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**Quality Assurance Specialist: Pharmaceutical Sterilization**
- We are seeking a skilled Quality Assurance professional to ensure the quality and compliance of pharmaceutical products.
- The ideal candidate will have 10-15 years of experience in laboratory QA and a strong understanding of cGMP and regulatory standards.
You will be responsible for reviewing and verifying analytical data from chemical and microbiological analysis, ensuring data integrity and compliance with regulations. This includes approving Certificates of Analysis (CoA) for final product release.
Your key responsibilities will include:
- Reviewing and analyzing quarterly trends for environmental monitoring, personnel monitoring, and out-of-specification (OOS) results.
- Conducting and reviewing investigations related to laboratory incidents, OOS, and out-of-trend (OOT) results.
- Identifying root causes and recommending corrective and preventive actions (CAPAs) to ensure product quality and safety.
- Collaborating with microbiology and analytical teams to implement corrective measures based on trend analysis and maintain a sterile manufacturing environment.
This is an excellent opportunity to work in a dynamic pharmaceutical company and make a meaningful contribution to the development of safe and effective medicines.
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