Join Rexpharma and be part of a team dedicated to delivering quality certification and QP support for clinical and biological products
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Explore our current job openings and find out how you can contribute to our mission of pioneering pharmaceutical services.
This is a part-time contract Quality Specialist role reporting to the Chief Technical Officer. The Quality Specialist is required to be a self-starter and demonstrate a high degree of independence and professionalism in this client- facing role. The Quality Specialist will be responsible for implementation, maintenance, and execution of the Rexpharma Documentation System (RDS) and the Pharmaceutical Quality System (PQS).
The Quality Specialist shall write and maintain SOPs and policies for the company. They will execute the QMR and metrics systems, manage suppler change notifications, deviations, CAPAs, meetings, archival duties, and support audits and regulatory inspections. The role will support regulatory activities at Rexpharma and on behalf of clients to ensure established quality standards and regulatory requirements are maintained. The Quality Specialist shall support the QP in the batch review, QP batch certification, and disposition of clients batches. They shall write quality agreements and manage client and supplier interfaces on behalf of Rexpharma.
The working arrangements are very flexible and focused on results. Rexpharma is committed to accommodating a healthy work-life balance and it is expected that this role is suitable for individuals that have taken a break from work and are looking to get back into an exciting quality role on a part-time basis.
This is a contract role for a minimum of 12 months, with extension desirable. The location for this role is hybrid, with the work being performed partially onsite and (mostly) offsite. It is anticipated that this role will require limited, infrequent travel.
The individual may be responsible for, but is not limited to:
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Assist in establishing, organising, and maintaining the PQS.
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Issuance of QMR reports, change controls, deviations, CAPAs, monthly metrics, and quality agreements.
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Maintain oversight of clients and suppliers by establishing the management framework, issuance of product specification files, and meeting minutes.
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Assist in establishing, organising, and maintaining the RDS.
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Assisting in meetings with external parties and representing the company in a professional manner.
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Assist in regulatory activities such as maintaining the Rexpharma IMP MIA with variations and annual maintenance.
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Assist the QP in the review of batch records, associated batch data and the issuance of certifications and logbooks/registries.
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Participate in inspection readiness and inspections as required.
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Managing the cloud server and office archival systems.
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Assist in office administrative activities such as maintaining social media, online tools, and other activities as determined by Quality Management.
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Maintain current training in accordance with the Rexpharma training curriculum.
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Excellent analytical, written and verbal communication skills.
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Disciplined, detail orientated, and strong time management skills.
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Self-directed and a strong ability to work independently.
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Excellent professional standards, and demonstrates good attention to detail.
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Knowledge in implementing/requirements of phase appropriate GMP with regard to manufacture and testing of IMP desirable.
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Excellent Quality Assurance and Quality Systems skills.
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Clinical Good Manufacturing Practice (GMP) knowledge.
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A strong self-starter with strong attention to detail.
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Clinical Good Manufacturing Practice (GMP) knowledge.
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Proficient in using computer software programs such as Microsoft Office.
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5+ years pharmaceutical or biotechnology industry experience (required).
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A bachelor’s degree in biology, chemistry, pharmacy, or a related field(required).
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Experience with clinical products or biologics a distinct advantage.
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Experience supporting the QP function and manufacturers importation authorisation an advantage.
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