Key responsibilities of a Quality Specialist include:
About the Role
* Conduct thorough auditing and review of batch documentation to ensure adherence to SOPs, GMPs, and regulatory requirements.
* Verify and approve production and analytical documentation to ensure compliance with SOPs, GMPs, and regulatory standards.
* Manage product recalls and stock recoveries as needed.
* Investigate and resolve complaints, deviations, change controls, and CAPAs.
* Perform assignments to meet compliance, efficiency, innovation, accuracy, and safety benchmarks in accordance with regulatory requirements.
The ideal candidate will have experience in the pharmaceutical or chemical industry or a government drug-regulatory agency, with a working knowledge of cGMP regulations. They must possess effective communication and interpersonal skills, a degree in a Quality, Science, or Engineering discipline, and at least 3 years of industrial experience.
Key qualifications: Strong understanding of quality systems, excellent analytical and problem-solving skills, ability to work independently and collaboratively, strong attention to detail, and proficiency in Microsoft Office.