Quality & Process Improvement (QPI) Expert 751

ProductLife Group is looking for a Quality & Process Improvement (QPI) Expert to join us in Prague.

About us

Group 10

Collaboration with Head of Quality and Process Improvement to support ongoing development, implementation and maintenance of the corporate quality system.

Develop and maintain the ProductLife Group quality management system, including requirement for obtaining ISO 9001 certification, with ongoing alignment with the corporate quality management system

Recommend, develop and maintain the controlled document system, including SOPs, WPDs and any associated forms and templates.

Ensure data in Quality trackers / system are accurate, up to date and entered in a timely manner, to enable automated reporting.

Identify process efficiency/effectiveness issues and provide solutions for improvement.

Maintain a strong working knowledge of SOPs as well as ICH, GCP, local regulations and guidelines.

Provide quality verification and oversight including corrective action plans for activities not meeting quality standards.

Provide interpretation and relay to the Managers the need for continuous improvement of processes.

Management and implementation of ProductLife Group annual risk based audit program (occasional travel)

Management of internal and client audit and inspection findings.

Act as the key point of contact for client auditors and vendors PLG audits.

Support and maintain quality activities for oversight of vendors, suppliers and subcontractors to ensure they are functioning appropriately and audit as required.

Oversee, maintain and improve training programs within ProductLife Group.

Work with the departments to develop guidelines and metrics to assure quality and compliant deliverables.

Quality representative at Global Quality Management Team meetings (occasional travel).

Collaborate effectively with other managers.

Group 13

Bachelor’s or higher graduate degree in a science related field, or equivalent experience

8 + years’ experience within a Quality role in Pharmaceutical industry + previous role or knowledge in PV domain

knowledge of methodologies such as Six Sigma, Lean or CMM+ ISO 9001 2015 standard

Quality assurance specific training

Process modeling / reengineering methods and tools (Visio)

Skill in MS Office tools, Excel,

SharePoint, Content Management tools

Knowledge in Computer System validation, GAMP4, 21CRF Part 11

Quality & Process Improvement (QPI) Expert 751