Job Reference: JO-2007-65283_1594135362
As part of team of other QA specialists, the candidate may be responsible for performing a wide variety of activities to ensure compliance with applicable regulatory requirements for:
- Leading customer complaint investigation coordination
- Leading of investigations and corrective and preventive actions (CAPA)
- Compiling data for annual product quality reviews and generates and reports on site quality system metrics
- Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
- Works directly with cross-functional departments to ensure that quality system requirements are met
- Participates in the development of training programs regarding all aspects of producing quality products
- Participates in the completion of internal audits and walkthroughs
- Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs)
- May act as a lead QA support and signoff for projects and related validation activities
- May provide support for onsite departments in assessing and approving changes and deviations related with IT and electronic systems
- 4+ years of relevant experience in a GMP environment related field and a BS.
- 2 + years of relevant experience and a MS.
- 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.
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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