- Perform as the QA representative for all stages of two automation projects, supporting qualification and validation activities as per project timelines in accordance with site procedures and GMP guidelines
- Provide QA advice and support to the project teams as required to ensure compliance with applicable regulatory requirements
- Participates in developing and approving SOPs to ensure quality objectives are met
- May conduct or serve as lead of investigations and CAPA recommendations related to manufactured products
- Develops solutions to more complex problems and identifies deviations from accepted practices and evaluates impact assessment as required
- Normally receives no instruction on routine work and general instructions on new assignments.
- Prior experiences in a pharmaceutical industry is preferred, guideline of 6+ years in relevant field with appropriate BS or BA qualification.
- Demonstrates proficiency in GMPs
- Demonstrates proficiency in the application of QA principles, concepts, industry practices and standards
- Demonstrates thorough knowledge of FDA and EMA standards and quality systems and interfaces with other site functions
- Demonstrates strong knowledge of six sigma and root cause analysis tools used for identifying and correcting deviation
- Demonstrates investigation skills, report writing skills, strong verbal, technical writing and interpersonal skills
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists