Senior Scientist I, Reference Standards Laboratory

Job Description:

Responsibilities

• Execution of allotted tests and completing the project as per timelines and troubleshoot the scientific aspects of the projects as on need basis.
• Coordination with Lab staff and supervisor to maintain the Lab as per GLP and safety practices.
• Verify and approve the project related Test protocols and Test kits received from RSE/CSU departments and any other supporting work from other departments on a needy basis.
• Supporting Verification and other departmental teams in terms of project review and approval whenever needed.
• Overall planning and coordination of all RSL projects as needed.
• Compilation of project reports and response to QA observations.
• Initial review of projects reports and final project review of other team’s projects on a required and priority basis.
• Completing the projects as per the project timelines and priorities.
• Preparation and review of SOP’s.
• Providing hands on training to the new joiners and existing reporting staff whenever required.
• Ensuring the calibration of the equipment as per the schedules.
• Planning chemicals, column. Glassware etc. and their procurement by coordination with lab operation and purchase department in advance keeping in mind the project deadlines.
• To maintain good relationship with other departments.
• Preparation, executing and completing IQ/OQ/PQ of new instruments.
• Preparation and planning for ISO-9001 & ISO- 17025 certification/recertification by participating actively, verification of protocols and related documents and take an active role in the internal as well as external audits and address the audit issues on a timely manner.
• Taking up any other additional responsibilities assigned by supervisor on a proactive basis.
• To involve in and support the laboratory investigations to identify and correct the issues.
• Maintaining proper communication with RSE / QA in resolving the technical issues.
• Has the responsibility to maintain internal databases consistently.

Qualification & Experience

• 7 to 10 years with relevant laboratory experience for Ph.D. candidates.
• 11 to 13 years with relevant laboratory experience for Master’s degree candidates.
• Proven track record of consistently delivering projects on time and with high quality for API’s.
• Expert in chromatographic analysis, particularly in HPLC, GC and IC.
• Proficient in other related analytical instrumentation such as Mass Spectrometry, Titration, IR, KF, UV, Thermal analysis, Elemental analysis, etc.