* Participates within inter-departmental and cross-functional teams
* Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements
* Reviews routine data for release of starting materials / packaging components
* Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions
* Identifies problems and generates alternatives and recommendations
* Serve as a lead of investigations and corrective and preventive action (CAPA) plans
* Completion of routine to more complex/non-routine projects/assignments
* Normally receives very little instruction on routine work, general instructions on new assignments
* Writes and/or implements changes to controlled documents
* 6+ years of relevant experience in a GMP environment related field and a BS.
* Prior experience in pharmaceutical industry is preferred
* Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
* Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
* Demonstrates strong verbal, technical writing, presentation 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