Cindy Winando

Cindy Winando is a dedicated Quality Assurance Compliance professional at PT. Medifarma Laboratories, where she plays a pivotal role in ensuring the highest standards of pharmaceutical quality and regulatory adherence. With a strong foundation in pharmacy, having graduated from Universitas Indonesia in 2019 with a Bachelor of Pharmacy and subsequently earning an Apothecary degree in 2020, Cindy brings a comprehensive understanding of GMP principles, pharmaceutical manufacturing processes, and quality management systems. Her current responsibilities encompass managing the CAPA (Corrective and Preventive Action) system, where she meticulously handles deviations, OOS/OOT investigations, and ensures timely closure and effectiveness of CAPA actions. She actively reviews Standard Operating Procedures (SOPs) related to manufacturing processes, ensuring they align with current regulations and industry best practices.

Cindy’s expertise extends to conducting internal audits and coordinating external inspections, which are critical for maintaining compliance with ISO 14001 standards and other regulatory requirements. Her proficiency in Quality Risk Management (QRM) enables her to identify potential quality issues proactively, facilitating risk mitigation strategies across manufacturing and quality assurance functions. She is also involved in Change Control Management, ensuring that any modifications in processes or equipment are thoroughly evaluated and documented to prevent compliance gaps. With experience in regulatory affairs and product registration spanning 1.5 years, Cindy is well-versed in navigating complex regulatory landscapes.

Her skill set includes statistical data analysis, laboratory skills, and a strong understanding of pharmaceutical quality systems, making her a valuable asset to PT. Medifarma Laboratories. Cindy’s commitment to continuous improvement and her proactive approach to quality assurance underpin her contributions to delivering safe, effective, and compliant pharmaceutical products.