Quality Assurance Manager

Victoria
Full Time

08/09/2022

CLIENT

Based in Melbourne’s South Eastern suburbs and with 60+ years of experience in product development and manufacturing, our client sets the standard in reliability and quality. Partnering with their clients’ businesses, they ensure the security of supply through high-quality manufacturing and on-time delivery. Their focus is on contract manufacturing of listed and over-the-counter (OTC) therapeutics. This has enabled them to provide a high level of service to many high-profile clients, national and international, and has been a major factor in their continued growth.

Operating over two sites in excess of 18 acres and an annual output of 70 million units, our client specialises in the contract manufacture of Therapeutics (prescription, OTC, and complementary medicines), Medical Devices, and Personal Care products.

WHAT’S IN IT FOR YOU?

On offer are a competitive salary package, excellent work conditions and friendly environment, positive work-life balance and on-site parking.

Our client is an Australian Company where decisions are made in real-time. They have had exponential marketplace growth in the last 5 years.

ROLE 

Reporting to the Managing Director, the QA Manager role is to develop, review, improve and implement policies, programs and Master Files to uphold the Quality Function. To ensure that the Company’s activities are in compliance with current legislations, standards, regulatory bodies and internal policy and procedures, promoting best practices.

With 6 direct reports, the QA Manager will also manage and oversee the training and development of the entire Quality Team. The Quality Team compromises of QA, QC Laboratory and Microbiology staff.

RESPONSIBILITIES

Some of the responsibilities associated with this role include:

• Act as Company Representative, as required by the relevant Standards

• Review and take action on all Status Reports received, for current production operations

• Manage the new supplier approval process, and co-ordinate supplier assessments and/or audits

• Oversight of validation activities and the stability programme for the facility

• Manage the review and audit of productions procedure programme and documentation

• Act as Authority for release of product, release for supply/sale

• Investigate Incident / Deviations Reports and initiate CAPAs

• Oversight of the preparation of specifications, test methods, quality documents incident/deviations reports, CAPAs and master batch documents

• Initiate and maintain GMP contracts with customers

• Manage the Product Quality Review process, change control process, medical Device technical files

• Oversee and finalise risk assessment processes involving product released for supply

• Review and update the site QA Programs including the Site Master File

• Establish acceptance testing criteria and practical sampling schemes

SELECTION CRITERIA

To be considered for this opportunity you must meet the following criteria:

• Minimum of a Bachelor’s Degree in Chemistry, or similar

• At least 5-8 years of Quality Manager experience, managing QA and QC functions in a manufacturing facility, i.e. pharmaceutical, food or cosmetics manufacturing

• TGA auditing experience in a GMP facility – internal audit preparations and hosting of external audits

• Excellent verbal and written communication skills

• Proven experience managing QA and QC teams, and excellent people management skills

• Strong ability to build professional relationships with internal and external stakeholders

• Strong ability to problem solve, and make decisions that uphold the Company Strategic Objectives

• Good work ethic, excellent interpersonal skills, and a good team player is a must!

APPLICATION

To have a confidential discussion about this role, please contact Daniele on 0434 746 *** or Jo on 0411 197 ***.

Alternatively, if you feel you have all the information you need, click the ‘Apply’ button to commence your application by submitting both a Resume and Cover Letter (MS Word format is preferred).

THANK YOU

Given we appreciate the effort it requires to express an interest in response to a job advert, CS Executive Group thanks you in advance for your time in applying for this role. Unfortunately, due to the large volume of applications we receive daily, we typically only contact individuals who we consider as having suitable qualifications and experience to be assessed further for shortlisting.

Nevertheless, if on this occasion you’re unsuccessful, please note your details will be added to our Talent Pool database—you might therefore be contacted by us for suitable roles arising in the future.

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