- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements
- Coordinates and writes annual product reviews
- Supports changes in processes and systems through change control review and review of related validation documentation
- Participates in developing SOPs to ensure quality objectives are met
- Ability to recognize deviations from accepted practice is required
- Conducts or serve as lead of investigations and CAPA recommendations related to manufactured products and systems used
- Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMP)
- May participates in the tracking and completion of product complaint investigations
- Participates within inter-departmental and cross-functional teams
- Normally receives very little instruction on routine work and general instructions on new assignments.
- Prior experience in pharmaceutical industry is preferred
- Demonstrates working knowledge of quality assurance systems, methods and procedures
- Demonstrates investigation skills, report writing skills, strong verbal, technical writing and interpersonal skills
- Demonstrates basic knowledge of Lean practices and root cause analysis
- Demonstrates working knowledge of current Good Manufacturing Practices (GMPs)
- Demonstrates proficiency in Microsoft Office applications.
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
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The Life Science Specialists