※ Submit your Application (Submit Your CV) to: https://linktr.ee/daewoong_pharmaceutical

Quality Assurance Supervisor
Location: Cikarang

Responsibilities

• Oversee the QA staff, providing guidance and mentorship. Foster a team-oriented environment while ensuring that team objectives align with overall quality objectives.
• Direct and manage all quality assurance activities related to the production of aseptic pharmaceutical products. Ensure that all processes, procedures, and products comply with regulatory requirements.
• Lead the verification process of analytical test methods, ensuring rigorous standards are met and maintained.
• Ensure the review and verification of compendium test methods (USP, EP, JP, etc.) are thoroughly conducted.
• Analyze and monitor guidance and regulations regarding product approval and registration in various international markets. Manage the registration statuses for targeted countries.
• Oversee and support the transfer of analytic technology for test methods and guide the preparation of validation documents in English.
• Lead environmental monitoring trend analysis and evaluate disinfectant effectiveness for aseptic processes, ensuring a sterile quality environment.
• Ensure strict adherence to Good Manufacturing Practices, conducting regular audits and inspections to identify and resolve compliance issues.
• Write, review, and approve validation master plans, validation plans, SOPs, and other crucial validation documentation, ensuring they are fit for purpose.
• Oversee the preparation of validation plans and protocols for production processes, including process validation, cleaning validation, and filtration validation.
• Develop and evaluate SOPs, Work Instructions, and Forms, and supervise the implementation of a record-keeping system to track all QA activities.
• Identify opportunities for process improvements and implement best practices within the QA team to enhance efficiency and effectiveness.

Requirements

• Bachelor’s degree in Life Sciences, Chemistry, or a related field.
• Over 5 years of experience in quality assurance or validation in a pharmaceutical company, with specific experience in aseptic pharmaceutical products.
• In-depth knowledge of GMP and regulatory requirements applicable to sterile product manufacturing.
• Demonstrated leadership skills and experience managing a team.
• Exceptional written and verbal communication skills in English.
• Strong problem-solving abilities and analytical skills.

※ Submit your Application (Submit Your CV) to: https://linktr.ee/daewoong_pharmaceutical