Almac Clinical Services designs and delivers bespoke packaging and logistical solutions for pharmaceutical companies conducting small or large clinical trials for the treatment of a range of diseases and illnesses. We ensure that a supply of clinical material is delivered across the globe to meet the needs of those patients enrolled in a trial, helping to improve patient lives daily.
Overall Role Objectives:
To perform Quality Assurance (QA) functions in reviewing GxP documentation in accordance with the principles of GxP and internal SOPs
Responsibilities:
General Duties:
- To check documentation for completeness and accuracy.
- To Identify any deviations from written procedures and inform Quality Control Supervisor.
- To attend meetings and assist with miscellaneous tasks when required.
- To perform duties under Quality Assurance personnel supervision.
- To perform ad hoc tasks or projects assigned.
Quality Assurance Administration:
- To maintain a secure and accurate document archiving system; control the movement of documentation
- including scanning, archiving and retrieving of GxP documents.
- To ensure documentation is handled, stored and easily retrieved in a controlled manner.
- To control the issue of documentation in accordance with internal SOPs.
- To manage Vault related tasks.
- To support and assist in customer audits.
Quality Assurance
- To assist in reviewing Lot to Country Release requests in accordance with internal SOP requirements.
- To collate and review building management system charts to ensure environmental data are within
- specifications.
- To facilitate batch document reviewing prior to release
- To liaise with the relevant departments to resolve any documentation queries or amendments identified
- To manage tasks / queries from CS Service Desk.
Criteria:
- Academic background in lifescience, or related studies, preferred
- Excellent verbal and written communication skills
- Able to demonstrate logical problem-solving
- Able to work consistently to a high standard under pressure
- Detail-oriented
Please note that applications for each internship vacancy shall be considered separately.
This is not a lab-based internship; the duration is 6 months. Our office is located in Changi Business Park.
