Role & responsibilities Support the DSCSA reconciliation process by assisting with daily and weekly reporting activities. Format, clean, and analyze Excel datasets containing shipment and serialization information. Interact with Level 4 (L4) vendor systems to perform basic data validation and processing tasks. Read, interpret, and manage XML files related to serialized pharmaceutical product data. Manage and track tickets raised with the L4 system using Salesforce ticketing platform. Collaborate with cross-functional teams to investigate and resolve data discrepancies promptly. Preferred candidate profile Candidate should have good experience in DSCSA Serialization , L4 System for US Market. Interested candidates may apply on Madhura.patil@rubicon.co.in
Role & responsibilities We are seeking an experienced and proactive Project Manager to lead the end-to-end execution of pharmaceutical development and commercialization projects, specifically for Solid Oral Dosage Forms and Liquid Orals . The selected candidate will manage cross-functional coordination from product development, technology transfer, regulatory filing to Approvals , ensuring all project milestones are delivered on time, within scope, and in full compliance with business and regulatory requirements. Skills and Competencies: Deep understanding of pharmaceutical product development, technology transfer & Familiarity with global regulatory frameworks and dossier submission processes Strong competency in project planning, risk management, and cross-functional leadership . Proficiency in Microsoft Project, Excel and PowerPoint for real-time project tracking and reporting. Excellent stakeholder management, communication, negotiation and leadership skills . Highly organized, proactive and solution-focused approach to project management. Key Attributes: Collaborative and team-oriented leadership style . Strong analytical thinking and problem-solving capabilities. Ability to perform effectively under tight deadlines in a regulatory-compliant environment . High degree of ownership, accountability, and customer-centric mindset . Key Responsibilities: Lead the planning, execution, and delivery of pharmaceutical projects encompassing Formulation Development, Analytical Development, Regulatory Filing, Manufacturing, and Supply Chain from initiation through Product Approval. Develop and maintain comprehensive project plans including timelines, milestones, resource allocation and risk mitigation strategies using standard project management tools. Coordinate cross-functional teams including R&D, Regulatory Affairs, Quality Assurance, Production, Supply Chain, and Business Development to ensure effective collaboration and timely execution. Manage technology transfer activities from R&D to manufacturing, ensuring robust scale-up, validation, and readiness for commercial production. Serve as the central communication point for internal teams and external partners, ensuring alignment on project goals, timelines, and deliverables. Ensure regulatory submission preparedness for assigned projects and provide active support during dossier filing and query resolution for designated markets. Identify potential risks, establish risk mitigation strategies , and ensure early resolution to maintain project timelines and objectives. Monitor project budgets and resource allocations to ensure optimal utilization, escalating deviations where necessary to maintain alignment with organizational goals. Organize and facilitate regular project review meetings ; prepare clear, data-driven status reports and dashboards for senior management. Ensure strict compliance with GMP, global regulatory guidelines (USFDA, EMA, WHO, MHRA, etc.) , and internal quality standards throughout the project Lifecycle Preferred candidate profile Candidate should have hands on experience in R&D Project Management, People management, Stakeholder Management etc. the incumbents' project management experience should be 5+ years. Interested candidates may apply on madhura.patil@rubicon.co.in Call me on 9892423060 to discuss more on this role.
Role & responsibilities To perform method development and validation for Extractable and Leachables, Nitrosamine and another specific impurity by LCMS (GCMS and ICPMS added advantage) To prepare analytical method validation protocols for various validation by ICP-MS, GC-MS and LC-MS To prepare Technology transfer Protocol and reports. Technology transfer of LCMS method (leachable content, NDSRI and Genotoxic Impurity). Responsible for calibration of analytical pH meter, Balance, ICP-MS, LCMS and GCMS instruments. Responsible for preparation AMDR, Validation Reports, E&L and NDSRI reports. Responsible for ensuring compliance with GLP, Safety and Environment requirements. Participate in training session . Participate effectively in investigations related to deviations/incidences and to suggest CAPA. Preferred candidate profile Candidate should have hands on experience in method development and validation for Extractable and Leachable by LCMS. The candidate should be willing to travel to Plant for method Transfer activities. Interested candidates may apply on madhura.patil@rubicon.co.in Call me on 9892423060 to discuss in details on the role.
Role & responsibilities The incumbent will responsible for of Alternate vendor development, Additional strength management, Site Transfer, and core product development. Responsible for formulation and process development of oral dosage forms, including oral solid and liquid formulations. Troubleshooting and problem-solving of unresolved or new formula issues. Design and execute formulation trials and evaluate stability data to finalize formulation composition. Develop manufacturing processes for R&D formulations so that the technical transfer is successful for large scale batches. Assist to alternate vendor development formulation activities along with product development of site transfer project. Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, QOS etc. Support the manufacturing of exhibit/submission batches per regulatory requirements. Support technology transfer for manufacturing processes from laboratory scale to production scale. Works with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control, etc. to expedite the development and approval of new products by FDA. Assure that all formulation and process development activities are documented in the notebook as per company procedures and cGMPs. Preferred candidate profile Candidate should have hands on experience in Formulation development for US Market. Interested candidates may apply on madhura.patil@rubicon.co.in. Call me at 9892423060 to discuss more on the role
Role & responsibilities To perform the Characterization, Reliability and IVBE Dissolution Study of Nasal products at Ambernath unit Should have hands-on experience in performing the dissolution, assay & RS tests. To perform the calibration of instruments like dissolution apparatus, UV spectrophotometer, HPLC and GC, Dissolution, Spraytec and spray view instruments. Experience in testing Spray pattern and Droplet size distribution will be an added advantage Follow the system / operational SOPs. Ensure data integrity and accuracy of data generated. Should have knowledge of ICH and regulatory guidelines. Collaborate with different departments as per the requirements Preferred candidate profile M. Pharm/M. Sc. Knowledge of handling instruments such as HPLC, GC, Dissolution, Spraytec , spray view instruments, UV spectrophotometer etc. . Exposure to Nasal/Ophthalmic/injectable / Liquid Oral dosage forms analysis. Interested candidate can share their resumes on -virender.thakur@rubicon.co.in
Role & responsibilities To perform physical and chemical, instrumental analysis of Raw Material, packaging material, Water samples, In Process, Finished Product Samples and Stability Samples. The candidate should have experience on HPLC, GC UV, IR and Dissolution testing. To perform a Release testing, Dissolution profile study, challenge study ,Hold time study, RLD sample analysis, validation, verification, method transfer activity and API-Verification as when applicable. To perform instrument calibration and working standard qualification. Responsible to adherence of GLP and Health, Safety Environment system in Laboratory. To perform the task assigned by the supervisor/HOD as and when required. Should have good written and communication skill. Preferred candidate profile Candidate should have hands on experience in Quality control of various dosage forms i.e OSD, Liquid orals etc. Interested candidates may apply on Priyanka.patil@rubicon.co.in
Role & responsibilities To perform microbial analysis of Raw Material, Water samples, In Process, Finished Product Samples and Stability Samples. To perform Media preparation, sterilization and Growth promotion testing. To perform hold times studies carried out in Microbiology department. To perform Preservative efficacy test. To perform Microbial Limit Test validation. Prepare Environment Monitoring and Water analysis Trend. Perform culture maintenance and purity of cultures.` To perform instrument calibration and qualification of Incubators, Autoclave. Responsible to adherence of GLP and Health, Safety Environment system in Laboratory. Should have good written and communication skill. Preferred candidate profile Candidate should have hands on experience in Microbiological activities for OSD, Liquid Orals etc. Interested candidates may apply on priyanka.patil@rubicon.co.in
Role & responsibilities To ensure cGMP Compliance as per laid down procedures. Monitoring overall all QA activities - Process validation, Cleaning Validation, Equipment Qualification and Master Document review. Preparation and review of SOPs applicable to QA. Evaluation of QMS documents. Preparation of Validation Master Plan, review of process validation, equipment qualification and cleaning validation protocols and reports Participate in investigations and review of investigations. Monitoring of Exhibit and Submission batches documentation and Coordination with RA for document submission Monitoring of document control, storage, and archival. To provide training to QA team members and other functions. Participate in customer and regulatory inspections and ensuring CAPA effectiveness. Participate in self-inspections. To audit the internal quality system as a part of self-inspection (internal audit). Timely and proactively escalating issues. Preferred candidate profile Candidate must have experience of shop floor working, in-process quality assurance, Process Validation, Cleaning Validation, Equipment Qualification and ability to handle the team. Preferably form Liquid Oral/ potent formulation/ OSD. Interested candidates may apply on priyanka.patil@rubicon.co.in
Role & responsibilities Responsible for formulation and process development of oral dosage forms, including oral solid and liquid formulations. Troubleshooting and problem-solving of unresolved or new formula issues. Design and execute formulation trials and evaluate stability data to finalize formulation composition. Develop manufacturing processes for R&D formulations so that the technical transfer is successful for large scale batches. Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, QOS etc. Support the manufacturing of exhibit/submission batches per regulatory requirements. Support technology transfer for manufacturing processes from laboratory scale to production scale. Works with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control, etc. to expedite the development and approval of new products by FDA. Assure that all formulation and process development activities are documented in the notebook as per company procedures and cGMPs. Preferred candidate profile Candidate should have hands on experience in Formulation development, Scale up, Exhibit batches, Documentation etc for OSD, Liquid Orals for US Market Interested candidates may apply on Madhura.patil@rubicon.co.in Call me on 9892423060 to discuss more on the role.
Role & responsibilities Line clearance certification during product changeover Proof checking of overprinted matter Review of batch manufacturing and batch packaging records Sampling of bulk finished and pack finished products Packline inspection and performing in-process checks Sampling of process validation, Hold time study. Monitoring of shopfloor activities through rounds, identification and notification of potential discrepancies Review of master batch documents, process flow and PVIA. Verification and authorization of EMRM and DPR. 2. Other activities Data logger placement and review of transit data. Review of Audit-trails of production equipment / instruments Placebo batch related activities. Review of artwork and related change controls Maintaining product data excels. Control and Monitor technology transfer activities. Preferred candidate profile Candidate should have hands on experience in IPQA Activities in OSD/Liquid/ nasal spray dosage forms. Interested candidates may share their applications on priyanka.patil@rubicon.co.in
Role & responsibilities 1 )Well versed in the analytical review of documents, which includes of those from GLP section, 2) OOS, OOT, Events, Change control, CAPA related QMS handling 3) Column management, Standard handling, glassware management, chemical management 4) Retention samples management and review of stability sample and study management. To review of stability protocol/summary sheet 5) Computer system validation, calibration & qualification of instruments. Review of audit trail from the computerized systems. 6) Ensure QC laboratory compliance at all times, participate in Lab check rounds. 7) Preparation & review of OOS/OOT/Events trending. 8) Review of analytical documents, chromatograms related to AMT/AMV protocols and reports. 9) Preparation of SOPs 10) To review the Analytical reports in support of Batch release activities 1) To review and approve the batches with generation of Certificate of Analysis for Finished Product 12) Review Analyst qualification data Preferred candidate profile Candidate should have hands on experience in Analytical QA, Lab QA Activities for OSD/Liquid Oral/ nasal dosage forms. Interested candidates may apply on priyanka.patil@rubicon.co.in
Role & responsibilities 1*Batch Manufacturing: Oversee batch production, including setup, operation, and cleaning of equipment of EB & commercial. 2.*Regulatory Compliance: * Ensure that all formulations comply with relevant regulatory requirements, including FDA and ICH guidelines. Familiarity with regulatory inspections and compliance. 3.*Innovation: * Drive innovation for new technologies and approaches to improve product performance. 4. *Project Management: * Manage multiple projects simultaneously, prioritizing tasks, allocating resources to meet project timelines and understanding associated safety protocols. 5.*Collaboration: * Collaborate with cross-functional teams, including analytical development, manufacturing, and quality assurance to ensure seamless product development. 6.*Documentation: * Ensure accurate and timely documentation of formulation development activities, including BMR, reports, protocols, Qualification, regulatory submissions, Deviation and OOS. 7. *Training and Development: * Train and develop junior staff members to ensure assessment, skill matrix, understand GMP regulations and manufacturing procedures. Preferred candidate profile Candidate should have hands on experience in Manufacturing of Liquid orals. Interested candidates may apply on priyanka.patil@rubicon.co.in
Role & responsibilities Coordination with the site project team and other functions such as quality, operations for design & execution of facilities and equipment Coordination with external vendors for civil, mechanical, electrical, instrumentation for execution activities as per design with safety, quality, statutory compliance and timelines QMS handling which includes SOP, schedules, calibrations and IQ, OQ, PQ validations, Change control & deviation handling. Coordination with vendor, Preparation of BOQ / techno commercial comparison chart, Raising Purchase request. Coordination with the Purchase department for releasing purchase orders. Follow up with vendors for material. Bill certification Coordination for statutory layouts and permissions such as Boiler, factory Inspector, Electrical Inspector , MPCB etc Project management includes preparation of Gantt Charts, monitoring the project as per Gantt chart, coordination with vendor and actual site work monitoring. Preferred candidate profile Should handle Civil , Mechanical , Electrical , HVAC execution with planning , Coordination with consultants ,vendors , Bill certification area & equipment qualification / validation, Material estimation as per design and coordination with procurement team.
To perform physical and chemical, instrumental analysis of Raw Material, packaging material, Water samples, In Process, Finished Product Samples and Stability Samples. The candidate should have experience on HPLC, GC UV, IR and Dissolution testing. To perform a Release testing, Dissolution profile study, challenge study ,Hold time study, RLD sample analysis, validation, verification, method transfer activity and API-Verification as when applicable. To perform instrument calibration and working standard qualification. Responsible to adherence of GLP and Health, Safety Environment system in Laboratory. To perform the task assigned by the supervisor/HOD as and when required. Should have good written and communication skill.