Job Description Are you a passionate scientist with a strong background in development, tech transfer, scaleup activity, evaluating the process? Join our innovative team at our state-of-the art Global R&D Centre , where your expertise will contribute to the development of life-changing therapies. Key Responsibilities What Youll Be Doing: Works within standard operating procedures and/or scientific methods. Work closely with CRD, ARD and PRD teams to ensure project completion within defined timelines. Equipment selection and sizing- Ensure the selected equipment for scale up should match the process requirement. Ensure the availability of scale up study as per guideline and within agreed timelines. Coordinate with GMP teams to enable Technology Transfer to manufacturing. Ensure the completion of nGMP and GMP campaign as per agreed timelines. Ensure the EHS compliances at lab. Generating required Reports. Responsible for completion of tasks by CFT; execution of batches at plant. Work closely & coordinate with all internal and external stakeholders to ensure smooth technology transfer to selected commercial sites. Responsible for addressing operational/ technical process related challenges by discussing with supervisor/ CFT. Understanding of cGMP requirements. Competencies Required Follow established Procedure and methodologies to develop solution to solve scientific / technical problem of limited scope Works independently with little guidance Responsible for delivery of project tasks Uses established process to solve problems Complete understanding of scientific/ technical principles, theories and concepts in the field. Understanding of Process Safety principles. Interested candidate can share their profile on jasleen.kaur@tapi.com or connect on 8076954558.
Job Description: 24 7 audit readiness. Participation in internal, external, regulatory audits. Ensure 100% participation in trainings against CAPAs. Responsible for initiation and investigation on LIR, OOS, OOT & boarder line results and reporting them to the in-charge. Supporting to share required documents from QC to RA/ other requirement. Determining team priorities in accordance with the plants needs, while coordinating with the team leader /Manger. Follow up the housekeeping, cGMP, GLP and Safety Guideline in laboratory. Sampling and analysis of RM / FG / intermediates / cleaning samples based on requirement and result entry in analytical sheet, QA form, LIMS and online documentation as per data integrity norms. Perform analytical test according to the monograph and SOP. Responsible for calibration and verification of instruments. Maintaining of reserved samples room and chambers / autoclaves / incubators. Responsible to work in shift as per requirement. Help to in charge in preparation of documents related to department (like STPs, SOP’s and etc.) Ensure the sampling of finished products, Raw material, Intermediate and sending sample to outside laboratory for analysis. Must be ensured sampled, approved and rejected labels timely as required. Responsible to maintain the stock record of chemicals and reconciliation of standards. Any other job assigned by the Manger -QC Manger or group leader-QC Qualifications: Preferred experience with Wet lab instruments/techniques including but not limited to KF Titrator, Auto-titrator, analytical balance, FTIR, Polarimeter, UV, X-ray Diffraction, etc. At least 5-years of relevant experience with Master of science (Chemistry).