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:
* Participates in the writing of annual product reviews and gathering relevant data from the quality system and related departments.
* Complies and presents reports on site quality system metrics.
* Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
* Coordinating or leading investigations and corrective and preventive actions (CAPA).
* Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met
* Provides support for onsite departments in assessing and approving quality system records such as deviations, change controls and document updates.
* Supports complaints investigations with visual assessment of returned complaint samples to determine any counterfeit material.
* Participates in the development of training programs regarding all aspects of producing quality products.
* 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.
* 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.
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