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