Job Description

JOB DESCRIPTION:

Primary Function/Primary Goals/Objectives

• Develops and implements company and regulatory quality standards in the manufacturing facility.
• Responsible and SME (Subject Matter Expert} for site CAPA and Validation process and ensure compliance to site, Division and regulatory procedures and policies.
• 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
• Develops, implements, revises and maintains quality standards, tools and methods for processing materials into finished products .
• Drive and own all related Quality metric related to CAPA, Validation .
• Provide training related to CAPA, Validation process.
• Drives quality improvement and cost reduction using Six Sigma or Lean methodology.

Responsibilities

• Undertake plant events related investigations {pNC and NC}
• Perform root cause analysis and identify corrective and preventive actions in addressing quality events.
• Drive and ensure event are closely timely to meet MSP, escalate when there is challenges.
• Monitor site CAPA and perform track and trending of monthly and quarterly events cause codes
• 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.
• Support resolution of validation events and escalate concerns in a timely manner.
• Support in equipment and process walkdowns.
• Perform Weekly (Tier 4}, Monthly and Quarterly Quality Management Review {QMR} and Monthly Business Review (MBR) and any Division quality metric to drive impro vement .
• Develop SIC {Short Interval Control} to ensure all quality metric are met and escalate timely for action.
• Support site new product introduction activities (Deviations, FLTS documentation, flushing studies} and non-commercial product production control.
• Review and approve event related rework protocol s.
• Coordinates and support periodic plant stoppage activities and ensure product line/area release in a timely manner for commercial production .
• Develop and execute business area improvement projects.
• Participate in internal and external au dit s.
• Act as site SME for CAPA and Validation and ensure compliance to site, Division and regulatory procedures and policies.
• Provide training to site personnel in CAPA and Validation Process.
• Participate in division and site projects, improvement activities and technical sharing platforms
• Any other ad-hoc requests as assigned by the supervisor.
• Good knowledge of procedures and activities within own work area .
• Applies research, information gathering and analytical skills.
• Works under general direction, seeks assistance as needed.
• Works with team to support achievement of project milestones and deliver on internal and/ or external commitments.
• Contributes through quality and accuracy of own work.
• Conveys information in a concise and professional manner.
• Any other duties as assigned by supervisor.

Requirements

• 0 to 3 years of relevant experience or equivalent combination of education and work experience. Good practical knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) in a food or pharmaceutical manufacturing industry.
• Knowledge of problem-solving tools (e.g. 6M Analysis , Fishbone, 5 Whys, et c.). Ability to do data analysis using Minitab, JMP is a plus.
• Team player with initiative, drive, good communication skills and a strong command of written English.
• Proven problem -solvin g capability, customer focus and commitment to continuous improvement.
• Good report writing skills.

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: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Not Applicable

Abbott