Description
This position requires a strong understanding of current and pending EU GMP requirements, ensuring compliance with regulatory standards. The role demands excellent interpersonal skills to facilitate collaboration with other departments, ensuring compliance and fostering productive working relationships. The candidate must be self-motivated, flexible, well-organized, and a strong team player, with the ability to prioritize work based on departmental and site requirements. Excellent verbal and written communication skills are essential.
Key Responsibilities:
1. Provide technical support for new and ongoing projects in compliance-based decision-making.
2. Review and provide technical approval of company risk assessments in accordance with QRM policies and procedures.
3. Lead and review process investigations, ensuring proper documentation and implementation of corrective actions where necessary.
4. Conduct routine quality audits of the facility to ensure compliance and proactively resolve arising issues.
5. Conduct external audits, compile audit reports, and lead the collation of responses where applicable.
6. Prepare and deliver annual GMP training programs for the site.
7. Ensure quality records such as Deviations, SCARs, Rejection Notices, and CAPAs are reviewed, approved, and closed in a timely manner in QPULSE QMS.
8. Assist in managing the site CAPA system, change control system, and customer complaint system.
9. Support the Site Quality Council (SQC) meetings.
10. Conduct quality review and approval of MWOs, PWOs, and BPWOs for the Chanelle Group.
11. Update existing quality procedures in line with validation findings and collaborate with relevant departments.
12. Drive continuous improvement initiatives to enhance the Quality/GMP system.
13. Maintain records for company KPIs as per Quality Management Review requirements.
14. Provide timely feedback on customer and production queries.
15. Prepare product quality review reports for the Chanelle Group.
16. Prepare and review investigation reports and risk assessments.
17. Develop and review Standard Operating Procedures, Cleaning Instructions, Preventive Maintenance procedures, and Process Operating Instructions.
18. Assist in troubleshooting product issues.
19. Perform any other duties assigned by the Compliance Department Manager.
Education & Experience:
1. Bachelor's degree in a Science-related discipline.
2. Minimum of 4 years of experience in a similar Quality Assurance role in the Pharmaceutical Industry (preferred).
3. Strong knowledge of EU quality-related pharmaceutical regulations.
Skills & Competencies:
1. Strong organizational skills, personal efficiency, and time management abilities.
2. Ability to build and maintain professional relationships and collaborate across departments.
3. Strategic decision-making skills and the ability to influence business operations.
4. Knowledge of best practices in process management, change implementation, coaching, and mentoring.
5. Strong ability to prioritize key initiatives, drive growth, and set KPIs to monitor performance.
6. Positive and proactive attitude, energized by responsibility.
7. Practical, action-oriented approach to managing priorities and teams.
8. Proficiency in MS Office and other relevant software tools.
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