Assoc. Spclst, Operations

Merck; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Merck Singapore is seeking an Operations Support Specialist to coordinate and support all manufacturing activities for the DPI Integrated Process Team (IPT). You will help allocate resources, review post-manufacturing batch documentation, and act as SAP Super-User for inventory and PO workflows.

You will contribute to continuous improvement within the IPT, develop manufacturing documents such as batch records and SOPs, and ensure compliance with cGMP, SHE, and regulatory standards through robust

Qualifications

• Diploma or Degree in Engineering or related discipline; experience/technical skills
• 2-3 years (preferred) in an operations environment with documentation preparation and control
• Good knowledge of applicable regulations and GMP 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)

Responsibilities

• Coordinate and support all manufacturing documentation and batch records.
• Lead batch documentation reviews and drive straight-through documentation improvements.
• Act as SAP Super-User; manage SAP inventory, stock adjustments, and PO processing.
• Contribute to Continuous Improvement (CI) initiatives within the IPT.
• Ensure manufacturing documentation complies with GMP and SHE requirements.

Skills

Analytical Problem Solving

Audit Processes

Change Management

Documentation Preparation

Documentation Review

Document Management

GMP

Production Planning

Production Scheduling

Process Optimization

Education

Engineering degree

Job description

Job Description

The Operation Support Specialist coordinates and supports all manufacturing related activities for the DPI 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.
• 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 PO and perform Good receipt delivery order into SAP.
• Data collection for Annual Product Review, Profit planning and management of Tier process.
• Prepare and issue necessary documents for production use. These documents include 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 DPI such as Technical (PTO)/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 Purchase Orders 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

Batch Documentation Reviews

• Complete post-manufacturing batch documentation reviews
• Provide straight-through document accuracy metrics and lead associated improvement initiatives

SAP & MES User and Inventory Updates

• Update BOMs for DPI 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 Purchase Orders for consumables

Others

• Data collection and metric tracking to support Tier process
• Update Annual Product Reviews for DPI products
• Any other tasks as and when assigned by manager

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 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
• Promote SHE leadership behaviors and engage employees at all levels on SHE issues
• Ensure incident investigations and audits are fully supported with improvement actions implemented

WHAT YOU MUST HAVE

To be successful in this role, you will have:

• Diploma or Degree in Engineering (Chemical, Mechanical or Electrical), Science or a related discipline) Experience/Technical Skills:
• 2-3 years (preferred) in an operations environment with experience in documentation preparation and control preferred
• Good knowledge in applicable regulations and GMP 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)

Required Skills:

• Analytical Problem Solving
• Analytical Problem Solving
• Audit Processes
• Change Management
• Documentation Preparation
• Documentation Review
• Document Management
• Equipment Maintenance
• Equipment Set Up
• Focused Improvement
• Good Manufacturing Practices (GMP)
• Leadership Theories
• Machinery Operation
• Manufacturing
• Manufacturing Analytics
• Manufacturing Operations
• Metrics Development
• Process Improvements
• Process Optimization
• Production Planning
• Production Scheduling
• Production Sound Recording
• Product Ordering
• Project Management
• Raw Material Specifications {+ 8 more}