MAIN PURPOSE OF ROLE  

Ensure that change control and validation activities are executed in a timely manner.

MAIN RESPONSIBILITIES  

Comply to all policies and standards.Develop, execute and review validation protocols and related documentation in accordance with Abbott procedures and policies.Lead Failure Mode Effects Analysis (FMEA) for new equipment installations or changes.Manages site Validation Review processes (VRB), review and approve site change controls (plant and laboratories related) and validation change requests.Perform root cause analysis and identify corrective and preventive actions in addressing quality eventsSupport resolution of validation events and escalate concerns in a timely manner.Support in equipment and process walkdownsWeekly, Monthly and Quarterly reporting as required for own business areaSupport Monthly and Quarterly Quality Management Review (QMR) and Business Management Review (BMR)Coordinate and support periodic plant stoppage activities related to validation and change control functionsDevelop and execute business area improvement projectsParticipate in internal and external auditsParticipate in division and site projects, improvement activities and technical sharing platformsAny other ad-hoc requests as assigned by the supervisor.

 

QUALIFICATIONS  

 

Education  

Degree in a Science or Engineering discipline.Diploma in a Science or Engineering discipline with minimum 3 years working experience.

 

Experience/Background  

Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) in a food or pharmaceutical manufacturing industry.Familiarity in developing SOPs and work flowsKnowledge of problem-solving tools (e.g. 6M Analysis, Fishbone, 5 Whys, etc.).Familiarity with international and technical standards is a plus (ISO, FSSC etc)Proficient in Microsoft applications (Powerpoint, Word, Excel)Team player with initiative, drive, good communication skills and a strong command of written EnglishAbility to do data analysis using Minitab, JMP is a plus.Experience in manufacturing process design and equipment design or application is a plus.Proven problem-solving capability, customer focus and commitment to continuous improvement.