Job Description

THE OPPORTUNITY

• Based in Singapore, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on the Straits Times and Statista’s list of Best Employers in Singapore for three consecutive years (2021, 2022, 2023).
• Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.
  We are seeking an Operation Support Specialist to play a crucial role in coordinating and supporting all manufacturing-related activities for the Biotech Sterile Integrated Process Team (IPT). In this position, you will be responsible for ensuring an adequate inventory of manufacturing aids (MA) and consumables used in the manufacturing process. Your efforts will contribute significantly to the timely release of batches, ensuring the delivery of our products to patients.

WHAT YOU WILL DO:

Reporting to the hiring manager, you will assist with batch record review and manufacturing inventory management. Your specific responsibilities will include:

• Assisting in the management of compliance and exception writing with shop floor staff.
• Completing post-manufacturing batch record reviews (both Paper and MES) and leading initiatives to improve right-first time (RFT) metrics.
• Maintaining proper filing and safekeeping of all relevant manufacturing documents.
• Supporting the execution and implementation of MES changes to Master Batch Records (MBR).
• Leading change controls and executions for manufacturing while liaising with departments such as PTO/Process Engineering, Quality, and Manufacturing.
• Authoring and revising documents including batch records, manufacturing labels, electronic logs (eLogs), Standard Operating Procedures (SOPs), and job aids for production use.
• Ensuring inventory accuracy and supporting stock adjustments and/or reversals related to manufacturing (e.g., Work Orders, Transaction Requests, and Goods Issues).
• Leading or supporting material qualification efforts.
• Processing Purchase Orders (POs) for both Bill of Materials (BOM) and non-BOM items to support IPT operations.
• Collecting data for Annual Product Reviews (APR), profit planning, and management of Tier processes.
• Performing incident and investigation write-ups for IPT operational events.
• Driving and/or supporting the implementation of actions for all incidents, investigations, and audits.
• Participating in continuous improvement projects related to batch release and RFT strategies to contribute to the overall success of the plant Hoshin plan.
• Executing any other duties as assigned by the Manager.

To succeed in this role, you should have a Diploma or Degree, with a minimum of 3 years of experience in an operations environment. Additional qualifications include:

• Strong understanding of applicable regulations and divisional policies/guidelines, particularly in Cleaning and Housekeeping, Environmental Control, Process/Cleaning/Equipment Validation, Change Control, and Manufacturing Practices.
• Awareness of good stewardship practices, including cGMP, regulatory inspection preparation, and Environmental Health and Safety (EHS).
• A highly motivated individual with a keen interest in operation support.
• Proven self-motivation and direction with a continuous improvement mindset.
• Demonstrated ability to lead and realize improvement initiatives successfully.
• A track record of success in a team-oriented environment.
• Excellent technical writing skills, ensuring clarity, conciseness, and accuracy while effectively communicating complex information.
• Strong engagement skills with shop floor personnel to ensure completion of actions