Senior Scientific Officer

4 weeks ago


New Delhi, India Panacea Biotec Full time

JOB SUMMARY:Senior Scientific Officer- Validation (QA) shall be responsible for ensuring the quality and efficacy of vaccine formulations (Vaccine Drug Product Plant,Baddi). This position will be responsible for overseeing the Qualification/ validation of various Equipment/ System like HVACFilling line, Autoclave, Tunnel, Utilitiy systems, etc.RESPONSIBILITIES:- Oversee the execution of validation activities, including data collection, analysis, and reporting. - Execution and review of Equipment Qualification/ requalification of Autoclave, Vial Washing machine, Depyogenation Tunnel, Vial Filling & sealing machine, Tanks, etc. - Execution and review of Qualification/ requalification of HVAC system including Smoke Flow Pattern. - Execution and review of Temperature mapping of rooms & Equipments. - Qualification of various Utilities systems like purified water, WFI, pure steam, compressed air and Nitrogen gas. - Having exposure on Computer System Validation. - QA Oversight for Engineering department. - Monitor progress against validation timelines and identify potential risks or issues. - Collaborate with cross-functional teams to define validation objectives, scope, and protocols. - Ensure that validation plans align with regulatory requirements and company standards. - Analyze validation data to assess the effectiveness and consistency of Equipments .SPECIFIC JOB KNOWLEDGE, SKILLS AND ABILITIES- Strong understanding of vaccine formulation processes, regulatory requirements, and validation methodologies. - Experience in developing and executing validation plans. - Proficiency in data analysis and reporting. - Must be proficient in preparation of documents such as Protocols, SOP, specifications, Gap assessment, risk assessment - Must have experience to handle the QMS element i.e. deviation, change control, CAPA, incident etc. - Must be able to effectively communicate with large groups and work collaboratively. - Excellent verbal and written communication


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