Quality Control
Vor 2 Tagen
Quality Control (QC) Operations Supervisor Phebra Pty Ltd develops, manufactures, and supplies high quality and innovative pharmaceuticals to meet the requirements of the hospital specialty pharmaceutical market.
At Phebra, we create critical medicines which save and improve lives.
For more information about Phebra, please visit our website www.phebra.com.
Working with Phebra, you will have an opportunity to contribute and make a difference
Our head office and manufacturing facility is based in Lane Cove, Sydney.
The location holds our manufacturing site, microbiological and QC laboratory facilities, warehouse, and office environments.
The QC Operations Supervisor role is a permanent full-time opportunity which has come about due to an internal move of the current incumbent to a new role within the company.
The QC Operations Supervisor role will be situated on-site at our facility in Lane Cove, reporting to our QC Manager and has responsibility for a small team of 3 QC Laboratory Analysts and 1 QC Lab Assistant, as well as managing other key internal and external stakeholder relationships.
The primary role of QC Operations Supervisor at Phebra is to oversee the administration of the company's daily quality control operations within the areas of laboratory testing and sampling relating to our manufacturing processes.
The functions of the role are skilled and of a technical nature which requires scientific knowledge and experience around sterile manufacturing and experience within the technical aspects of cGMP, analytical and microbiological tests, stability guidelines, and an integrated quality management system.
The position will involve, but not be limited to, the following duties:
Coordination of testing throughout the manufacturing process to maximize efficiency while maintaining quality standards.Reviewing testing results and compliance with specifications and limits.Initiate, coordinate, and review laboratory investigations for OOS and OOT results ensuring root cause analysis is conducted where required.Release or reject raw materials, primary and secondary components, and consumables based on analytical and physical measurements.Coordinate the sampling, testing, and reporting of WFI, including any additional testing required for investigation of any PPS results, completed in coordination with QC Microbiologists.Management and coordination of all testing with contract laboratories for finished product and raw materials.Management and coordination for all retention samples.Generation of finished product Certificate of Analysis for each batch that will act as part of evidence for release for supply.Line management responsibility for direct reports including maintaining training compliance, providing guidance, and completion of performance reviews for reports.Who are we looking for? Our ideal candidate would be someone who can think outside of the box, be pragmatic and solutions-oriented while remaining agile and flexible in approach as well as having the following requirements:
Minimum degree qualification in a Chemistry-related discipline.Experience (5+ years) within pharmaceutical manufacturing including time spent within QC Laboratory.
Sterile manufacturing experience preferred.Good knowledge and ability to interpret micro and chemistry test results.Excellent knowledge in Chemistry Manufacturing and Controls (CMC).Experience with technical aspects of GMP / GLP / Stability programs.Ability to drive company business process improvements for the department.Strong technical writing skills.Strong communication skills across multiple types of internal / external stakeholders.Full working rights in Australia is essential – if you have a temporary visa, please address subclass and expiry during your application.What do you get? We offer a competitive base salary depending on level of experience and suitability with the above requirements.
Additional employee benefits include: Annual discretionary bonus, based on individual and company performance.Training and development opportunities.Novated lease administration options.Free parking at work.Access to annual flu vaccinations.If the above role sounds like something you may enjoy, and you would like to apply, please send through a resume and cover letter by clicking on "apply now" and our People & Culture Manager, Kelly Lawrence, will be in contact to discuss your application should your application meet our requirements and be shortlisted.
Please note all applications will not be reviewed until the 6th of January when we return after the New Year.
Phebra is an equal opportunities employer; we are committed to diversity and inclusion within the workplace and believe that a diverse team with unique perspectives, ideas, and experiences should be valued.
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