Quality Assurance Validation Supervisor

PT. Daewoong Pharmaceutical Indonesia; Cikarang; On-site; IDR 168,000,000 - 252,000,000; Full time

Job summary

PT. Daewoong Pharmaceutical Indonesia in East Cikarang, West Java, is seeking a Quality Assurance Validation Supervisor. You will oversee validation activities, lead a team of QA professionals, and ensure that processes, systems, and equipment meet regulatory requirements.

The role emphasizes Right-First-Time execution, calibration and validation, and the development of SOPs. A pharmacy or engineering background with 5+ years in pharma validation is preferred, along with strong English and data

Qualifications

• GMP knowledge and quality systems familiarity.
• Experience with data integrity and compliant documentation.
• Fluent in English written and spoken.

Responsibilities

• Prepare and implement Validation Master Plan (VMP) and schedules.
• Supervise calibration, qualification and validation per regulations.
• Develop and update SOPs and work instructions in QA department.
• Prepare validation/verification protocols and reports including supporting data.

Skills

GMP knowledge

Data integrity

English proficiency

Attention to detail

Statistical data processing

Education

Pharmacist degree

Bachelor of Pharmacy

Bachelor of Engineering

Tools

Microsoft Office

Job description

About the role

We are seeking a Quality Assurance Validation Supervisor to join PT. Daewoong Pharmaceutical Indonesia in East Cikarang, West Java. This is a full-time position that plays a critical role in ensuring the highest standards of quality and compliance within our pharmaceutical operations. As Validation Supervisor, you will oversee validation activities, lead a team of quality assurance professionals, and ensure that all processes, systems, and equipment meet stringent regulatory requirements. This position is essential to maintaining our reputation for excellence and safeguarding product integrity across our operations.

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 documentation.
• Prepare and/or review standard operating procedures and work instructions in Quality Assurance 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 to procedures.
• Prepare transportation verification protocols, reports, raw data and 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.
• Utilize, maintain, and store Quality Assurance Department documents and assets properly and correctly.

What we're looking for

• Minimum Pharmacist (preferable), Bachelor of Pharmacy, Bachelor of Engineering.
• Practical experience at least 5 (five) years of experience working in the Pharmaceutical Industry, especially in qualification and validation area or quality assurance.
• Have experience and fundamental knowledge in the manufacturing of pharmaceutical, biopharmaceutical, and/or cosmetic products 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.
• Good command in English especially in writing and speaking.
• Have good accuracy and attention to detail.
• Have knowledge of statistical data processing and be able to read and evaluate data.
• Able to communicate effectively with teams, other departments, and external parties.
• Able to operate computer and Microsoft Office (Word, excel, and power point).

What we offer

PT. Daewoong Pharmaceutical Indonesia is committed to supporting the professional development and wellbeing of our employees. We offer competitive remuneration packages commensurate with experience and expertise. Our benefits include comprehensive health and safety coverage, opportunities for continuous professional development and training in the latest pharmaceutical validation methodologies, and a structured career progression pathway within a reputable international pharmaceutical company. We foster a collaborative and innovative work environment where your contributions are valued and recognised. We encourage a healthy work-life balance and provide a supportive workplace culture that promotes employee engagement and retention.

About us

PT. Daewoong Pharmaceutical Indonesia is part of the Daewoong Group, a leading global pharmaceutical and medical device company headquartered in South Korea. Our mission is to develop and manufacture innovative, high-quality pharmaceutical products and medical devices that improve patient health and wellbeing. With operations in East Cikarang, West Java, we are committed to maintaining the highest standards of manufacturing excellence, regulatory compliance, and product safety. We are dedicated to creating a workplace where talented professionals can thrive, contribute to meaningful work, and grow their careers whilst supporting our commitment to healthcare excellence across the region and beyond.