QA Validation Executive

QA Validation Executive

work outline icon3 - 5 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Zeiss Pharmaceutical Private Limited

time outline iconSamba, Jammu and Kashmir, India

Posted on 01-04-2024

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1 Vacancy

Description

  • Develop and execute validation protocols for processes, equipment, and systems in accordance with regulatory requirements and company standards.
  • Perform risk assessments and gap analyses to identify validation requirements and ensure compliance.
  • Review and approve validation documentation, including protocols, reports, and standard operating procedures (SOPs).
  • Analyze validation data, identify trends, and provide recommendations for process improvements.
  • Investigate deviations, non-conformances, and out-of-specification results, and implement corrective and preventive actions (CAPAs) as needed.
  • Collaborate with cross-functional teams, including R&D, production, engineering, and regulatory affairs, to ensure effective validation strategies and timely project completion.
  • Maintain validation documentation and records in accordance with regulatory requirements and company policies.
  • Support regulatory inspections and audits by providing validation documentation and participating in inspections as needed.

Category

Pharmaceuticals

Functional Area

Pharma Quality Assurance (QA)

Preferred Education

MPharm Pharmaceutical Quality AssuranceBTech / BE (Bachelor of Engineering)

Key Skills

Attention to DetailCommunication SkillsRegulatory ComplianceAnalytical ThinkingProblem-Solving Skills

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