Senior Quality Management Specialist

5 days ago

Hyderabad Uttar Pradesh Warangal Nizamabad, India beBeeQuality Full time ₹ 6,00,000 - ₹ 8,00,000

Job Title: Senior Quality Management Specialist

The ideal candidate will have a proven track record of ensuring quality and compliance in IT projects. He/she will be responsible for planning, executing, and evaluating quality activities to meet project objectives.

Key Responsibilities:
  • Develop and implement quality strategies to ensure compliance with applicable laws and regulations
  • Lead quality efforts during assigned projects, including qualification and validation activities
  • Verify completeness and correctness of planned qualification/validation activities
  • Write/review/approve system documentation as per applicable standards
  • Perform reviews to ensure compliance and adherence to corporate and regulatory policies and procedures
  • SUCCESSFULLY interface with all levels of management and customers or suppliers to assure a consistent supply of quality products and services.
Requirements:

Education:

  • Bachelors Degree (or equivalent) in Computer Science, Information Systems Management, Mathematics, Informatics, or other related fields
  • Certification or accreditation in Information Security (CISM, CISA, CISSP etc.) is a plus
  • Fluent in written and spoken English

Experience:

  • 6-10 years of relevant experience in BioPharma IT Quality & Compliance departments

Skills:

  • Expert knowledge and hands-on working experience of Quality and Security Management in GxP, CSV, and GAMP
  • Good understanding of pharmaceutical validation requirements driven by health authorities like FDA
  • IT System Lifecycle (Requirement Management, Design, Testing, Deployment)
  • Software Development Methodologies: Agile, Dev / SecOPs
  • Quality and Process Management (CMMI, Six Sigma)

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