Activ Pharmaceuticals – Smeaton Grange NSW
Activ Pharmaceuticals, based in Smeaton Grange, manufactures liquid and cream products in cosmetic and therapeutic grades and is a part of the Activ Pharmaceuticals Group.
We are now looking to a Quality Control Chemist to join our dynamic team.
Essential Criteria are as follows:
- Minimum 3 years' experience working in a GLP/GMP Quality Control environment, with a strong understanding of the Code of GMP and its application within a laboratory setting.
- Demonstrated experience performing analysis and formal release of starting materials, bulk products, and finished products in a timely manner.
- Experience using pharmaceutical compendia such as BP, USP, and other relevant standards.
- Minimum 3 years' hands‐on experience with GC, HPLC, IR, UV, and potentiometric analytical techniques, including troubleshooting and method optimisation.
- Proven experience in analytical method validation in accordance with regulatory and industry requirements.
- Experience performing laboratory equipment calibration, qualification, and ongoing performance verification activities.
- Experience providing training and technical guidance on the operation, care, maintenance, and troubleshooting of HPLC, GC, and other laboratory instruments.
- Bachelor of Science (Chemistry) or a closely related scientific discipline.
Duties of this position will include:
- Performing OOS, OOT and OOE investigations and root cause analysis.
- Providing technical support to Management (e.g., summarised QC data, trend records etc).
- Providing analytical support to the product development department and stability program.
- Maintenance of all QC records, including notebooks and equipment logbooks in accordance with GLP/GMP requirements.
- Reviewing Supplier/Manufacturer CoAs, supply chain records and other QC documentation.
- Performing reference solution standardisation.
The successful candidate should also possess the following:
- Ability to work independently or as part of a team.
- Have a sound understanding of data integrity requirements in the laboratory.
In return, Activ Pharmaceuticals will offer:
- An immediate start working a 38-hour week with a 2.30pm finish on a Friday.
- An equitable and ethical workplace.
- The support of a professional team working in a safe environment.
