Quality Assurance Manager

1 day ago

Warangal Nizamabad Hyderabad Uttar Pradesh, India beBeeQuality Full time ₹ 1,04,000 - ₹ 1,30,878
Job Description

We are seeking a Senior Quality Management Specialist to join our team. The successful candidate will be responsible for ensuring the quality of our products and services, identifying areas for improvement, and implementing solutions.

  • Accomplish ITQM objectives in assigned projects by planning, executing, and evaluating quality activities.
  • Accountable for ensuring that assigned projects implement security and compliance with applicable laws and regulations.
  • Lead, coordinate, and control the performance of quality and validation efforts during assigned projects.
  • Develop a Quality/Validation strategy which defines actions, deliverables, responsibilities, and procedures.
  • Verify completeness and correctness of planned qualification/validation activities via a Qualification/Validation Report.
  • Write/review/approve system documentation as per applicable standards, compile input from subject matter experts, and seek approval from stakeholders.
  • Perform reviews to ensure compliance and adherence to corporate and regulatory policies and procedures.
Required Skills and Qualifications
  • Bachelor's 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.
  • 6-10 years of relevant experience in BioPharma IT Quality & Compliance departments.
Benefits

As a Senior Quality Management Specialist, you will have the opportunity to work on a variety of projects and contribute to the development of our quality management systems. You will also have access to ongoing training and professional development opportunities.

ITQM Skills
  • Has successfully managed quality during multiple international and/or cross-functional IT projects and/or operations.
  • Expert knowledge and hands-on working experience of Quality and Security Management in the following areas/disciplines:
  • GxP, CSV, and GAMP.
  • Good understanding of pharmaceutical validation requirements driven by health authorities like FDA etc.
  • IT System Lifecycle (Requirement Management, Design, Testing, Deployment).
  • Adequate project management skills to plan quality and information security tasks and monitor their implementation during assigned projects.
  • Software Development Methodologies: Agile, Dev/SecOPs.
  • Quality and Process Management (CMMI, Six Sigma).

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