Leben Life Sciences is a biotechnology company focused on innovative solutions in drug discovery and healthcare.
Akola
INR 2.0 - 5.0 Lacs P.A.
Work from Office
Full Time
Designer Qualification: Any Graduate / Post Graduate Roles & Responsibilities: Export inquiry handling. Export follow ups. Point of contact for export consignment coordination with other department. Communicate order stutus delivery. MIS reports from ERP. Trademark software use.
Akola
INR 3.5 - 7.0 Lacs P.A.
Work from Office
Full Time
Role & responsibilities Responsible for following activities: a. Verify cGMP, GDP, GLP and data integrity practices, compliance in Quality Control and microbiology laboratory. b. Review of Specification, Standard test procedures and test data sheet for adequacy and accuracy. c. Review Validation and calibrations of all Instruments. d. Review of AMV, AMT Protocols and reports. e. Handling of Lab incidents, Deviations, OOS, OOC, OOT etc. f. Handling of reserved sample of finished products and its visual inspection. g. Review of trend data of environmental monitoring, water analysis. h. Participation in audit the contract testing laboratory. Preferred candidate profile ERP/ QMS/QC software system handling experience
Akola
INR 10.0 - 12.0 Lacs P.A.
Work from Office
Full Time
Role & responsibilities : a. Plan, manage, and oversee the work activities of QC and Microbiology laboratories to ensure lab testing provides the highest quality analytical support for manufacturing in a timely and compliant manner, adhering to protocols, cGLP, and safety regulations. b. Manage analytical method validation of products, method transfer, stability studies, and related activities to ensure compliance with regulatory and quality standards c. Provide leadership, management, performance evaluation, and training to all laboratory employees to maintain a competent and motivated team. d. Execute and approve all laboratory operations, including reviewing and investigating any laboratory data that is outside of established trends. e. Ensure all vendors are qualified and comply with vendor qualification standards, aiming for optimal utilization of reduced testing procedures. f. Establish and implement a KPI system to ensure an optimal balance between test quality and cost efficiency. g. Collaborate closely with other departments to ensure the plant's compliance with the Quality Management System (QMS). Preferred candidate profile Candidates having experiences in Pharma formulation(OSD) of EU/USFDA plant are preferred
Akola
INR 2.75 - 5.0 Lacs P.A.
Work from Office
Full Time
Role & responsibilities 1. Prepare, compile, and review regulatory dossiers for submission. 2. Respond to queries and deficiency letters from regulatory authorities in coordination with technical teams. 3. Co-ordinating with cross-functional teams like R&D, QA/QC, production to collection of data for submissions. 4. Maintain regulatory files and track submission and approval status using internal systems. 5. Provide regulatory input during product development, scale-up, and lifecycle management. 6. Supporting the review of product labels, cartons, and inserts to ensure compliance with regulations. 7. Ensure products comply with all regulatory requirements through each stage of development and commercialization. 8. Conduct training sessions on regulatory updates and internal System 9. Ensure documentation is audit-ready and aligned with internal SOPs and regulatory expectations. 10. Support internal and external audits by providing required regulatory documents and justifications. 11. Guide and review work of junior team members or trainees. 12. Review and interpret regulatory guidelines and notify stakeholders of relevant updates. 13. Review of all dossiers related technical documents Preferred candidate profile Experience in reviewing of Analytical documents
akola, maharashtra
INR Not disclosed
On-site
Full Time
The Process Coordinator in the Admin Department plays a crucial role in ensuring the alignment and efficiency of processes and workflows. You will be responsible for utilizing your Excel skills to track processes, make entries, and generate reports. It will also be your duty to maintain documentation, records, and files, ensuring that both hard and soft copies are properly updated. In case of workflow issues or bottlenecks, you are expected to identify and escalate these to the management for resolution. Collaboration with other departments is essential for the smooth functioning of related work. This is a full-time position that offers benefits such as life insurance and provident fund. The work schedule is during the day shift, and there is a yearly bonus provided. The ideal candidate should have at least 1 year of total work experience. The work location is in person. If you are interested in this role, please contact the employer at +91 7498035480 for further discussions.,
Akola
INR 2.0 - 3.0 Lacs P.A.
Work from Office
Full Time
Role & responsibilities : 1) Having from OSD background. 2) Responsible for analysis of RM/IP/FG/Stability on HPLC. 3) Responsible for Calibration of HPLC 4)Having the Knowledge of the Pharmacopeia.IP/BP/Ph.Eur/USP Skill Required: 1) Handling of the HPLC, 2) Calibration Management. 3)Knowledge of the GLP Environment 4) Handling of the HPLC, 5) Calibration Management. 6)Working Standard, Ref. Standard, Imp Standard, Primary Standard Management Additional Remark: Required candidates background should be in Regulatory environments
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