Novo Oriente Science Technology Job Listings

Pharmaceutical Process Consultant (Solid Dosage Forms)64962103763841120

Indeed

Pharmaceutical Process Consultant (Solid Dosage Forms)

**Your mission will be:** ---------------------- This position is part of the MSAT (Manufacturing Sciences and Technology) team, responsible for ensuring process robustness throughout the entire product lifecycle of chewable tablet technology. **Roles and Responsibilities:** ------------------------------- * Technically support the analysts’ team; * Act as LMSO (Local Matter Subject Owner) for assigned technology processes, recommending technical options during development and supporting the product lifecycle. Must have autonomy in making technical decisions; * Responsible for evaluating process data, identifying opportunities, and implementing improvements to pharmaceutical manufacturing processes, with the objectives of: reducing process losses, decreasing the number of deviations, increasing process robustness and reliability; reducing industrial, regulatory, and recall risks; * Lead improvement projects implementation at the Paulinia manufacturing site for the assigned technology; * Support maintenance of Product Control Strategies (CSS) and propose studies to support robustness of critical process parameters and critical quality attributes; * Lead Scale Down / Quality By Design projects for the assigned technology; * Deliver project progress report presentations; * Collaborate with Global/Local teams to implement parallel projects, ensuring sustainability of products using the assigned technology at the PLN site; * Collect and analyze process data using statistical tools and base decisions on data; * Implement projects defined by the MSAT area for the assigned technology; * Reduce industrial risks, conduct process risk analyses, and proactively propose improvements to process robustness, reliability, and safety; * Respond to regulatory audits such as MAPA, FDA, ANSES. **And what do you need to fulfill your mission? (Requirements)** ------------------------------------------------------------------ **Required:** --------------- * Bachelor’s degree in Pharmacy, Chemical Engineering, Food Engineering, Production Engineering, Materials Engineering, or related fields; * Experience in Solid / Chewable dosage form development; * Strong knowledge of industrial processes; * Extensive experience in manufacturing/packaging of solid / chewable products; * Extensive experience in food R&D or pharmaceutical R&D for solid dosage forms; * Advanced level of English. **Desirable:** * Experience working in companies regulated by FDA, ANSES, and MAPA; * Green Belt or Black Belt certification (a plus); * Postgraduate degree in Industrial Process Management, Engineering, Pharmacy, or Project Management.

GWX2+X2 Alívio, São Miguel do Tapuio - PI, Brazil

Laboratory Analyst - Temporary for 1 year64390995720578121

Indeed

Laboratory Analyst - Temporary for 1 year

**Your mission will be:** ---------------------- Carry out the execution and interpretation of physicochemical analyses, ensuring consistent analytical data generation and compliance with applicable regulatory and operational standards. Support continuous improvement of analytical processes and collaborate with partner areas, ensuring alignment with data integrity principles, safety, and good laboratory practices. **Roles and Responsibilities:** ------------------------------- * Manage area KPIs and support digitization projects (Power BI, Power Apps) and integration with systems (SAP, LIMS); * Perform physicochemical analyses and product inspections, ensuring quality, safety, and compliance with GMP/GLP standards; * Prepare, review, and maintain technical documentation (protocols, reports, MBRs) and manage analytical records in accordance with ALCOA\+; * Investigate deviations, events, and OOX, propose corrective/preventive actions, and lead continuous improvements; * Conduct process and method validations, analytical transfers, and equipment management according to the validation master plan; * Train and develop the analytical team, ensuring adherence to procedures and service to internal customers; * Participate in audits, technical forums, and strategic projects, ensuring data integrity and regulatory requirements. **Requirements:** --------------- * Experience with computerized systems applied to laboratories, such as: SAP, LIMS, LABX, EMPOWER, OPENLAB, TIAMO); * Completed bachelor's degree in Pharmacy, Chemistry, Biology, Biochemistry, or Chemical Engineering; * Experience with basic and instrumental physicochemical analyses (analytical techniques, fundamentals, and execution); * Knowledge of Good Laboratory Practices (GLP): proper use of PPE, organization, and cleanliness of the work area; * Familiarity with Data Integrity principles and ALCOA\+, including good documentation practices; * Knowledge of quality tools (Ishikawa, 5W2H, FMEA, Lean, Risk Analysis, FAR, URS, Change Control, CAPA, Deviations, Events, Training, SOP); * Knowledge of process and cleaning validation, sampling, and quality control; * Intermediate level of English.

GWX2+X2 Alívio, São Miguel do Tapuio - PI, Brazil

Indeed

Laboratory Analyst PL

**Your mission will be:** ---------------------- Assist in quality control performance indicators. Assist in identifying and addressing improvements within Quality Control (Lean Manufacturing vision). Develop and support automation/digitization tools for CQ processes, such as: Excel, Power BI, Power Apps. Assist in software projects related to Quality Control. For SAP\-QM, manage and migrate master data, enter certificate of analysis information into the SAP system, and migrate data from other sources into SAP. **Roles and Responsibilities:** ------------------------------- * Follow described work procedures/instructions to achieve quality and safety results in the Quality Control area at the Paulínia site; * Reassess medium to high complexity Physico\-Chemical analyses processes for raw materials, process samples, intermediate and finished routine products (release); * Stability, Validation protocols and test requests, reporting analytical data according to ALCOA\+, meeting the analysis schedule, to identify potential improvements; * Evaluate data generated through analyses, compile data and results, and detect possible trends; * Assist/contribute/execute the preparation/review of documents (procedures, forms, etc.) consistent with the activities of the Physico\-Chemical Quality Control Laboratory; * Assist in monitoring and controlling performance indicators; * Assist in developing tools to monitor/control CQ operational and performance indicators (e.g.: Power BI, Power App); * Collaborate with training new employees, ensuring adherence to current procedures; * Collaborate/execute investigation of analytical failures, Events, Discrepancies; * Execute implementation of Preventive/Corrective actions identified in Discrepancies/Events/OOX, Internal or External audits; * Participate/execute projects aligned with analytical activities under your responsibility (analytical job); * Participate in Housekeeping activities; * Attend to internal customers at the site; * Ensure compliance with EHS requirements; * Ensure compliance with data integrity requirements \- Data Integrity/ALCOA\+. **Requirements:** --------------- * Intermediate knowledge of Excel and Power BI; * Knowledge in analytical planning; * Knowledge in Quality Control activities (physico\-chemical and/or microbiological); * Knowledge of Good Manufacturing Practices. **Desirable:** -------------- * Extensive knowledge of Computerized Systems (e.g.: SAP, LIMS, LABX, EMPOWER, OPENLAB, TIAMO); * Strong writing, communication, and logical reasoning skills; * Knowledge of Lean manufacturing/six sigma.

GWX2+X2 Alívio, São Miguel do Tapuio - PI, Brazil

Laboratory Analyst (Temporary Contract)63826065061377123

Indeed

Laboratory Analyst (Temporary Contract)

**Your mission will be:** ---------------------- Assist in the performance indicators of Quality Control. Assist in identifying and addressing improvements within Quality Control (Lean Manufacturing perspective). Develop and support tools for process automation/digitization in QC, such as: Excel, Power BI, Power Apps. Assist in software projects related to Quality Control. For SAP\-QM, manage and migrate master data, enter analysis certificate information into the SAP system, and migrate data from other sources to SAP. **Roles and Responsibilities:** ------------------------------- * Follow described work procedures/instructions to achieve quality and safety results in the Quality Control department at the Paulínia site; * Reassess Physicochemical analysis processes of medium to high complexity in raw materials, process samples, intermediate and finished routine products (release); * Stability, Validation protocols and test requests, reporting analytical data according to ALCOA\+, meeting the analysis schedule, to identify potential improvements; * Evaluate data generated through analyses, compile data and results, and detect possible trends; * Assist/contribute/excecute the preparation/review of documents (procedures, forms, etc.) consistent with the activities of the Physicochemical Quality Control Laboratory; * Assist in monitoring and controlling performance indicators; * Assist in developing tools to monitor/control operational and performance indicators of QC (e.g., Power BI, Power App); * Collaborate in training new employees, ensuring adherence to current procedures; * Collaborate/excecute investigations of analytical failures, Events, Discrepancies; * Excecute implementation of Preventive/Corrective actions identified in Discrepancies/Events/OOX, Internal or External audits; * Participate/excecute projects aligned with analytical activities under your responsibility (analytical job); * Participate in Housekeeping activities; * Attend to internal clients at the site; * Ensure compliance with EHS requirements; * Ensure compliance with data integrity requirements \- Data Integrity/ALCOA\+. **Required:** --------------- * Intermediate knowledge in Excel and Power BI; * Knowledge in analytical planning; * Experience in Quality Control activities (physico\-chemical and/or microbiological); * Knowledge in Good Manufacturing Practices. **Desirable:** -------------- * Extensive knowledge in Computerized Systems (e.g.: SAP, LIMS, LABX, EMPOWER, OPENLAB, TIAMO); * Strong writing, communication and logical reasoning skills; * Knowledge in Lean manufacturing/six sigma.

GWX2+X2 Alívio, São Miguel do Tapuio - PI, Brazil