- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements through support of Packaging and Engineering functions.
- Works directly with Packaging and Engineering functions to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- Reviews routine Packaging and Engineering documents including tech trial protocols and reports
- Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
- May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to packaged products.
- Reviews and evaluates proposed changes, qualification and validation documentation as related to engineering and manufacturing.
- May facilitate external audits/inspection processes, supporting implementation of corrective actions as agreed.
- May assist with compliance audits as required.
- Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
- Participates in developing Standard Operating Procedures and writes and/or implements changes to controlled documents to ensure quality objectives are met.
- Normally receives no instruction on routine work, general instructions on new assignments.
- 6+ years of relevant experience in a GMP environment related field and a BS or BA.
- 4+ years of relevant experience and a MS.
- Demonstrates proficiency in Good Manufacturing Practices (GMPs).
- Previous experience with Change Management, Validation and Commissioning
- Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like packaging and engineering.
- Demonstrates strong knowledge of Six Sigma, Lean and root cause analysis tools used for identifying and correcting deviations.
- Demonstrates audit and investigation skills, and report writing skills.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists