Senior Scientific Officer / Sr. Executive

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