Janssen India, the pharmaceutical division of Johnson & Johnson India, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neuroscience and analgesia, dermatology, infectious diseases and metabolic diseases. Driven by a strong dedication to the health and well-being of patients, Janssen India brings innovative products, services and solutions to people throughout the world.
Post : Associate Analyst - Quality Control
• To effectively plan the execution of tasks assigned by completing analyses right-first time and within analytical testing window.
• To perform analyses according to current effective protocol, specifications, analytical methods, and laboratory processes.
• To verify trending of results as per established laboratory procedure.
• To report results and submit the documentation for data validation in a timely manner, as per established laboratory procedure.
• To immediately escalate to Supervisor issues/ observations suspected to be not in conformity with applicable procedures /policies etc.
• To initiate Quality Issues identified as per applicable procedure, participate in the investigation, perform investigation analysis in timely manner, and provide necessary information to enable implementation of effective CAPA.
• To ensure trainings are completed on time in the electronic learning management system, and all tasks are performed only after completion of trainings on current effective procedures.
• To provide technical/scientific support to other lab personnel within the premise.
• To perform laboratory support activities as per training and perform tasks related to audit readiness.
• Responsible for executing activities in EDMS as per assigned roles and as per applicable procedures.
• To impart training to colleagues.
• To participate in project teams as analytical technical team member, as applicable.
• To attend (in-house) seminars, scientific meetings in own field
• To attend the Department meetings and participate in the initiatives for quality improvement process, as applicable.
• To compile data and collate information, such as required for regulatory submission, or preparation of work instructions and standard operating procedures.
• To execute the tasks according to the cGMP guidelines and established laboratory procedures
• To document execution details contemporaneously and verify completeness of execution record as per established laboratory procedure.
• To comply with procedure always and ensure lab is in state of audit readiness.
Quality & Compliance Responsibilities
• To ensure that respective guidelines on data integrity and laboratory control processes are followed as per established SOPs.
• To ensure immediate escalation of issues/observations not in conformity with applicable procedures /policies etc.
• Science / Pharmacy Graduate.
• Adequate knowledge of verbal and written communication skills in English language, including ability to effectively communicate with internal and external customers.
• Adequate computer proficiency
• Knowledge of analytical techniques and ability to identify gaps, root causes of issues and think out of the box to develop a solution.
• Must be able to work independently with minimum supervision to meet deadlines and maintain a positive attitude.
Qualification : Science / Pharmacy Graduate
Location : Greater Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality
End Date : 28th February, 2022
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