QC Specialist
4 weeks ago
QC Specialist – Method Transfer
Main Responsibilities
- Planning and execution of a method transfer
- Responsible for analytical investigations and problem-solving activities
- Writing of analytical documents linked to the method transfer
- Responsible for validation/qualification of analytical equipment
- Training of personnel for execution and review, review of data, and completion of documentation
- Complete review/approval of validation documentation for other team members on request
Compliance
- System documentation, including SOPs, protocols, validation lifecycle/CSV documentation
- Ownership of quality systems actions (IRs, CAPA, CC) ensuring timely closure and performance trending
- Participation in internal and external audits and active follow-up on audit items
- Identifying productivity and compliance opportunities and driving same to completion
Qualifications and Experience
- Minimum 2 years experience in the pharmaceutical/medical device industry
- Degree (or equivalent) in Chemistry/Microbiology, or in a Science/Engineering subject
- Experience in method transfers
- Experience in validation/qualification of analytical equipment
- Familiar with QC systems and processes, especially LIMS, MODA & Veeva
- Experienced in data compilation, review and report generation
- Experienced in data integrity requirements for QC
- Project management - leading & oversight as well as contributory role
Skills Required:
- Highly attentive to detail
- Self-motivated, goal-driven person
- Experienced in technical problem-solving
- Good organisational skills
- Strong ability to perform, challenge and positively influence in an interactive team environment
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