Quality Engineer (Validation)

Job description

JOB DESCRIPTION:

Primary 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.

     

The base pay for this position is
N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ANSC Nutrition Supply Chain

        

LOCATION:

Singapore > Singapore : SN01

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable