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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