Assoc. Spclst, Operations (1 Year Contract)

MSD INTERNATIONAL GMBH (SINGAPORE BRANCH); Singapore; Sur place; SGD 39 000 - 61 000; Plein temps

Résumé du poste

MSD INTERNATIONAL GMBH (SINGAPORE BRANCH) seeks an Operation Support Specialist to coordinate manufacturing documentation and play a key role in SAP/MES operations. You will support batch records, SOP updates, and change controls while collaborating with GTO/Process Engineering, Quality and SHE teams.

The role emphasizes documentation accuracy, regulatory compliance and continuous improvement, with a 1-year fixed contract in a GMP environment. Strong communication and teamwork are essential.

Qualifications

• Diploma or degree in engineering with GMP knowledge.
• Experience in documentation preparation, control and review.
• Familiarity with cGMP guidelines and regulatory expectations.

Responsabilités

• Coordinate and review manufacturing batch documentation per cgMP.
• Maintain filing and safekeeping of manufacturing documents.
• Lead improvement initiatives for document accuracy and process flow.
• Act as SAP Super-User for inventory updates, PO releases and DO postings.
• Support CI activities with Lean Six Sigma tools and standard work.

Connaissances

Documentation control

Regulatory compliance

Quality systems

Communication skills

Formation

Engineering diploma/degree

Outils

SAP

MES

Description du poste

The Operation Support Specialist coordinates and supports all manufacturing related activities for the Integrated Process Team (IPT). These activities include:

• Assist the Production Supervisors in the allocation of resources to meet agreed production plan (through weekly Planning meetings) and prioritize any other shop floor ad-hoc activities.
• Assist Production supervisor in management of compliance and coordination of technical skills training for shopfloor staff
• Complete post-manufacturing batch documentation review and lead initiatives to improve straight-through documentation.
• Act as the IPT SAP Super-User; coordinates SAP shutdown maintenance, supports all SAP inventory updates and reversals, release Process Order (PO) and perform Good receipt Delivery Order (DO) into SAP.
• Data collection for APR, Profit planning and management of Tier process.
• Prepare and issue necessary documents for production use. These documents are the batch records, manufacturing labels and other essential documentation related for production such as SOPs and Job Aids.
• Lead the change executions for manufacturing documentation in liaise with other departments in Pharm such as GTO/Process Engineering, Quality and Manufacturing. This includes emergency changes related to the batch documentation when needed.
• Supports development of a continuous improvement framework within the overall IPT improvement program.
• Processing of POs for non-BOM items to support IPT operations

MAIN RESPONSBILITIES

1. Manufacturing Excellence
   • Prepare and issue necessary documents in a timely manner for manufacturing use.
   • Support document revision (SOP, Forms, etc) when necessary to improve the system of documentation review, issuance and preparation.
   • Completes manufacturing batch record review in accordance with cGMP requirements.
   • Maintains proper filing and safe keeping of all relevant manufacturing documents and have them available when needed
   • Provide straight-through document accuracy metrics and lead associated improvement initiatives
   • SAP & MES User and Inventory Updates
   • Update BOMs for Pharm West products
   • Test script execution for MES changes to MBR
   • Ensure SAP inventory accuracy and support manufacturing-related stock adjustments and/or reversals
   • Management of Manufacturing Aids and Consumables
   • Create, release and close PO for products
   • Others
   • Data collection and metric tracking to support Tier process
   • Update APR and CPV for nominated Pharm West products
2. Continuous Improvement (CI)
   • Utilizes Lean Six Sigma Tools (Six Sigma, Kaizen, SMED, 5S etc) to support execution of continuous improvement projects to increase agility, flow, throughput and reduce cycle time and inventory
   • Initiate Continuous Improvement (CI) activities in area of responsibility - Batch document simplification, SOP & JA process review etc.
3. Quality
   • Ensure that all assigned tasks related to manufacturing documentation support is in accordance with good manufacturing practices.
   • Prepare or update SOPs and related documents to ensure compliance with regulatory standards.
   • Actively engage in audits and support implementation of agreed follow-up actions.
4. Safety, Health & Environment (SHE)
   • Ensure that all assigned daily manufacturing activities are planned and carried out in accordance to SHE requirements
   • Participate in (as required) and support the implementation of actions for all incidents investigations and audits
   • Ensure all regulatory permit requirements are met for IPT maintenance activities Promote SHE leadership behaviours and engage employees at all levels on SHE issues
   • Ensure incident investigations and audits are fully supported with improvement actions implemented
5. People Excellence
   • Self
   • Resilient and resourceful
   • Continuous learning mindset
   • Foster teamwork and cross collaboration
   • Strong work ethics
   • Effective communication skills

Qualification:

• Diploma or Degree in Engineering (Chemical, Mechanical or Electrical), Science or a related discipline
• 3-4 years (preferred) in an operations environment with experience in documentation preparation and control preferred
• Good knowledge in applicable regulations and GMP policies/guidelines (especially Cleaning/Housekeeping/Maintenance, Environmental Control, Process/Cleaning/ Equipment Validation, Change Control and Manufacturing Practices)
• Good stewardship awareness (including cGMP, regulatory inspection preparation, SHE)

This is a fixed 1-year contract role.

WHAT YOU CAN EXPECT

• Limitless opportunities across various areas in Manufacturing; well-structured career path
• A state-of-the-art facility that delivers solution to its customers world-wide
• Highly engaging team that aims to innovate the future