* 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.
* Prior experience in pharmaceutical industry is preferred
* Previous experience with Change Management, Validation and Commissioning Documentation requirements is highly desirable.
* 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.
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