Job Title: Quality Assurance Specialist
We are seeking a skilled and detail-oriented Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of product quality and compliance in our electronic systems.
* Develop, maintain and implement quality assurance procedures, policies and systems.
* Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations.
* Investigate and address deviations, non-conformities and Corrective and Preventive Actions (CAPA) to maintain quality.
* Review and approve change controls related to GxP systems and lab equipment, ensuring appropriate impact and risk assessments.
* Apply ICH Q9 principles to qualify and mitigate risks in system-related changes or deviations.
Key Responsibilities:
* Quality Assurance Design and Oversight
* Regulatory Compliance
* Documentation and Reporting
* Quality Improvement Initiatives
* Training and Development
Requirements:
* Bachelor's degree in Science, Engineering, Quality or related field.
* Minimum 5 years of experience in quality assurance within a biotechnology, pharmaceutical or medical device manufacturing environment.
* Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.
* Excellent problem-solving and analytical skills.
* Detail-oriented with a strong commitment to maintaining high-quality standards.
What We Offer:
Competitive salary and benefits package, opportunities for professional growth and development, and a dynamic work environment.