OSD Production - Tableting & Coating Staff

PT. Daewoong Pharmaceutical Indonesia; Cikarang; On-site; IDR 66,960,000 - 111,600,000; Full time

Job summary

PT. Daewoong Pharmaceutical Indonesia is seeking an OSD Production - Tableting & Coating Staff in East Cikarang, West Java. This full-time role operates and maintains equipment for tablet and capsule production, ensuring quality, efficiency, and compliance with GMP standards.

You'll manage documentation, batch records, IPC sampling, and data integrity while supporting CAPA, QMS deviations, and process validations. A strong background in pharmacy or related sciences is required.

Qualifications

• Bachelor or Master degree in Pharmacy, Engineering or Sciences.
• Pharmacist qualification preferred.

Responsibilities

• Prepares and double checks GMP documents related to manufacturing.
• Creates/revises SOPs related to production and accurately indicate the related documents.
• Manages manufacturing data per ALCOA throughout the lifecycle to ensure data integrity.
• Prepares/reviews manufacturing batch records and operates tableting & coating equipment.
• Collects samples for IPC per instructions and records results in batch records.
• Monitors processes to identify issues and implements recurrence prevention measures.
• Investigates deviations via QMS and defines preventive actions.
• Conducts CAPA, change control and training as per recurrence prevention.
• Executes pilot production for technology transfer.
• Performs Process Validation, Cleaning Validation, and Qualification recordings.
• Prepares/reviews URS for new equipment purchases.

Skills

GMP knowledge

Data integrity (ALCOA)

Statistical data processing

English language proficiency

Microsoft Office

AI awareness

Education

Bachelor/Master in Pharmacy

Engineering/Sciences background

Tools

Microsoft Office Suite

Job description

OSD Production - Tableting & Coating Staff

About the role
We are seeking an experienced OSD Production - Tableting & Coating Staff to join PT. Daewoong Pharmaceutical Indonesia in East Cikarang, West Java. This is a full-time position that plays a vital role in our pharmaceutical manufacturing operations. As an OSD (Oral Solid Dosage) Production Staff member, you will be responsible for operating and maintaining specialised machinery used in the production of tablets and capsules. This position is essential to maintaining the quality, efficiency, and safety standards of our manufacturing processes, directly contributing to the delivery of high-quality pharmaceutical products to our customers.

Key responsibilities

• Prepares and double checks various GMP documents related to manufacturing.


• Creates/revises SOPs related to production and accurately indicate the related documents.


• Manages the generated manufacturing related data as per the ALCOA principle of conduct during the entire Life-cycle to comply with data integrity.


• Prepares/reviews the manufacturing batch record and the intermediate production work through operating the manufacturing equipment (tableting & coating).


• Collects the necessary samples for IPC as per the manufacturing instructions, performs IPC as per the IPC frequency, and then record the results in the manufacturing batch record.


• Through process monitoring, checks the issues that occur during production, and discusses with the related teams to establish recurrence prevention measures.


• Investigates deviations during the process through QMS to derive the root cause, and establishes measures to be taken to prevent recurrence.


• Conducts CAPA, change control and training according to recurrence prevention measures.


• Executes pilot production as per the production technology transfer.


• Performs PV as per the Process Validation protocol, and records and attaches the calculated data to the document.


• Performs CV as per the Cleaning Validation protocol, and records and attaches the calculated data to the document.


• Performs Qualification protocol, and records and attaches the calculated data to the document.


• Prepares/reviews the URS related to purchase/ maintenance of the new equipment.


• Performs real-time recording and monitoring along with the process flow.


• Conducts and completes production related education such as new employee training, OJT training, Plant GMP training, training for each department, problem prevention education and etc.


• Identifies the purchase list necessary for production and reflects in in the annual investment plan and proceeds the purchase following the purchasing process as per the annual investment plan (equipment, consumables, etc.). After completing the purchase through the purchasing system, registers the receipt and completes the settlement.

What we're looking for

• Bachelor or Master of Pharmacy. Engineering, Sciences; Pharmacist


• Good command in English especially in writing and speaking.


• Have fundamental knowledge in the manufacturing of pharmaceutical especially oral dosage form facility.


• 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).


• Understand and be proficient in the use of AI.

About us
PT. Daewoong Pharmaceutical Indonesia is a leading pharmaceutical manufacturing company dedicated to producing high-quality medicines and healthcare products. With a commitment to excellence, innovation, and regulatory compliance, we serve patients and healthcare providers across the region. Our facility in East Cikarang, West Java, represents our investment in state-of-the-art manufacturing capabilities and skilled workforce development. We operate under strict international pharmaceutical standards and are guided by values of integrity, quality, and customer care. Join our team and be part of a company that makes a meaningful difference in healthcare.