Job Description

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 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.

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 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.

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:

No

MEDICAL SURVEILLANCE:

Yes

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)