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

Skills Required

Validation, equipment qualification , Regulatory Requirements, Data Analysis, Computer System Validation