MSD Senior Quality Officer 

France, Noumea 

681349936

Job Description

POSITION OVERVIEW: BASIC FUNCTIONS & RESPONSIBILITIES:

• Be responsible for product quality related matters, escalate any local product quality related issue to Site Quality manager, Regional Quality manager.
• Implement, monitor and continuous improvement the Quality Management System
• Minimize risk by a routine self-inspection, corrective and preventative action (CAPA)

Quality Management System:

• Ensure the site compliance with Good Manufacturing Practices (GMP) and Good Storage Practices (GSP)
• Ensure Management Notification (MN) within the required time frame.
• Maintain and improve the Quality Management System
• Maintain the local procedure, conduct the gap assessment for new cooperate procedure or new regulation of local or internation requirement and propose the appropriate actions to close the gap.
• Be responsible for initiating and reviewing the new product specification, ensure it complies with internal and local regulations.
• Quality metric data collection, data analysis and propose appropriate actions

Batch Release:

• Ensure products comply with internal specification, local requirement, and marketing authorization by approving/rejecting batches.

Quality Events:

• Complaint handling: Ensure the process is in place to manage the product complaints; data collection, coordinate with relevant department for investigation, define Root cause and appropriate CAPAs within the required timeline, trending as per internal requirement and record retention.
• Create, execute, and close change controls that may affect the quality attributes of the product. Assist the change control system management.
• Create and resolve deviations; ensure deviation completion is within requirements and CAPAs are completed by target date.

Quality Plan:

• Develop and execute the Quality plans as per internal requirements and local regulations as applicable.
• Adhere to and meet the Quality plan actions target due date.

Auditing and Inspection:

• Lead self-inspector: Scheduling, kick-off, implementing, self-inspection report summary.
• Conduct self-assessment of quality systems at least annually to maintain a state of inspection readiness for the manufacturing site.

• Learning & Development:

  Act as L&D coordinate of site.

DesiredExperience/Education/Skills:

• Graduated from University with majors in Pharmacy / Veterinary Medicine / Aquaculture / Chemical Technology / Biochemistry / Biotechnology.
• Knowledge of: WHO GMP – GSP – GLP, HACCP
• At least 5 years of experience working in the QA department forpharmaceutical/veterinarymanufacturing plants,
• Proficient in English.
• Proficient in using software such as Word, Excel, PowerPoint or Power BI is a plus.
• Experience in using SAP, LIMS
• Project management and team management experience

Additional information:

• Good time and task management skills
• Diligent, honest, and responsible for work
• Capable of working both independently and in a team
• Logical and critical thinking skills
• Problem analysis and solving skills
• Flexible and adaptable to work in a changing environment
• Ability to work under pressure and meet deadlines

Current Contingent Workers apply

Not Applicable

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