Lab Manager (QC Manager)

Pharma - Contract Manufacturer; Sydney; On-site; AUD 120,000 - 150,000; Full time

Job summary

Pharma - Contract Manufacturer in Smithfield NSW is seeking an experienced Lab Manager to lead analytical operations. The role requires hands-on expertise with HPLC and other techniques, plus extensive experience in method development and validation.

You will train staff, ensure GMP/GLP compliance, manage lab audits, and drive quality control from raw materials to finished products, while maintaining accurate documentation and instrument calibration.

Qualifications

• 7+ years hands-on experience with HPLC and other analytical techniques.
• Experience in method development and validation for raw materials and finished products.
• Proven ability to train staff and ensure GMP/GLP compliance.

Responsibilities

• Perform QC assignments including raw material, in-process and finished product testing.
• Create and update QC documents, specifications and test methods.
• Train staff and ensure compliance with regulatory requirements.
• Manage lab and handle regulatory audits.
• Develop and validate analytical methods for materials and products.

Skills

Lab management

HPLC

Analytical method development

Regulatory compliance

GMP/GLP

Tools

GC

FTIR

UV-Vis

ICP-OES

Job description

Pharma - Contract Manufacturer – Smithfield NSW

A growing pharmaceutical company has vacancyfor an experienced Lab Manager. This is a role for analysts with minimum 7 years hands-on experience with HPLC and other analytical techniques and substantial experience in analytical method development and validation.

Primary Objectives

Performprofessional quality control analyst assignments, including raw material testing, in-process testing and finished product testing using various analytical techniques and instruments (HPLC, GC, FTIR, UV-VIS, ICP-OES, etc)

Creating and updating QC Documents, including specifications and test methods, as required

Train staff and ensure compliance with regulatory requirements

Manage lab and handle regulatory audits

Develop and validate analytical methods for raw material and finished products

Job Description

Perform laboratory analysis of raw materials, finished goods and other samples using analytical instruments and analytical techniques

Prepare and label laboratory reagents, reference standards and solutions according to SOPs.

Record the results on the analytical report.

Order laboratory standards, chemicals and solvents.

Calibrate analytical instrument, as and when required.

Comply with GMP and GLP.

Follow safety procedures when working in laboratory.

Maintain the laboratory in an organized and neat manner

Assist in investigation of any OOS

Provide training to junior staff

Handle day to day operations of lab

Ensure compliance and Handle regulatory audits