
Senior Scientific Officer
2 days ago
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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