Associate Director, Product Owner - Time & Absence

- To assist the Analytical Chemist / Microbiologist to ensure that all utilities (water, environmental and compressed gas), process raw materials, factory samples, intermediates and final products are analysed and the results recorded in full compliance with current Good Manufacturing Practice (cGMP) and regulatory requirements that meets the defined quality standards.

- In addition, provide analytical support for non-order fulfilment activities required for the resolution of process and method problems / issues, and the introduction of new measurement technologies and analytical tests.

- To lead, schedule and test Value Stream specific raw materials, process intermediates, final product, non-routine samples and ENVOPS in accordance to written procedures and methods.

Key Responsibilities

1. Ensure that all raw materials / factory samples / intermediates / final products / utilities microbiological monitoring / non-order fulfillment and NCE fulfillment activities are analyzed and tested according to the stipulated quality requirements so as to provide accurate test results for correct usage decisions.

2. Ensure that all instruments are in positive working order, reagents and reference standards within expiry and that documents meet regulatory standards.

3. Operate the relevant computer applications that are related to the laboratory functions, such as Corporate ERP System, LIMS, Empower and other network operating systems, as required to ensure completion of Corporate ERP System transactions.

- Use the appropriate documentation system for the activities being carried out
- Ensure training records keep up to date.

4.



Maintain an excellent standard of housekeeping in the laboratory.

5. Ensure a safe working environment in the laboratory and perform 6S inspection.

Key Requirement

- GCE 'O' or 'A' Level in relevant subjects and/or Diploma in Chemical Process Technology or Applied Chemistry
- Minimum 2 years of experience in an analytical environment, preferably in the pharmaceutical industry
- Open to fresh graduates
- Must be open to 12-hour shift work pattern
- Good knowledge of GMP and GLP
- Good knowledge of analytical techniques, equipment capabilities and operational needs
- Good knowledge of microbiological testing
- Understanding product specification and method of analysis
- Knowledge of laboratory instrumentation
- CDS, LIMS and Corporate ERP System knowledge
- Good teamwork
- People management skills (SLA and SLA3)

Skills

Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Quality Assurance (QA), Quality Control (QC), Risk Awareness, Testing Operations

Job Purpose

- To assist the Analytical Chemist / Microbiologist to ensure that all utilities (water, environmental and compressed gas), process raw materials, factory samples, intermediates and final products are analysed and the results recorded in full compliance with current Good Manufacturing Practice (cGMP)



and regulatory requirements that meets the defined quality standards.

- In addition, provide analytical support for non-order fulfilment activities required for the resolution of process and method problems / issues, and the introduction of new measurement technologies and analytical tests.

- To lead, schedule and test Value Stream specific raw materials, process intermediates, final product, non-routine samples and ENVOPS in accordance to written procedures and methods.

Key Responsibilities

1. Ensure that all raw materials / factory samples / intermediates / final products / utilities microbiological monitoring / non-order fulfillment and NCE fulfillment activities are analyzed and tested according to the stipulated quality requirements so as to provide accurate test results for correct usage decisions.

2. Ensure that all instruments are in good working order, reagents and reference standards within expiry and that documents meet regulatory standards.

3. Operate the relevant computer applications that are related to the laboratory functions, such as Corporate ERP System, LIMS, Empower and other network operating systems, as required to ensure completion of Corporate ERP System transactions.

- Use the appropriate documentation system for the activities being carried out
- Ensure training records keep up to date.

4. Maintain an excellent standard of housekeeping in the laboratory.

5. Ensure a safe working environment in the laboratory and perform 6S inspection.

Key Requirement

- GCE 'O' or 'A' Level in relevant subjects and/or Diploma in Chemical Process Technology or App

📌 Medical Business Associate (Sydney)
🏢 Gsk
📍 Sydney