(Senior) Assistant Manager
3 days ago
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(Senior) Assistant Manager - Compounding Hub (Quality Assurance), 2-years contract
Job ID: 7818
Job Function: Administration
Institution: National University Hospital
Career in the Hospital
Join our incredible team at the National University Hospital (NUH), where we believe that a hospital is more than just a workplace. Every day, we witness the remarkable impact that our healthcare professionals can have on individuals, families, and entire communities.
At NUH, we are driven by a shared purpose – to lend a helping hand to those in need, to be a source of support and healing, and to empower patients to live their best lives.
We are looking for passionate and committed individuals to join us as we transform lives and create a lasting impact in the lives of our patients. The impact you make at NUH will be profound, regardless of the role you take up in the hospital.
About NUH
The National University Hospital (NUH) is Singapore’s leading university hospital, with a proud heritage dating back to 1905 with the establishment of what’s now the NUS Yong Loo Lin School of Medicine. Our strong ties with the medical school have shaped us into a unique institution, allowing us to seamlessly integrate clinical care with teaching and research. As a university hospital, we go beyond the realm of providing tertiary medical care. We are a hub of knowledge and innovation, attracting healthcare professionals who are passionate about pushing boundaries and making significant contributions to the field.
About Department and Purpose of the Position
The incumbent will support the project planning and work on Quality Assurance (QA) involving the implementation of validation processes, identifying deviations and potential risks in the manufacturing processes and recommends corrective and preventive actions to eliminate/ minimise such risks.
He/She will support the coordination of workshops, liaising with clinical team to formulate procurement specifications and supporting the infra designing for CIFO-FD to finalize the RFP specifications for facility construction. He/She will also be responsible for implementing and verification of quality standards in NUHS-NHG Compounding Hub during stable state as the QA role and supports the product release.
In addition, he/she may be involved in conducting audits, handles quality queries, delivers quality-related training, and is responsible for ensuring that documents are organised and managed according to standard procedures and requirements.
Key Responsibilities
Responsibilities and Duties
Design and Planning of Facility
Supports various activities outlined to meet the milestones on the strategic planning roadmap.
Coordinate stakeholders / subject matter experts for workshops.
Supports procurement activities.
Operational Management and Service Delivery
Establish, monitor, and review QA Standard Operating Procedures.
Collaborate with pharmacy production colleagues to ensure productions are complaint to GMP or relevant National guidelines.
Contribute to the development, monitoring, review and updating of product specifications for extemporaneous medicines prepared in the pharmacy lab.
Review and provide quality assurance approval/sign off for pharmacy production extemporaneous product specifications including assessment and evaluation of starting materials, finished products, packaging materials, labels and processing instructions (e.g. manual worksheets).
Product Safety
To investigate and report on medicine defects, arising from both commercial and NUH-made products.
To lead and co-ordinate actions within NUH in response to drug recall and field safety notifications issued by HSA.
To provide QA support and advice to the Pharmacy Procurement team for the purchase of medicines.
Pharmacy Department Quality Assurance
Provide advice and support for temperature monitoring systems for the storage of medicinal products.
Collaborate with pharmacy team for validation of facilities, equipment or processes in order to ensure the project deliverables remain compliant with regulatory requirements.
Assist with preparation and present written and verbal reports for any critical deviations.
May be assigned as Releasing Officer and to ensure extemporaneous products are released in timely manner.
Supports the recall of any defective products manufactured within NUH.
Others
To participate in specific projects as and when required.
To undertake other duties as requested by the section in charge.
Key Requirements
Bachelor’s degree in science, Pharmacy, Pharmaceutical Science, or equivalent
More than >5 years of relevant work experience in new facility setup
Experience in quality control or assurance (preferrable in Pharmaceutical/biotechnology/medical device/healthcare industry)
Extensive knowledge of quality control, quality management system and validations requirement, with third party customer/supplier or vendor management experience.
Extensive knowledge in regulations and industrial guidance, and experience with technological
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