Roles and Responsibilities:



To own, manage, develop, and improve the CAPA and RCA process and metrics



Redesign and simplify the current CAPA process.



Thru performance management ensure CAPAs are closed on time and closure is effective.



Review data from CAPA system to perform deep dives and problem solving to ensure system is working correctly and any risks are escalated



Train, coach, and mentor personnel on correct RCA and CAPA Issuance.



To own, manage, develop, improve, and simplify the site Change Control system.



Ensure all site changes are promptly raised, potential impact is evaluated prior to execution .



Ensure there is a process in place where correct SMEs perform the impact assessments of any change .



Implement frequent governance with all site representatives to ensure change controls are correctly advanced.



Train, coach, and mentors site personnel at all levels on QMS standards, process.



To own, manage, develop, improve, the self-inspection and management monitoring process.



Review data from audit systems to perform deep dives and problem solving to repeat and or critical findings are properly managed.



Ensure self-inspection process is effective to challenge current procedures.



Ensure management monitoring is effective on implementing cGMps and company QMS expectations into the process and shop floor.



Work with deviation, supplier program to support correct RCAs are performed on a timely matter.



Supports TTS program improvement to ensure agile implementation agreements along the supply chain.   



Proven expertise in the management/use of quality systems.



Good understanding of regulatory requirements within all Markets supplied by site; able to interpret and provide consultation to ensure compliance.



Strong analytical, numerical, and reasoning skills.



Excellent technical writing skills, verbal communication skills, and presentation skills.



Experience in auditing; negotiation and facilitation of corrective actions.



Project management skills.



Ability to analyse data, effectively summarize findings and draw conclusions, excellent problem-solving skills.



Good understanding of statistical techniques.



Computer skills.



Detailed orientated.