Quality Systems and Compliance Manager

Quality Systems and Compliance Manager

Reporting to the Technical Director, the Quality Systems and Compliance Manager is responsible for management of Documentation Compliance Manager (DCM) and archiving in relation to QMS systems.

Responsibilities include managing and coordinating the Internal audit system in GWWO, managing Change Control system, CAPA system, Supplier qualification process and supplier complaints, Quality SAP process and other activities related to QMS.

Other additional duties may be assigned by the Technical Director from time to time if required.

Contribution to the continuous improvement of the Quality Management System is required.

Certification in auditing will be considered an advantage.

Experience in working in aseptic area and understanding of Annex 1 requirements will be considered an advantage.

RESPONSIBILITIES

• Management of Documentation Compliance Manager (DCM) system
• Provide Reports to site in relation to Quality Management System (QMS) as required.
• Provide regular reports on site's metrics to Technical Director
• Management of Documentation Archive for QMS documentation.
• Authoring of Standard Operating Procedures (SOP's) in relation to the Documentation System
• Management and ownership of the Change Control system in GWWO
• Management of deviations related to Documentation control
• Management of Annual Product Reports
• Management of GMP introductory and annual refresher training for all GWWO employees
• Management of Quality SAP activities
• Communicate with cross functional departments sites' compliance issues and organise retraining where require
• Communication with the manufacturing sites of Grifols in relation to QMS activities where appropriate
• Management of Supplier complaints
• Conducting audits of suppliers/outsourced providers
• Management and coordination of Internal audit system in GWWO
• Provide support ensuring external audit readiness and during external audits and corporate internal audits
• Ensures the corrections of findings, risks and recommendations are promptly and thoroughly incorporated into the quality systems
• Identifies and shares "Best Practices"
• Communicate site compliance issues and organise site retraining where require
• Participate in investigations of quality system issues and drives CAPA implementation to ensure CAPA findings, risks, recommendations, and outcomes are appropriate and are clearly documented and communicated
• Trends, analyses, and reports on quality data to improve product and process Quality; develop recommendations based on data analyses

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

REQUIREMENTS

• Excellent communication skills
• Competence in Microsoft packages specifically word, excel and PowerPoint
• Ability to work proactively on own initiative
• Excellent technical writing and analytical skills
• Flexibility
• Results orientated
• Process improvement and procedure writing expertise
• Experience of conducting audits
• Demonstrated project management experience in leading cross-functional teams
• Detail oriented, well organized and able to work independently and in teams.
• Good communication skills both verbal and written
• Flexible, able to adapt quickly to change in a fast-paced environment
• Solid problem-solving skills
• Willing to travel as required (auditing of outsourced activities)
• Previous experience in auditing
• Previous experience in facilitating of health authorities audits
• Minimum of 5 years' experience in Quality Systems/Quality Assurance environment
• BSc or MSc in a science, pharmacy or related discipline.
• Excellent understanding of GMP regulations and guidelines
• Previous experience in managing/supervising
• Experience of conducting audits
• Recognized certification in auditing an advantage