Quality Assurance Specialist

5 days ago

Hyderabad Secunderabad Telangana, India beBeeQuality Full time ₹ 1,04,000 - ₹ 1,30,878

Job Title: Quality Assurance Specialist

Main Responsibilities:
  • Oversight of all production and testing activities, ensuring compliance with current Good Manufacturing Practices (cGMP), including data integrity and electronic compliance.
  • Support exception investigations, review and approval of production, quality control, and laboratory records, as well as Master Batch Record reviews.
  • Collaborate on Operational Excellence improvement projects and serve as a Qualified Person for batch release in compliance with registration requirements.
  • Report technical complaints, adverse events, and special case scenarios related to products within 24 hours of receipt.
  • Distribute marketing samples (where applicable).
Key Performance Indicators:
  • Timely and compliant release of dosage forms.
  • No complaints about inspections by authorities in your area of responsibility without prior notice and communication.
  • Successful support of continuous improvement projects.
  • Batch release in compliance with registration requirements.
Requirements:

Work Experience:

  • Functional breadth, including pharmaceutical industry or biotechnology experience with environmental monitoring.
  • Collaboration across boundaries.
  • Cleanliness zones management.

Skills:

  • Continuous learning and professional development.
  • Dealing with ambiguity and uncertainty.
  • GMP procedures knowledge.
  • Quality assurance (QA) expertise.
  • Quality control (QC) testing skills.
  • Quality standards awareness.
  • Self-awareness and personal growth.
  • Technical expertise and intelligence.

Languages:

  • English proficiency.

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