Job Description

Conducting laboratory testing, not limited to validation, verification, transfer, and registration stability studies. The successful candidate shall possess solid hands-on technical abilities, a passion for their work and the impact it has on meeting the needs of patients. Effectively contributing basic technical knowledge and skills to a variety of projects within relevant disciplines. Interacting effectively with a variety of disciplines. Conducting routine research and design experiments with minimum assistance. Essential Duties and Responsibilities: Collect information for the analytical target profile. Propose techniques and develop analytical methods independently or with minimum support. Design studies and write protocols, reports, and procedures with minimal guidance. Participate in evaluation, validation, or transfer of analytical methods, including investigating failed acceptance criteria. Contribute routine scientific knowledge or expertise to research and development activities for achievement of project goals. Under direction, conduct routine research, developmental activities. Plan details of assigned tasks within specific parameters. Understand and apply applicable corporate and divisional SOPs. Employ appropriate techniques and methods to successfully conduct assignments within negotiated deadlines after receiving general instruction. Perform laboratory testing in a regulated environment. Demonstrate working knowledge of basic technical theories and principles within area of expertise for routine tasks. Develop knowledge and understanding of GxP and related regulations and guidance. Conduct RD stability testing as per the stability protocol to support registration of RD Product. Execute analytical method validations and transfers with minimal support. Accurately test the samples (Right First Time) and assess results for conformance to specifications. Support Laboratory investigations (OOS/OOT), Nonconformance/deviations to identify sound scientific root cause to follow the implemented corrective and Preventive actions. Sample receiving and data entry in LIMS. Adhere to cGxP requirements (ALCOA+), Data Integrity, Quality Culture and Compliance Level. Ownership of SOPs of relevant techniques / procedures. Troubleshoot issues and propose solutions. Maintain lab equipment and report on malfunctions. Good knowledge of laboratory health and safety standards. Demonstrate the ability to identify risks, issues, and identify opportunities for improvement of existing processes, technologies, and approaches by providing sound scientific rationale. Collaborate with global teams across various functions (ex. quality, regulatory, operations, manufacturing, etc). Maintain knowledge of relevant QSR and other regulatory requirements related to RD to ensure compliance in all research, data collection and reporting activities. Qualifications: Knowledge of regulatory validation stability guidelines and skills for testing products within relevant discipline. Possess relevant practical knowledge on analytical techniques like HPLC/UPLC, GC, Titrations, AAS etc, Possess relevant laboratory/technical, writing, and computer skills. Able to work in a team environment appropriately supporting others. Self-motivated and takes personal responsibility for getting the job done. Ability to objectively assess, organize, and clearly communicate complex information. Understand the importance of project schedules and contribute to efforts beyond own scope of responsibilities to ensure project milestones are met. Ability to adapt to shifting priorities. Ability to demonstrate critical thinking and problem-solving skills. Handling of software like Empower, Chromeleon, LIMS etc, Good learning agility and communication skills. Possessing relevant computer and technical skills including M.S word, spreadsheets etc