Specific activities and responsibilities:

- 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 robust 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.

Required education: Bachelor s or higher graduate degree in a science related field, or equivalent experience

Required experience

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

Additional experience and/or skills

Client relationship

Autonomy proactivty

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

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