Test Item Controller

Department: TICO (Test Item Control)

No of Requirements: 2

Experience: 0-3 Years

Qualification: B.E/B.Tech(Chemistry, Pharmacy, Life Sciences, Biotechnology Toxicology,Biomedical)

Key Roles & Responsibilities:

Responsible to assist the TICO / Deputy TICO, in a supportive role, in performing the functions below:

• Responsible for the receipt, identification, characterization, labelling, handling, storage, archival, distribution, and disposal of all test items, reference, and control items, and related documentation such as TIDS & TRF/ Sponsor letter/ MSDS/ COA/ ATR.
• Responsible for maintaining and recording all Test Item-related information and logs, as per relevant in-house SOPs.
• Responsible to produce the test item related data that are attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available (ALCOA+) in all its forms, i.e., paper and electronic.
• Responsible to measure the Test Item, wherever applicable, and to calculate, wherever required, the Test Item quantity required at the Test Facility in order to perform all tests/studies required by the sponsor, including the discussion sample and sample for retention at the Archives.
• Responsible to document and communicate any visible differences between the physical test item and the related documentation provided by the sponsor/manufacturer.
• Responsible to measure/weigh and dispense the Test Item sample as requested by the study teams, along with adequate Test Item-related documentation, and to communicate to the study teams any updates on test item information received from the sponsor through the project coordinators.
• Responsible for managing the physical Test Item Control facility infrastructure to ensure that its integrity is maintained.
• Responsible to monitor and maintain adequate documentation for the same as per relevant in-house SOPs.

Job Type: Full-time

Benefits:

• Health insurance
• Provident Fund

Work Location: In person