Senior Scientific Officer

1 week ago

Baddi, 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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