, Chronometer. Understanding of GxP, GMP process. Good exposure and understanding of IT infra like Anti-Virus, AD, Asset...
Job Description: The GMP Operational Quality Senior Specialist supports the principles and application of quality... assurance and regulatory compliance. The GMP Operational Quality Senior Specialists works with a high degree of independence...
Job Description: The GMP Operational Quality Specialist works with a high degree of independence to provide QA... Analytical support for release of commercial products. The GMP Operational Quality Specialist executes routine tasks...
Job Title: Engineer, GMP Drug Delivery Medical Device (JP13357C) Location: Cambridge, MA 02138 OR Thousand Oaks, Ca... and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development...
Associate Director, GMP Quality Assurance Who we are: is a biopharmaceutical company that is fueled by connections... you will make: Agios Pharmaceuticals is searching for a dynamic Associate Director to join our growing GMP Quality Assurance team...
Hello I'm Komal from Intellectt we have an opening for a Validation Engineer in Boston, MA. Please find the... job details and description below and if interested You can reach me at komal@intellectt.com or call me at +1(732)-813-9025. Role: Validation Engineer I Location...
, as necessary. Validation Documentation: Draft, review, and revise validation protocols, test plans, and reports, ensuring... alignment with regulatory standards. Maintain meticulous records of validation activities for audits and inspections. CQV...
Job Description The Associate Director, Process Validation, Manufacturing Science and Technology (MSAT) – Late-Stage.... Implement consistent process qualification, process validation and CPV strategies. Support the establishment of network...
, 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...
Work Schedule Second Shift (Afternoons) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP... requirements of the role. Knowledge, Skills and Abilities: Microbiology background is a plus GMP exp is a plus Performed...
Engineer Location: Boston, MA We are looking for a highly skilled Computer System Validation candidate with extensive... Commissioning, Qualification, and Validation experience in a pharmaceutical manufacturing facility. The individual for this position...
Work Schedule First Shift (Days) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety... requirements of the role. Knowledge, Skills and Abilities: Microbiology background is a plus GMP exp is a plus Performed...
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...
-to-end logistics coordination of temperature-controlled GMP and non-GMP pharmaceutical materials worldwide. Communicate... to ensure shipments are moved as efficiently and compliantly as possible. Partner with Quality and Shipping Validation teams...
for GMP product quality and compliance for product release; Provides QA support for development and commercial change... controls, GMP investigations, associated CAPAs and Effectiveness Checks; Reviews and approves manufacturing documents...
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...
all phases of development, process validation and commercialization to understand process requirements and provide feedback... during GMP manufacture Lead, write and review deviations and investigations for the Drug Product Facility, Facilities, Materials...
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety... such as method validation/verification and method transfer Be accountable for the success of ALCM projects/activities and ensure...
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety... for assay results. Establish reference standard materials as required to support assay validation. Establish a critical...
transfer and validation, impurities, mutagenic impurities, etc. Strong knowledge of GLP and GMP requirements... and their application in a phase appropriate manner Experience in technical transfer for non-GMP and GMP production and testing to external...