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Analytical Development Chemist
Negotiable Salary
Indeed
Full-time
Onsite
No experience limit
No degree limit
Baja California, Mexico
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Description

• Review bibliographic information to support the development, verification, validation and/or revalidation of analytical methods. * Review, update and issue documents related to analytical developments (Protocols, Reports, Verifications, Validations and/or analytical revalidations, among others). * Perform validations, verifications and/or revalidations of the analytical methods required to evaluate the quality of active ingredients, additives and products at different stages. * Conduct physicochemical analyses of active ingredients, additives and products at different stages or any required analysis for products under development. * Prepare and issue documents related to analytical development (Specifications, Analytical Methodologies, among others). * Detect and report any incidents related to analytical development or performed analyses. * Comply with good documentation practices and data integrity. * Know and operate laboratory equipment and instruments in accordance with good laboratory practices. * Comply with Standard Operating Procedures related to analytical development and those corresponding to the Quality Control laboratory. * Develop and monitor the Quality Management System related to analytical development (Risk Analysis, Change Controls, RAFE, CAPA, among others). * Support general activities required by the area to achieve objectives. * Respect and enforce Good Laboratory Practices Number of vacancies: 2 Work modality: On-site **Social or economic benefits** Airfare Accommodation for 90 days " **Requirements** KNOWLEDGE Intermediate-Advanced in: * Analytical Chemistry (General, Quantitative and Qualitative) * Instrumental Chemistry (HPLC, GC, UV-VIS and IR spectrophotometer, Dissolution Tester, TOC, Balances, potentiometer, Karl Fischer titrator, climatic chambers, among others) * Intermediate/Advanced Statistics (descriptive and inferential) * Good Laboratory Practices * Good Manufacturing Practices * Good Documentation Practices * Handling of national and international pharmacopoeias (FEUM, USP, EP, BP, among others). * Preparation and issuance of documents inherent to their activities (Specifications, Analytical Methodologies, Protocols, Reports, Reports, Verifications, Validations and/or analytical revalidations, among others). * Risk Management System * Analytical Method Validation. * Analytical method transfer * Office software * NOM-059-SSA1-current * NOM-073-SSA1-current * NOM-177-SSA1-current * National and international analytical method validation guidelines * National and international regulatory documents related to the pharmaceutical industry. * Technical English (reading-writing). Minimum education level Bachelor's degree Minimum experience 1 year Willingness to travel None

Source:  indeed View original post
Juan García
Indeed · HR

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