Quality Assurance/ QA Associate
About us
Xerimis is a privately held, specialized company providing customized clinical packaging services on a global basis. Serving pharmaceutical, biotechnology and clinical research organizations of all sizes and for each phase of clinical development, Xerimis holds true to the traditional approach of building long-term relationships with clients. Whether clients are currently working on an initial Phase I trial or are in the midst of pivotal Phase III studies, we recognize that each trial is critical and we provide outstanding service and responsiveness to clients so that timelines are met or exceeded.
The role
The QA Associate is responsible for performing the daily QA activities that support the Quality Assurance department and facilitate the overall EU GMP/GDP compliance of Xerimis Ltd. A key part of this role is supporting the Qualified Person's (QP's), providing them with the relevant information they need.
Key Roles and Responsibilities
If you are still reading and still interested, then we would love to hear from you! Please apply directly via the link!
In some circumstances we may be unable to contact every applicant with feedback. If you do not get a response from us within 2 weeks of the advert closing date, then please assume you have been unsuccessful on this occasion.
HR Revolution recruitment team.
Application notice... We take your privacy seriously. When you apply, we shall process your details and pass your application to our client for review for this vacancy only. As you might expect we may contact you by email, text or telephone. Your data is processed on the basis of our legitimate interests in fulfilling the recruitment process. Please refer to our Data Privacy Policy & Notice on our website for further details
Xerimis is a privately held, specialized company providing customized clinical packaging services on a global basis. Serving pharmaceutical, biotechnology and clinical research organizations of all sizes and for each phase of clinical development, Xerimis holds true to the traditional approach of building long-term relationships with clients. Whether clients are currently working on an initial Phase I trial or are in the midst of pivotal Phase III studies, we recognize that each trial is critical and we provide outstanding service and responsiveness to clients so that timelines are met or exceeded.
The role
The QA Associate is responsible for performing the daily QA activities that support the Quality Assurance department and facilitate the overall EU GMP/GDP compliance of Xerimis Ltd. A key part of this role is supporting the Qualified Person's (QP's), providing them with the relevant information they need.
Key Roles and Responsibilities
- Assist the Qualified Person in the preparation of QP Declarations and QP Certificates - involving the creation of supply chain diagrams, product specification files, review of regulatory submission documents and review of manufacturing batch records
- Assist with the generation, revision and review of Standard Operating Procedures, Data Capture Forms and other GMP/GDP documents
- Maintain EU GMP/GDP documentation storage of all pertinent documents, including scanning, filing and archiving (manually & electronically)
- Provide QA support to all GMP/GDP activities including receiving, storing, distributing, returns processing and disposition of products
- Complete incoming quality control inspection of all materials
- Participates in regular meetings with clients
- Data entry and verification in the Inventory Control System (ICS)
- Provides QA release of products and assists with the proper storage of quarantined and rejected materials
- Assists with the development and implementation of the Corrective Actions & Prevention Actions (CAPA) programme; maintains and updates the CAPA tracking system
- Related bachelor's degree or equivalent
- Strong understanding of GMP and GDP in the pharmaceutical industry
- Understanding/ Familiarity of GCP in the clinical trials industry
- Experienced working within the clinical supplies industry
- Skilled at prioritising requirements
- Effective time management skills
- Excellent interpersonal skills
- Good communication skills - written and verbal
- Excellent mathematical skills
- Computer literacy skills
- Attention to detail
- Strong problem solving skills
- In-house training programmes
- On the job training with an experienced individual
- External seminars/conferences
- Literature
- Gowning in secondary packaging areas
- Some physical lifting as required
If you are still reading and still interested, then we would love to hear from you! Please apply directly via the link!
In some circumstances we may be unable to contact every applicant with feedback. If you do not get a response from us within 2 weeks of the advert closing date, then please assume you have been unsuccessful on this occasion.
HR Revolution recruitment team.
Application notice... We take your privacy seriously. When you apply, we shall process your details and pass your application to our client for review for this vacancy only. As you might expect we may contact you by email, text or telephone. Your data is processed on the basis of our legitimate interests in fulfilling the recruitment process. Please refer to our Data Privacy Policy & Notice on our website for further details