SERB Specialty Pharmaceuticals QA Officer – Apply Now
SERB Specialty Pharmaceuticals is a global specialty pharmaceutical group focused on prescription medicines which address rare and life-threatening diseases. Following strategic acquisitions and targeted developments, SERB has succeeded in establishing a consistent drugs portfolio focused on niche specialty pharmaceuticals to ensure continuous availability of life-saving medicines and answer unmet medical needs. Our commitment is to continue to offer essential drugs meeting Public health needs.
Job Posting: QA Officer
Date: Dec 11, 2024
Location: Gawler Region – Turretfield
Company: SERB
Current Opportunity
About Serb Pharmaceuticals
Serb Pharmaceuticals provides rescue medicines typically used in emergency rooms and intensive care units to treat patients for whom there are limited treatment options. We are dedicated to delivering quality medicines that make a real difference to patients and their families through the development, manufacture, and commercialisation of pharmaceutical products.
Broad Function
To be aware of and follow Serbโs Quality Policy. To provide support in the management of Quality System and eDMS (Proquis and ComplianceWire). Assist the Quality Manager and the Quality Department across both Turretfield and Martindale sites in all areas of the Quality System. To support personnel at all levels in the understanding and implementation of Quality System, documentation, and its effectiveness.
Principle Responsibilities
- Issue manufacturing records for immunizing, bleeding, and serum production in accordance with prepared schedules.
- Reconcile all manufacturing records when returned to QA.
- Review and audit manufacturing records and processes for compliance with SOPs and GMP requirements.
- Ensure deviations, CAPA, and other discrepancies related to batches are reconciled and investigations closed out in a timely fashion.
- Assist departments in the creation of training curriculums and documentation.
- Represent QA for discussion of CAPA incidents, risk assessment, and agreement on corrective and preventive actions.
- To perform and participate in internal and external audits as required according to the audit schedule.
Education and Experience
An educational background in Biological Analytical Science is preferred (i.e. Microbiology, Biotechnology, Chemistry, Biochemistry, and Immunology). Previous experience in a Quality Assurance role is preferred but not essential. Previous experience in a regulated industry, ideally a GMP environment is preferred but not essential.
Skills and Attributes
- Literacy, numeracy, and good keyboard skills are imperative.
- Proficient IT skills particularly in Excel and Word.
- Confident with the ability to work with employees at all levels of seniority utilizing excellent communication skills, both on an internal and external basis.
Must be able to work as part of a team and demonstrate initiative when required with a flexible and willing attitude at all times.
Apply for this position here
Keywords: QA Officer, SERB Specialty Pharmaceuticals, Quality Assurance, Pharmaceutical, GMP, Biological Analytical Science. SERB Specialty Pharmaceuticals QA Officer – Apply Now