AddressCome and Save Lives with Us!
The Company is a growing international specialty pharmaceutical group that is a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases. We have over 400 employees in 16 countries.
Our portfolio 80+ rescue medicines make a real difference in the lives of patients and their caregivers and that gives every one of our employees a sense of purpose.
Our Purpose is supported by our 4 key values:
- We make patients our priority
- We act with integrity and accountability
- We work together as one team
- We look for better ways forward
Broad Function
The QA Supervisor will work with the Quality Manager, and act as part of the Australian Operation Leadership Team (AOLT) to facilitate the use of BTG’s Quality Management Systems (QMS), release product to ensure adequate supply for export. You will manage the QA team to deliver agreed targets for the global QMS and work with the Australian Leadership Team (ALT) to deliver those production requirements to the required 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 Non-Conformances, Out of Specification 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
- Ensure the QMS as described in the Organisation’s Quality Policy is complied with at all times
- Issue manufacturing records for immunising, bleeding and serum production in accordance with prepared schedules
- Ensure CAPA review board and CCRB meetings are organised every week and lead by QA Supervisor
- Represent QA for discussion of Quality Event (QE) and CAPA incidents, Quality Risk Assessment and required root cause analysis and agreement on corrective and/or preventive actions
- Conduct GLP/GMP audits internally and externally to ensure compliance with TGA and FDA and any other relevant Regulatory Authority
- Audit Sheep Health Reports and associated records to ensure records are complete, accurate and fulfil requirements of SOPs and regulatory requirements. Ensure discrepancies are reconciled and investigations closed out in timely manner.
- Ensure that we continuously review trending of QMS to implement Continuous Improvement to Quality systems.
- Evaluate Quality and GMP related incidents through a CAPA programme
- Assist Quality Manager to ensure Australian sites comply with Good Manufacturing Practices as recommended by the TGA, MHRA and FDA and wherever possible advise on compliance.
- Support the business to develop a competency-based training program for QA 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.
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 highly desirable
- 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 cGMP
- Ability to conduct self-audits
- 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
Company Benefits
- Employee Assistance Program
- Annual Performance Related Bonus
- Salary Sacrifice Options
- 5 weeks of Annual Leave with additional Christmas Leave
Please head to careers.serb.com to apply
