Senior Quality Assurance Specialist
2 days ago
Job Summary:
Harba Solutions Inc. is seeking a highly skilled Senior Quality Assurance Consultant to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the highest standards of quality and compliance in our pharmaceutical manufacturing processes.
Key Responsibilities:
- Develop and implement quality assurance policies and procedures to ensure compliance with FDA, EMA, and other international regulatory requirements.
- Lead and participate in internal and external audits, including FDA and other regulatory agency inspections.
- Design and execute validation and verification protocols for manufacturing processes, equipment, and systems.
- Collaborate with R&D, manufacturing, and other departments to ensure quality considerations are integrated into product development and manufacturing processes.
- Provide leadership and mentorship to junior QA staff, offering guidance on best practices, regulatory compliance, and QA processes.
- Develop and review standard operating procedures (SOPs), quality manuals, and other documentation related to quality assurance.
Requirements:
- Bachelor's degree in Chemistry, Biology, or a related field. Advanced degrees or certifications in Quality Assurance, Regulatory Affairs, or Pharmaceutical Sciences are a plus.
- Minimum of 5 years of experience in quality assurance within the pharmaceutical industry.
- In-depth knowledge of FDA, EMA, and other international regulatory requirements related to pharmaceutical manufacturing and quality assurance.
- Proficiency in quality management systems (QMS), validation techniques, and GMP compliance.
- Strong analytical and problem-solving skills, with the ability to assess complex quality issues and implement effective solutions.
- Excellent verbal and written communication skills, with the ability to clearly articulate technical information to both technical and non-technical stakeholders.
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