Maya Anggrelana Zalmi

Quality Assurance Supervisor @ Biotis Pharmaceuticals Indonesia

About

Quality Assurance Pharmacist with 3+ years of experience in pharmaceutical manufacturing, including sterile product exposure. Demonstrated expertise in GMP/CPOB compliance, deviation investigation, CAPA management, Product Quality Review (PQR), and batch release activities.Experienced in managing high-volume batch release (>200 batches/month), conducting data-driven trend analysis using Minitab, and supporting continuous improvement initiatives. Strong background in document control systems, training management, and cross-functional collaboration across QA, QC, and Production.Brings a unique combination of Quality Assurance and Production experience, enabling a comprehensive understanding of end-to-end pharmaceutical processes, quality risk management, and data integrity.

Country

Indonesia

City

Sukabumi

Industry

Pharmaceuticals

Skill

Public Speaking, Memiliki keahlian PCR secara teori, Microsoft PowerPoint, Microsoft Excel, Riset, cGMP, Corrective and Preventive Action (CAPA), Minitab, Training, SOP Authoring, SOP Development, product quality review

Experience

Quality Assurance Supervisor

Biotis Pharmaceuticals Indonesia

2023-7 - Present · 3 yrs 3 mos

Document Control Center - Ensure all documents used are updated - Review the documents in every level documents - Handling the obsolete documents and conduct the document destruction Training - Coordinate training for employee in PT Biotis - Schedule training - Trainer for GDP (good documentation practice)

Quality Assurance Staff

Biotis Pharmaceuticals Indonesia

2023-3 - 2023-7 · 5 mos

Bogor, Jawa Barat, Indonesia

Generate PQR reports - Collect and complete the required data in the PQR report - Complete the Minitab chart on the PQR report and analyze the chart - Make a PQR report for drug products and drug substance Deviations Handling - Review the deviation reports from related departments. - Investigation of the deviation reports with the related departments Review the Batch Record - Review the batch records and ensure the testing parameters required the specifications - Follow up the deviation reports for deviation batch and ensure the status of deviation reports.

Quality Assurance Staff

PT. Mersifarma Tirmaku Mercusana

2021-8 - 2023-3 · 1 yr 8 mos

Sukabumi, West Java, Indonesia

Finished product release - Assist in the release of the finished product and ensure that the released product complies with cGMP. - Help coordinate the completeness of documents for the release of finished products. - Provide COA according to the request of the relevant department. Input Artwork standard design packaging material - Assist the packaging development department in updating packaging materials and assist in separating obsolete artwork documents and for immediate destroyed. Create of PQR and Trend Reports - Schedule of PQR (Product Quality Review) and Trend reports - Complete the required data on the PQR report - Perform a graphic analysis of process capability - Converting finished drug analysis data and IPC (In Process Control) on each specification for finished product into a graph of process capability analysis in Minitab. - Create PQR and Trend reports on schedule - Provide recommendations on products based on data and analysis on PQR reports - Provide trend data for related departments Additional - Create and revise SOPs - Trainer in the material on how to fill out Batch Record (BR) and GDP (Good Documentation Practices) - Assisting logistics in supervising and documenting the weighing of finished psychotropic drugs based on purchase orders