Quality Engineer (Validation)
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Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
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/AIn 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)
Required Experience:
IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
