QA Manager

PT. Selatox Bio pharma Corporation is a 100% owned subsidiary of Daewoong Pharmaceutical in Korea, which develops and produces biological products such as botulinum toxin and aims to expand globally. Daewoong Pharmaceutical is one of the leading pharmaceutical companies in Korea with a sales revenue of over 1.3 billion USD. The company is actively focusing on research and development as well as global expansion. Daewoong Pharmaceutical invests more than 15% of its revenue into research and development and has over 100 research and business partners worldwide.

We plan to establish a production base for botulinum toxin products in Indonesia as a global bio hub strategic base and target the global market with better accessibility and services through the development and production of competitive new products.

We have a vision of becoming a “2030 leading global biopharmaceutical company” with the goal of becoming a world-class botulinum toxin company.

Job Responsibilities:

• Developing and implementing quality assurance policies and procedures.
• Ensure compliance with GMP and ensuring the quality system is implemented in accordance with the latest regulations.
• Ensure the fulfillment of GMP technical requirements or regulations of the BPOM related to the quality of the finished product.
• Evaluating and giving approval to product stability data and other registration document data as well as managing other Pharmaceutical Industry License in accordance with the provisions of the Ministry of Health and BPOM of the Republic of Indonesia.
• Evaluating and making decisions on the results of deviation handling and change control.
• Handling of drug complaints, rejected products, and drug recalls.
• Carry out duties as a responsible person of Pharmacovigilance in the company.
• Release or reject finished products for selling by considering all related factors.
• Coordinate and ensure implementation of calibration, qualification, and validation programs conducted in the company.
• Conduct assessments for product quality in the product quality assessment of yearly programs.
• Initiate and participate in the internal and external audit implementation (audit to suppliers, drug manufacturers, and laboratories on a contract basis, Toll Out Partner).
• Provide approval and conduct monitoring of materials suppliers, drug manufacturers, and analysis based on contracts.
• Coordinate and ensure the program implementation of personnel training in the company.

Job Requirements:

• Bachelor's degree (or higher) from a recognized Faculty of Pharmacy.
• Minimum 3 years experience as a Quality Manager in Pharmaceutical Industries.
• Preferably Senior Manager who specializes in Quality Control/Assurance/or equivalent.
• English: oral & written; computer literate (Microsoft skills).
• Able to speak Korean will be an added advantage.
• Ability to embrace challenges, critical thinking to resolve arising issues with a business focus.
• Good interpersonal and communication skills.
• Active involvement in professional organizations would be an added advantage.

[Only CV in English will be processed]