development, Technical Operations, and Supply Chain topics for GMP/GDP...
Responsibilities: Issue, review, and approve GMP documentation (e.g., batch records, SOPs, job aids..., equipment qualification, and validation documentation for adequacy and compliance. Review batch record documentation, ensure...
their growth and development. Oversee the development and validation of core analytical methods, with a focus on chromatographic... techniques. Collaborate with project teams to design, oversee and review relevant analytical methods, validation protocols...
industries. The Eurofins BioPharma Product Testing (BPT) Group is the largest network of harmonized bio/pharmaceutical GMP... and all functional areas of bio/pharmaceutical manufacturing, including method development, microbiology, process validation and quality...
, validation, transfer, and troubleshooting compliant with GMP operations, supporting product development and/or commercialization... assay development, validation, transfer, and lifecycle management for late-stage and commercial applications. In addition...
within the QISM scope. Computer system validation, Data integrity, Medical device 510K, Predicate rules, ECTD,21 CFR Part 11..., 210, 211, 312, 314, 820 GXP,GMP, GDP, GLP, CAPA, Change control, Risk assessment, Data base, Trail master file, EPIC...
in biological assay development, validation, transfer, and troubleshooting compliant with GMP operations of Bio-CGT potency methods... development, validation, transfer, and lifecycle management for late-stage and commercial applications. Key responsibilities...
across three main areas: a) Characterization and in vitro comparability, b) Method development and validation of methods... testing applications). Knowledge of complex and state-of-the-art methodology for biologics GMP method development...
, etc.) and industry standards (GMP, GxP). Prepare and review validation documentation, including Validation Master Plans (VMP), User... Engineer will play a crucial role in ensuring the successful commissioning, qualification, and validation of facilities...