Biopharmaceuticals Manufacturing Executive

4 weeks ago

Singapur, Singapore 825 Glaxo Wellcome Manufacturing Pte Ltd Full time

Job Summary:

The Career Conversion Programme (CCP) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore's Biopharmaceuticals manufacturing industry.

A certificate will be given to successful trainees upon completion of the programme.

Key Responsibilities:

  • Manage QC equipment life cycle from qualification to decommissioning including calibration and maintenance plan follow up
  • Manage new QC equipment qualification as per change control and validation processes
  • Be author of SOPs/protocols/reports/training materials
  • Manage decommissioning of QC equipment and follow disposal process
  • Maintain our QC asset listing up to date
  • Follow QC equipment routine lifecycle
  • Coordination of calibration and maintenance plan with user and external vendor/TS team
  • Coordination of equipment troubleshooting if occurrence of failure/breakdown
  • Sample transfer, alarm management and cleaning for fridges, freezers and incubators
  • Liaise with external vendor for service quotation, escort vendor during service and approve invoice timely
  • Supports compliance activities:
  • Performs regular Ll audits in QC
  • Coordinates and supports all L2, L3 and L4 audits and the associated CAPAs
  • Lead and manage continuous improvement projects Subject-matter-expert (SME)/audit fronter for assigned topics
  • Manage ad-hoc tasks

Organization and Management Responsibilities:

  • Creates strong team morale and a culture of accountability and ownership
  • Provides leadership, guidance and technical expertise/support to the juniors
  • Ensures continuous improvements of the QC operations
  • Ensures expenditures are within budget

Decision Making:

  • Proposals & Recommendations
  • Based on experience & knowledge of work
  • Proposal of CAPA for any issues/deviations/exceptions/risks
  • Proposal of QC improvement projects and strategies
  • Team training and development

Requirements:

  • For Specialist - University Degree in a relevant Science discipline with at least 2 years of working experience or Diploma with at least 5 years of working experience
  • For Senior Specialist - University Degree in a relevant Science discipline with at least 4 years of working experience or Diploma with at least 8 years of working experience

Skills:

  • Competent technical skills in project management
  • Computer system validation Knowledge of cGLP & cGMP
  • Effective report writing skills
  • Planning and Organizing skills
  • Good interpersonal and communication skills
  • Effective team player
  • Analytical skills with logical thinking Problem solving skills

Competencies:

  • Effective report writing skills
  • Planning and organization skills
  • Able to work independently
  • Team player
  • Analytical skills with logical thinking
  • Leadership skills (advantage)

Location:

You will be based at one of our manufacturing site in Singapore near Tuas.

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