Assoc. Spclst, Operations (1 Year Contract)

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

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 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