Quality Assurance/ QA Manager
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 Manager is responsible for managing the Quality Assurance Department and ensuring the overall EU GMP/GDP compliance. We are seeking a motivated individual who is interested in the management of people and can help others to understand how their role fits into the greater operations of the business.
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 Manager is responsible for managing the Quality Assurance Department and ensuring the overall EU GMP/GDP compliance. We are seeking a motivated individual who is interested in the management of people and can help others to understand how their role fits into the greater operations of the business.
Key Roles and Responsibilities
- Day to day management of the QA team
- Providing QA support to all GMP/GDP activities - including receiving, storing, distributing, returns processing and disposition of products
- Providing QA release for products
- Named as the primary Responsible Person (WDA(H) License)
- Named as the Quality Controller (MIA IMP and MS Licenses)
- Generation, revision and review of the Standard Operating Procedures (SOP), Quality Master Plan, Site Master File, policy documents and other GMP/GDP documents
- Training of staff in line with SOP
- Ensuring that GMP/GDP documentation is properly controlled and that appropriate systems exist for scanning, filing and archiving
- Oversee investigation and resolution of operational discrepancies and client complaints
- Oversee and initiate the Corrective Action and Preventative Action (CAPA) programme
- Perform quality improvement assessment and changes
- Delegate tasks to the team as necessary
- Related bachelor's degree or equivalent
- Experience in examining and re-engineering operations and procedures, formulating policy and developing and implementing new strategies and procedures
- 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
- Comfortable in a client facing capacity
- Strong management experience
- Good at prioritising requirements
- 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