The Quality Control (QC) Supervisor will work with the Quality Manager as a senior member of the Quality department to facilitate the use of SERB’s Quality Management Systems (QMS), release product and related consumables to ensure adequate supply for export. You will manage the QC team to ensure all required sampling is performed and to deliver agreed testing output to the supply chain and work with the Australian Leadership Team (ALT) to deliver those production requirements to the required cost, quality and time targets.

Principle Responsibilities

Product Release

Review all completed documentation to determine disposition of serum. Verify product conformance to specifications and evaluate any Quality Events / Deviations, Out of Specification (OOS) Results, Sheep Health Reports, QC testing and Environmental Monitoring data for the release of serum.

Ensuring serum (API raw material) adheres to all relevant standards.

Compliance and Support

Provide strong leadership to the QC team whilst role modelling SERBs values.

As a senior member of the Quality department, you will be required to lead by example in delivering SERB’s objectives through communication, consistency, and demonstrating the SERB’s values whilst building relationships within the company.

Ensure the QMS as described in the Organisation’s Quality Policy is complied with at SERB Pharmaceuticals

Conduct GMP audits internally and externally to ensure compliance with TGA, FDA and any other relevant Regulatory Authority.

Ensure that we continuously review key quality parameters through quarterly trending of QC testing results and CAPA programme to implement Continuous Improvement to Quality.

Ensure there is a system for storage of batch reference samples as required by Regulatory Authorities.

Evaluate Quality and GMP related incidents through a CAPA programme.

Assist Quality Manager to ensure Australian sites comply with GMP as recommended by the TGA, FDA and other relevant Regulatory Authorities. The QC Supervisor is expected to advise the team on GMP compliance, particularly in relation to QC matters.

Support the business to develop a competency-based training program for QC department.

To maintain, review and approve documentation including specifications, procedures, test methods, plans, schedules, records and validation documentation in compliance with GMP and company requirements.

To develop laboratory test methods, generate validation plans, protocols and reports for the methods and execute test method validations as required.

Be able to identify and change procedures, which are inconsistent or unworkable with the guidance of the Department Manager and in relation to TGA and FDA compliance.

Review all completed documentation to determine disposition of serum. Verify product conformance to specifications and evaluate any Quality Events / Deviations, OOS Results, Sheep Health Reports, QC testing and Environmental Monitoring data for the release of serum.

Manage the response to OOS results, ensuring that company procedures are followed and investigations are thorough and timely.

Ensuring serum (API raw material) adheres to all relevant standards.

The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

Education and Experience

A Degree or equivalent in a scientific discipline such as Chemistry, Biochemistry, Microbiology, Immunology, Pharmacy or Life Science.

Previous experience in a senior quality role, preferably within the Pharmaceutical/Biotechnology industry.

Educational background should be supported by at least 5 years’ experience in an appropriate Quality role within the Pharmaceutical / Biotechnology industry.

In depth knowledge of GMP.

Ability to conduct self-inspection audits

Literacy, numeracy and good keyboard skills are imperative

Proficient IT skills particularly in Excel and Word

Skills and Attributes

Confident with the ability to work with employees at all levels of seniority utilising excellent communication skills, both on an internal and external basis.

Competent, methodical, highly organised individual who pays strict attention to detail and has the ability to effectively prioritise and execute tasks accurately within a high-pressure environment.

Organisational skills should be strong with an ability to plan ahead.

Creative thinker able to solve problems, question the status quo and consider innovative solutions to complex issues.

Must be able to work as part of a collaborative team and demonstrate initiative when required with a flexible and willing attitude at all times.

Strong written and oral communication skills.

Highly self-motivated and directed.

Compliance

Responsible for the timely completion of the QC departments’ QMS actions.

Relevant audits (internal and external) completed to approved plan for rolling 12 months (any exceptions documented and risk assessed)

Responsible for the timely completion of validation actions in QC department and/or other departments dependent on critical requirements

Ensure all HR and EHS action requirements are completed within timelines set