DirecciónPrimary Function/ Primary Goals/ Objectives:
- Ensure that change control and validation activities are executed in a timely manner.
Major 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 events
- Support resolution of validation events and escalate concerns in a timely manner.
- Support in equipment and process walkdowns
- Weekly, Monthly and Quarterly reporting as required for own business area
- Support 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 functions
- Develop and execute business area improvement projects
- Participate in internal and external audits
- Participate in division and site projects, improvement activities and technical sharing platforms
- Any other ad-hoc requests as assigned by the supervisor.
Skills/Experience Requirements:
- Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) in a food or pharmaceutical manufacturing industry.
- Familiarity in developing SOPs and work flows
- Knowledge 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 English
- Ability 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.
Education:
- Degree in a Science or Engineering discipline.
- Diploma in a Science or Engineering discipline with minimum 3 years working experience.
