* Performs a wide variety of activities in the role of QA specialist to ensure compliance with applicable regulatory requirements through support of the site Serialisation system upgrade.
* Maintains programs and processes to ensure compliance with current Good Manufacturing Practices (GMPs).
* Quality review and contribution to change management procedure(s) of the project.
* Quality review and contribution to lifecycle validation documentation: IQ, OQ, PQ in conjunction with other project team members (SME, System Owner, Business Owner and Validation).
* Quality review and contribution to risk assessments (Process and Electronic).
* Precipitate and contribute to project design reviews, team meetings and process development.
* Performs activities to ensure compliance with applicable regulatory requirements.
* Participates in developing Standard Operating Procedures to ensure quality objectives are met.
* Maintains processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
* Develops solutions to more complex problems, identifies variance from accepted practice, and evaluates impact as necessary.
* This is an advanced position requiring significant expertise/specialization in area of work.
* Works on complex issues where analysis requires an in-depth assessment, considering many variables, and potential consequences.
* 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.
* 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.
* May facilitate external audits/inspection processes, supporting implementation of corrective actions as agreed.
* May assist with compliance audits as required.
* 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.
* Demonstrates proficiency in Good Manufacturing Practices (GMPs).
* Demonstrates proficiency in application of QA principles, concepts, industry practices and standards with specific emphasis on validation and engineering requirements.
* 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.
* Ability to deliver in a challenging environment
* System and IT knowledge.
* Serialisation Knowledge
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