Quality Assurance Specialist
We are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of the quality team, you will play a vital role in ensuring the quality and integrity of our products.
Responsibilities:
* Oversee the qualification and validation of facilities, equipment, and systems to ensure compliance with regulatory requirements.
* Develop and implement quality assurance strategies to prevent defects and ensure customer satisfaction.
* Provide support during regulatory inspections and audits to ensure compliance with industry standards.
* Maintain a thorough understanding of cGMP regulations and guidelines related to quality and validation.
* Coordinate quality assurance activities to ensure timely delivery of project results.
Requirements:
* Bachelor's degree in a scientific or engineering-related field (e.g., chemistry, biology, engineering).
* At least 5 years of experience in quality assurance or a related field in a regulated environment.
* Proven knowledge of validation requirements for cGMP manufacturing facilities.
* Familiarity with GxP regulations applicable to biologics manufacturing (e.g., EU-GMP, FDA, ISO) and industry standards for validation (e.g., GAMP, ISPE, ISO, ASME, BPE).
* Excellent problem-solving skills, including experience with root cause analysis methods.