Abbott Snr Quality Systems Specialist - Regional QA in Singapore, Singapore

THE POSITION:

Regional Management Review, Metrics and Training Coordinator is responsible for implementing and maintaining the APAC EPD Training, metrics and management review programs, as well as related activities to ensure management awareness of the health of the quality system.

CORE JOB RESPONSIBILITIES:

  • Leads Regional Management Reviews with APAC EPD leaders.

  • Experience of using statistical tools to track and trend the Quality metrics.

  • Creates and maintains data, documentation and systems to track, monitor, and support the divisional metrics and management review program. Monitor regional quality metrics and performance by gathering relevant data and producing statistical reports to support decision process of continual improvement activities.

  • Analyze Quality performance metrics for site and above site level and as regional coordinator and act as bridge between division and sites.

  • Ensure CAPA (Corrective Actions/ Preventive Actions) for the action items indicated through are addressed and successfully implemented.

  • Interacts with regional functions and represents APAC EPD on divisional initiatives related to Training, Metrics and Management Reviews. Participates in developing/improving compliance against the metrics for APAC EPD

  • Publishes EPD regional metrics to division QA, as requested

  • Establishes regional requirements for the EPD Training Quality System. Creates training materials and delivers training, as requested.

  • Liaison to sites and other regions for training, metrics, and management review topics.

  • Leads process improvements, strategic programs, risk assessments and other projects related to training, metrics, and management review.

  • Establishes, maintains and optimizes region wide processes related to metrics, management review, and training.

  • Supports APAC Quality Systems on strategic initiatives.

SUPERVISORY/MANAGEMENT RESPONSIBILITIES

None – individual contributor

POSITION ACCOUNTABILITY / SCOPE:

The position reports to the Regional (APAC) Quality Systems & Compliance Manager

MINIMUM EXPERIENCE / REQUIREMENTS:

  • Strong knowledge of relevant regulations for quality systems and compliance. Should have solid understanding of Quality Management System Principles.

  • Capable of analyzing data in order to support the development of strategies to effectively manage the action plans that will resolve the issues.

  • Proficient with Microsoft Office Suite (intermediate MS Excel knowledge required), Adobe Acrobat, Visio, PowerPoint presentation skills. Experience of using Track wise -SolTRAQ, ISOtrain, and General IT system data entry and report generation is desired.

  • Excellent verbal and written communication skills, interpersonal skills, and project management skills. Solid English language ability. Experience of working with people across geographies will be an added advantage

  • Minimum 7+ years of experience in the GMP/ Pharmaceutical industry.

  • Experience to include, writing and maintaining quality system documents.

  • Demonstrated problem-solving and decision-making abilities.

  • Ability to work independently with minimum supervision.

EDUCATION:

  • Bachelors in Pharmacy or equivalent Science degree required.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com