Daily responsibilities and challenges
Jolien describes her job as primarily managing changes and non-conformities within the company's processes. "whether it's a customer complaint or an internal error, my role involves identifying what went wrong and adjusting our processes to prevent future issues," she explains. This could involve documentation changes, such as when a lab moves or new equipment is installed—everything must be meticulously documented to ensure compliance and traceability.
A typical day for Jolien is varied and dynamic. "it ranges from supporting lab staff in drafting their own non-conformity reports to conducting internal audit reports for senior staff like Bram," she notes. This diversity keeps her role challenging and engaging.
The importance of quality assurance
In pharma production, QA is crucial due to the direct implications on patient safety. While eyetec's particle test samples do not reach patients directly, they play a significant role in training and preparing those who will work in production environments where quality is non-negotiable. "Ensuring our particle test samples are of high quality helps future pharma professionals understand the importance of stringent quality measures from the start," Jolien adds.
Skills and education
Jolien's role requires a deep understanding of GMP regulations and industry standards, which she continually enhances through ongoing training and education. She highlights the importance of technical writing and structured problem-solving skills, which are critical in her role to communicate complex information clearly and without ambiguity.
Contributions to regulatory compliance
Jolien's involvement extends to supporting external audits and regulatory compliance for clients. She works alongside Bram, eyetec's QP and compliance director on projects that involve new pharmaceutical products and clinical trials, ensuring that all processes meet the stringent requirements set forth by regulatory bodies.
The role of internal audits
A significant part of Jolien's job involves managing internal audits and ensuring compliance with ISO standards. "every three years, we thoroughly review our quality manual to ensure our processes align with our quality system's expectations. it's a rigorous process that requires a critical eye and a deep understanding of our internal workflows," she details.
Future aspirations and goals
Looking ahead, Jolien is excited about the potential for growth and learning in her position. "I'm looking forward to potentially contributing to our GMP Summer School presentations and diving deeper into specific GMP knowledge areas, like Annex 1, which deals with sterile medicinal product manufacturing," she shares.
Jolien's role as a QA officer at eyetec illustrates the importance of quality assurance in the pharmaceutical industry. Her daily efforts help ensure that all changes, non-conformities, and customer feedback are handled with the utmost attention to detail.
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