QA Manager

Testing & Quality Assurance (Information & Communication Technology)

Full time

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PT. Selatox Bio pharma Corporation is a 100% owned subsidiary of Daewoong Pharmaceutical in Korea, which develops and produces BIOLOGICAL PRODUCT 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 decision to the result of deviation handling and change control.
• Handling of drug complaint, reject product and drug recall.
• Carry out duties as a responsible person of Pharmacovigilance in the company.
• Release or reject finished product for selling by consider all related factors.
• Coordinate and make sure implementation of calibration, qualification and validation program that conducted in the company.
• Do the assessment for product quality in the product quality assessment of yearly program.
• Initiate and participate in the internal and external audit implementation (audit to supplier, 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 make sure the program implementation of personnel training in the company.

Job Requirements:

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

[Only CV in English will be processed]

Your application will include the following questions:

Which of the following types of qualifications do you have? What's your expected monthly basic salary? Have you worked in a pharmacy before? How many years' experience do you have as a Quality Assurance Manager? Do you have experience with quality control processes? Which of the following languages are you fluent in? Do you have experience automating functional and non-functional tests?

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