Position Summary:
The role of the Quality Assurance Officer - QMS, Products is to:
- Perform QA activities to support the quality system and ensure all activities meet GMP guidelines, NID regulations and ISO Standards.
- Carry out sampling and testing in accordance with the Quality System and GNIP regulations.
- A tertiary qualification in a relevant scientific discipline or equivalent, with a minimum of 1-year experience in a GB P/ ISO certified environment.
Key Responsibilities / Authorities:
OC Sampling & Testing:
- The Quality Assurance Officer will carry out sampling and testing according to standard operating procedures.
- Ensure all activities meet GMP and ISO guidelines as specified by FCC quality system and training.
- Ensure all activities are carried out in a safe manner and according to Workplace Health and Safety regulations.
- Sampling and testing of packaging materials, raw materials, intermediate products and finished products to verify they meet specifications.
- Assist production staff in relation to any information or guidance required for quality issues in conjunction with Laboratory management.
- Ensure compliance for laboratory activities undertaken within FMC guidelines.
- Send samples to approved contract testing laboratories.
- Preparation of solutions and reference standards.
- Approve all chemical reagents before use.
- Check the calibration status of all laboratory equipment before use. Ensure that all laboratory equipment is calibrated as per the calibration schedule.
- Ensure laboratory data is recorded on the appropriate registers.
- Perform stability testing on haemodialysis solutions as per the stability studies schedule.
- Maintain orderly storage of retention samples.
- Notify the QA Manager / Lab Supervisor of any discrepancies or out of specification results inn mediately.
- Only approve products for further processing that test within specification.
- Ensure the lab supervisor is advised of any low stock materials used in the laboratory including chemicals and glassware.
- Ensure that all data is recorded on the correct forms in real time.
- Ensure that changes to any recorded data are only made in the correct manner and signed and dated as per training.
- Assist in internal audits for compliance with FMC quality systems.
- Carry out other projects as directed by the Quality Assurance Manager/ Laboratory Supervisor.
Ouality Management Systems:
- Assist in the developmentand maintenanceof QualitySystems and provide support and guidanceto ensure compliancewithapplicablestandards.
- Assist with Non-conformance and Deviation Management. Ensure corrective / preventative actions are taken and are effectively implemented.
- Review and maintain specifications, standard operating procedures and other quality documents.
- Work closely with other departments to ensure staffs are working in compliance with internal policies and procedures.
- Assist with the development and implementation of QA process improvements.
- Ensure all activities are carried out in a safe manner and according to Work, Health and Safety regulations.
- Assist in internal audits for compliance with FMC quality systems.
- Assist in introduction of global documents, policies for effective implementation on site
- Carry out other projects as directed by the Sr Quality Assurance Manager.
Business Expansion / Product Introduction:
- Assist Sr QA associate in establishing quality plans and related activities for Smithfield.
- Assist Sr QA associate in managing site QMS effectively, ensure ISO and EU MDR certification is maintained during project roll overs.
- EnsureQA/productcompliancemaintainedfor Smithfieldproductprofile (both Smartbags and ProcedurePacks)
Description of Qualification, Key Skills, Personal Attributes:
- A tertiary qualification in a relevant scientific discipline or equivalent.
- Minimum 1-year experience in a GMP, Medical Devices and/or ISO certified environment.
- Excellent written and verbal communication skills.
- Ability to manage a hig h throughput of work while meeting quality and business requirements and deadlines by having excellent organisational skills.
- Computer literacy.
- Good English Literacy and numerical skills.
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Quality Assurance Officer in Sydney employer: Fresenius Medical Care
Fresenius Medical Care is an exceptional employer, offering a dynamic work environment that fosters professional growth and collaboration. As a Clinical Sales Specialist, you will benefit from comprehensive training programs, a supportive team culture, and opportunities to engage with key opinion leaders in the healthcare sector, all while making a meaningful impact on patient care in your region. With a commitment to employee development and a focus on innovative solutions, Fresenius Medical Care stands out as a rewarding place to build your career.
