Job Description
Full details about the role and requirements
Yukerja Summary
The Validation Supervisor role at Daewoong Indonesia is curated from JobStreet (category Manufaktur). Note the work location (Cikarang Pusat, West Java) before applying. Yukerja.com is not the employer — applications are handled on the official source site.
About the role
PT. Daewoong Pharmaceutical Indonesia is seeking a dedicated and experienced Validation Supervisor to join our Quality Assurance & Control team. This is a full-time position based in Cikarang Pusat, West Java. As Validation Supervisor, you will play a critical role in ensuring that all manufacturing processes, equipment, and systems comply with regulatory standards and company quality specifications. This position is essential to maintaining the integrity of our pharmaceutical operations and protecting product quality for our customers.
Key responsibilities
Prepare and implement Validation Master Plan (VMP) and its schedules also update VMP and its schedules regularly.
Supervise and/or carry out all calibration, qualification, and validation runs well, smoothly, and correctly also comply with current regulations.
Implement Right-First-Time (RFT) principles to all calibration, qualification, and validation jobs and documentations.
Prepare and/or review standard operating procedures and work instructions in Validation Department also update standard operating procedures and work instructions regularly.
Prepare process validation and cleaning validation protocols, reports, raw data as well as its supporting documents including holding time studies, etc.
Prepare qualification protocols, reports, raw data as well as its supporting documents including temperature mapping, etc.
Prepare internal and external calibration documentation as well as ensure supporting equipment for internal calibration are used according procedures.
Prepare transportation verification protocols, reports, raw data as well as its supporting documents.
Execute computerized system validation protocols as well prepare reports, raw data, and its supporting documents.
Provide training related to calibration, qualification, and validation jobs to validation inspectors.
Also be responsible for qualification and validation activities for OSD production facility.
Carry out other jobs assigned by Validation Manager
What we're looking for
Bachelor's degree in Pharmaceutical Science, Chemical Engineering, or a related discipline
Minimum 2 years of experience in pharmaceutical manufacturing or quality assurance with a focus on validation activities
Proven experience with IQ/OQ/PQ protocols and validation documentation in a GMP environment
Strong knowledge of pharmaceutical regulatory requirements, including FDA 21 CFR Part 11, ICH guidelines, and Indonesian pharmaceutical regulations
Demonstrated leadership and supervisory experience with the ability to manage and mentor team members
Excellent analytical and problem-solving skills with attention to detail
Proficiency in Microsoft Office applications and preferably experience with LIMS or similar quality management systems
Strong verbal and written communication skills in English and Indonesian
Knowledge of ASEAN Cosmetic Directive (ACD) or related regional standards is advantageous
Experience with process validation, equipment qualification, or utility system validation is highly desirable
Commitment to continuous improvement and maintaining the highest standards of quality and compliance
Preferred Skills
Good command in English especially in writing and speaking.
Have experience and fundamental knowledge in the manufacturing of pharmaceutical especially biopharmaceutical and oral dosage form facility also knowledges and skills related to calibration, qualification, and validation.
Have fundamental knowledge about GMP or other quality systems also good documentation practices and data integrity principles.
Have knowledge of statistical data processing and able to read and evaluate data.
Able to operate computer and Microsoft Office (word, excel, and power point).
About us
PT. Daewoong Pharmaceutical Indonesia is a subsidiary of Daewoong Company, a leading global pharmaceutical manufacturer with a strong reputation for quality, innovation, and regulatory compliance. We are committed to developing and manufacturing pharmaceutical products that meet the highest international standards whilst serving the healthcare needs of our customers and communities. Our facility in Cikarang Pusat is equipped with state-of-the-art manufacturing and quality control capabilities, and we maintain strict adherence to Good Manufacturing Practice (GMP) standards. We pride ourselves on our commitment to quality, regulatory excellence, and the professional development of our workforce. Joining our team means becoming part of a globally recognised pharmaceutical company with a strong commitment to quality, innovation, and employee development.
Apply now
If you meet the above requirements and are interested in joining PT. Daewoong Pharmaceutical Indonesia as a Validation Supervisor, we encourage you to submit your application including your CV and a cover letter. We look forward to hearing from you!