This is a contract role and this position requires experience and expertise in the support of multiple Packaging and Packaging Engineering projects including review and sign off of associated validation documentation from a quality perspective. The successful candidate will be required to work on complex issues where analysis requires an in-depth assessment, considering many variables and potential consequences. The candidate will be required to exercise judgment to determine appropriate action with minimal supervision. The candidate will need to have demonstrated proficiency in application of QA principles, concepts, industry practices and standards with specific emphasis on packaging, engineering and validation requirements.
* Performs a wide variety of activities to ensure compliance with applicable regulatory requirements through support of Packaging and Engineering functions.
* 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.
* Reviews routine Packaging and Engineering documents including tech trial protocols and reports.
* 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.
* May facilitate external audits/inspection processes, supporting implementation of corrective actions as agreed.
* May assist with compliance audits as required.
* Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
* 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.
Knowledge and Skills:
* 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.
* Demonstrates audit and investigation skills, and report writing skills.
* Demonstrates strong verbal, technical writing and interpersonal skills.
* Demonstrates proficiency in Microsoft Office applications.
* Knowledge and experience of Packaging Operations a significant advantage.
Typical Education and Experience:
* 6+ years of relevant experience in a GMP environment related field and a BS or BA.
* 4+ years of relevant experience and a MS.
* Prior experience in pharmaceutical industry is preferred.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.