Job Summary
We are seeking an experienced QA associate to join our quality team. The ideal candidate will have a strong background in quality assurance, a keen eye for detail, and a deep understanding of industry regulations. This role is crucial in ensuring our products meet the highest standards of quality and compliance, thereby maintaining customer satisfaction and regulatory adherence.
The QA associate works closely with various departments, including production and Quality control, to ensure that the day-to-day quality assurance activities are carried out efficiently and effectively. Key responsibilities include release of incoming raw materials, supplier management activities, root cause analysis, batch record review and managing the archive of quality records.
The ideal candidate will have a strong background in quality assurance within a manufacturing environment, excellent analytical skills, and the ability to communicate effectively with both internal teams and external suppliers.
Key Responsibilities
* Batch record review, including deviations and CAPA’s
* Release of incoming raw materials
* Supplier management activities
* Continuous improvement including training, changes and management review.
* Manage the archive of quality records to ensure they are properly stored, organized, and easily retrievable.
Profile
* Bachelor degree in Chemistry, Engineering, or a related field
* Minimum 3 years of experience in quality assurance, preferably within manufacturing in the pharmaceutical or radioisotopes industry.
* Experience in working in a GMP/GDP environment is a plus
Skills and Competencies:
* In-depth understanding of quality assurance principles and methodologies.
* Familiarity with regulatory requirements and industry standards (e.g., ISO 9001, cGMP, FDA).
* Excellent attention to detail and analytical skills.
* Strong written and verbal communication skills.
* Ability to work independently and as part of a team.
* Proficiency in Microsoft Office (Word, Excel, PowerPoint).
* Quick learner and able to work in a fast-changing environment
* Willingness to work in a controlled environment with adherence to strict safety and regulatory protocols