Overview
On Site QA Staff Jobs in Cilincing, Jakarta, Indonesia at PT Etana Biotechnologies Indonesia
Title: On Site QA Staff
Company: PT Etana Biotechnologies Indonesia
Location: Cilincing, Jakarta, Indonesia
Company Description: Established in 2014, PT Etana Biotechnologies Indonesia (Etana) is an emerging producer of high-quality, affordable and innovative biopharmaceuticals to treat a range of metabolic, autoimmune and other major life-threatening diseases, including cancer. In order to best serve Indonesian patients, Etana has established a network of strategic alliances and partnerships with international pharmaceutical producers with a strong track record in researching and developing safe and efficacious pharmaceuticals, enabling Etana to offer new treatments to the Indonesian market. At the same time, Etana is working to build Indonesia’s human resources and its own research and production capabilities by establishing environmentally-friendly, multi-purpose biopharmaceutical manufacturing and research facilities, staffed by top graduates from Indonesia’s foremost medical research and educational institutions. Job Description:
Conduct real time investigation on site of event, deviation, and other non-conformance to ensure that proper investigation is performed to address the issue
Supervise real time in critical production process and in-process control (IPC) activities to ensure activities are conducted in compliance with applicable procedure
Perform batch documentation review during process or after process on site to ensure that all products are manufactured in accordance with cGMP and registration dossier
Provide real time quality impact assessment of any nonconformance/issue which has potential impact to product quality
Perform CAPA Effectiveness check on site
Conduct Quality Management System Gap analysis for topic related to Quality Assurance
Demonstrate and lead by example for the implementation of Good Documentation Practice
Conduct regular oversight with proper evidence
