Social network you want to login/join with:
QC Specialist - Method Transfer, Cork City
Client:
Location:
Cork City, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
8fa1c50ffb08
Job Views:
130
Posted:
03.03.2025
Expiry Date:
17.04.2025
Job Description:
QC specialist – Method Transfer
Main Responsibilities
1. Planning and execution of a method transfer
2. Responsible for analytical investigations and problem-solving activities
3. Writing of analytical documents linked to the method transfer
4. Responsible for validation/qualification of analytical equipment
5. Training of personnel for execution and review, review of data, and completion of documentation
6. Complete review/approval of validation documentation for other team members on request
Compliance
1. System documentation, including SOPs, protocols, Validation lifecycle/CSV documentation
2. Ownership of quality systems actions (IRs, CAPA, CC) ensuring timely closure and performance trending
3. Participation in internal and external audits and active follow-up on audit items
4. Identifying productivity and compliance opportunities and driving same to completion
Qualifications and Experience
1. Minimum 2 years experience in the pharmaceutical/medical device industry
2. Degree (or equivalent) in Chemistry/Microbiology, or in a Science/Engineering subject
3. Experience in method transfers
4. Experience in validation/qualification of analytical equipment
5. Familiar with QC systems and processes, especially LIMS, MODA & Veeva
6. Experienced in data compilation, review, and report generation
7. Experienced in Data Integrity requirements for QC
8. Project Management - leading & oversight as well as contributory role
Skills Required:
1. Highly attentive to detail
2. Self-motivated, goal-driven person
3. Experienced in technical problem solving
4. Good organisational skills
5. Strong ability to perform, challenge, and positively influence in an interactive team environment
#J-18808-Ljbffr