Senior Quality Assurance Officer

3 weeks 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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