AddressPhebra 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 Senior Analyst role is a permanent full-time opportunity which falls within our Quality Control team working onsite at Lane Cove, Sydney. The role of QC Senior Analyst at Phebra is related to testing of raw materials, packaging components and finished products for release and use within our manufacturing processes, and to provide support for training of staff and implementation of equipment and software within the onsite lab. The role also assists Supervisors with scheduling of testing and troubleshooting.
The functions of the role are skilled and of a technical nature which requires scientific knowledge and experience around pharmaceutical manufacturing (sterile preferred) and experience within the technical aspects of cGMP, Quality Control testing, and working with an integrated quality management system.
The position will involve, but not be limited to, the following duties:
- Analysis of finished products and raw materials including a range of analytical technique such as chromatographic spectroscopic, potentiometric, physical and wet chemistry.
- Assist with implementation of procedures for complex laboratory software’s as per CSV and CFR policies including Empower3
- Assist with implementation of new laboratory equipment contributing to drafting, executing IQOQPQ qualification and drafting SOPs for operational, CSV and administration of the equipment.
- Draft, review and execute method transfer protocols, as part of method transfer program.
- Review testing results for compliance with specification and limits
- Collation of test results – including results from external labs – and data trending.
- Handling of s8 materials as per applicable Department of Health Legislation.
- Participate in Change Control activities, OOS/OOT investigations as and when required.
- Participation in laboratory projects as required.
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 Chemistry related discipline
- Experience (4+ years) within pharmaceutical manufacturing. Sterile manufacturing experience preferred.
- Experience within QC Laboratory with raw material and finished product testing.
- Good knowledge and ability to interpret test results
- Knowledge in Chemistry Manufacturing and Controls (CMC)
- Experience with technical aspects of GMP/GLP
- 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.
- Annual paid volunteer day.
- 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.
Phebra are 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.
