Quality Assurance Specialist
il y a 4 semaines
Quality Assurance Specialist
ProductLife Group is seeking a Quality Assurance Specialist to support the development, implementation, and maintenance of the corporate quality system.
About us
Group 10 Responsibilities
- Collaborate with the 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 requirements 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 Profile
We are looking for someone with the following qualities:
Bachelor's degree or Higher degree in Science-related field, or equivalent experience. QA and PV Education
Quality Specialist/Expert with background in both Quality & Pharmacovigilance and experienced in GVP Regulation. Can support facilitation and management of GVP client audits.
Excellent presentation skills and experienced facilitator.
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