22 Sep
|
Aal Biosciences Research
|
Barwala
22 Sep
Aal Biosciences Research
Barwala
Job Title: Study Director
Experience: 4+ Years
Qualification: M.V.Sc / M.Pharm / M.Sc (Life Sciences)
Job Summary:
We are looking for a Study Director with 4+ years of experience in conducting GLP studies in compliance with OECD Principles of GLP & CCSEA guidelines.
Key Responsibilities:
Overall conduct and management of GLP studies as Study Director.
Preparation, review and approval of Study Plan, Amendments & Final Reports with dated signatures.
Ensure study is conducted as per Study Plan, SOPs and GLP requirements, with complete documentation of raw data & deviations.
Coordinate with QAU for timely submission of Study Plan/Amendments and ensure QAU statement in final report.
Ensure availability of validated systems, calibrated instruments, adequate resources, test systems & test materials.
Responsible for multi-site study coordination,
defining roles of PI and test sites.
Preparation and approval of Form-B before study initiation and maintenance of Form-D register as per CCSEA.
Preparation of SOPs, training of study personnel and maintenance of personnel files.
Ensure proper archiving of Study Plan, Raw Data, Reports & supporting materials after study completion.
Handle any other responsibilities assigned by TFM.
Required Skills:
OECD GLP, CCSEA Guidelines, Study Plan & Report Preparation, SOP, QAU Coordination, Form-B/Form-D
Pay: ₹20,000.00 - ₹55,000.00 per month
Perks:
Commuter assistance
Paid time off
Provident Fund
Work Location: In person
📌 Study Director Toxicology Barwala
🏢 Aal Biosciences Research
📍 Barwala