Sr Manager / Manager - Quality Assurance Curateq Biologics

15.0 - 17.0 years

20 - 35 Lacs

hyderabad

Work from Office

Role & responsibilities Suggested position: Sr Manager / Manager Education: Post Graduation (Life sciences preferred) Total Exp: 15-17 Years (Biopharma is preferred) Others: Ready to support in different shifts Responsibilities: Mainly responsible to review of Harvest, Drug Substance and Drug Product analytical (Biosimilars) raw data and analytical trends Conduct Gemba walkthroughs in QC department and to ensure quality compliance. Involve in investigations (Deviations, OOS, OOT, Lab incidents) to ensure QMS compliance for QC sections Audit trails and conduct routine monitoring in QC to check effectiveness of the system implemented. Responsible for preparation and review of documents SOPs, Protocols, Reports, Trends, APQR, Annual trends etc Track Reference standards related studies and review of related documentation timely

Posted 4 hours ago

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Production Engineer Craste

3.0 - 7.0 years

0 Lacs

morena, madhya pradesh

On-site

As a Production Engineer at Craste, you will play a crucial role in managing plant operations, ensuring top-notch output quality, and maintaining efficient processes. Your responsibilities will encompass various areas such as production, maintenance, quality control, and process enhancement. You will be actively involved in planning and executing daily production schedules to meet targets, troubleshooting and maintaining production equipment to minimize downtime, and managing Bill of Materials (BOM) along with unit cost analysis to ensure compliance with quality control standards. Coordination with procurement, logistics, and inventory teams will be essential, and experience with Odoo ERP system is preferred. Additionally, overseeing machine trials, installations, and commissioning of new equipment, driving process improvements for productivity enhancement and cost reduction, and being prepared to travel to sites when necessary to support operations are key aspects of this role. The ideal candidate for this position should hold a Bachelors degree or Diploma in Mechanical, Production, Industrial, Manufacturing Engineering, or a related field. Proven expertise in production, maintenance, and cross-functional coordination is required, along with a strong understanding of machinery, troubleshooting techniques, and cost analysis. Familiarity with ERP systems, especially Odoo, is beneficial, and exceptional problem-solving and communication skills are essential for success in this role. In return, Craste offers a competitive salary commensurate with your skills and experience, exposure to cutting-edge manufacturing processes and technologies, and the opportunity to directly contribute to the growth of a dynamic company. Join us in our mission to transform agricultural waste into valuable products and drive sustainability in various industries.,

Posted 1 month ago

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Manager (Quality Control) Piramal Pharma Limited

13.0 - 17.0 years

12 - 15 Lacs

Hyderabad, Zahirabad

Work from Office

Actively involve during LIMS deployment, act as LIMS admin, aware about CSV LIMS data management, Mater data creator and static maintainer for LIMS. Shall perform assessment, and supporting to investigations, deviations and implementing CAPA effectively. Overall responsible for Internal & External vendor follow ups and completions within the timelines. Responsible to procure and maintain the minimum stock for working standards, reference standards, impurity standards, chemicals, reagents, glass wares and solvents required for analysis and ordering as and when required Responsible to complete the work assigned and ensure the training on the activity which are assigned by supervisor/ HOD-QC prior execution. Responsible for completing assigned tasks and ensuring training on activities as assigned by the supervisor/HOD-QC prior to execution. Review of packing materials, raw materials, stability samples, in-process data, and finished product data. Review qualification, validation, calibration data, procedures, and audit trails in a timely manner. Identify unsafe conditions or acts in the laboratory, report them to the supervisor/HOD-QC, and ensure appropriate action is taken to address them. Receive and inward analysis samples, including packing materials, raw materials, in-process samples, intermediates, APIs, finished products, and stability samples, and log entries in the respective AR number logs. Allocate tasks for chemical and instrumentation areas, ensuring timely completion. Ensure assigned tasks align with analyst qualification reports. Review QC logs, incident reports, and other records, ensuring proper document archiving after the release of samples. Oversee control sample inspection and ensure the proper disposal of leftover samples after analysis. Ensure instrument calibration and AMC are completed as per the schedule. Prepare and revise SOPs, specifications, and procedures in line with regulatory requirements. Conduct training on SOPs, trending, and other relevant procedures. Prepare stability schedules, stability protocols, and reports, as well as validation/qualification and trending reports. Participate in investigations and ensure the effectiveness of CAPAs. Perform SAP activities and ensure QMS closure before batch releases in SAP. Actively participate during LIMS deployment, act as LIMS admin, and manage LIMS data. This includes master data creation and static maintenance. Conduct assessments, support investigations and deviations, and implement CAPAs effectively.

Posted 2 months ago

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