Career Conversion Programme

7 days ago

Singapore GLAXOSMITHKLINE BIOLOGICALS Full time
Roles & Responsibilities

The Career Conversion Programme (CCP) (Train-and-Place with Commitment to Hire) 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 in anticipation of hiring demand.


The training programme consists of 15 months of local attachment with GSK. Due to the nature of the programme, we can only consider Singapore Citizens and Singapore Permanent Residents. For more information, please visit Career Conversion Programmes (CCP) for Individuals.


Purpose:
  • To provide technical support to routine testing teams in the frame of the Analytical Science and Technology (ASAT) team around method development/ qualification/ validation/ verification and equipment qualification

Key Responsibilities:

  • Technical responsibilities
  • Manages and implement method development/ qualification/ validation/ verification and equipment qualification required by routine testing team, including but not limited to new equipment, material and method introduction and compendial updates
  • Keeps up-to-date on regulations/ development of biopharmaceutical QC activities to ensure QC operations are in compliance to applicable corporate, regulatory and external agency regulations
  • Leads/ manages investigation of non-conformities (events and deviations) and complex tasks (e.g. continuous improvements, department/ site projects and initiatives)
  • Knowledge management on knowledge retention and effective training to ensure methods/ knowledge are effectively transferred to routine testing team
  • Writes/ reviews change controls, events/ deviations, CAPAs and GMP documents (e.g. SOP, protocols, reports)
  • Provides technical expertise and consultation to routine testing team on technical matters to ensure compliance to applicable corporate, regulatory and external agency regulations
  • Subject-Matter-Expert (SME) audit fronter for assigned topics
  • Supports local compendium system
  • Performs review of compendium updates timely and accurately.
  • Supports investigation system in QC
  • Performs trends for invalids, atypical results and OOS
  • Problem Identification and Solving:
  • Identifies and reports problems in QC.
  • Recommends and coordinates a ro riate corrective actions as necessary
  • Organization and Management Responsibilities
  • Works with senior specialists/ chemists and manager to create a culture of accountability, ownership and continuous improvement
  • Respects all safety and security polices, laboratory policies and practices on site
  • Ensures expenditures are within budget
  • Works across boundaries across departments and/or sites
  • Works with senior specialists/ chemists and manager to align the priorities of the team with those of the department
  • Able to work independently, shows initiative and able to work with all levels of staff
  • Provides adequate guidance and technical support to other team when necessary
  • 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

Skills:

Professional

  • 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

Technical

  • Competent technical skills in the followings:
  • Common laboratory techniques (advantage)
  • Laboratory equipment qualification (advantage)
  • Method validation (advantage)
  • Computer system validation Knowledge of cGLP & cGMP
  • Preferably with knowledge of statistics (advantage)
  • Preferably with knowledge of compendium (advantage)
  • Preferably with knowledge of QC laboratory investigation (advantage)

Business

  • 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:

  • Good command of English
  • Good knowledge of Microsoft office
  • Attributes required of the job e.g. the ability to work independently; the ability to work in a team; shows initiative; able to work with all levels of staff Competencies must consider the key responsibilities, scope of accountabilities and required experience

Where will I be based?

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


Tell employers what skills you have

Report Writing
Anticipation
CAPA
Talent Development
GMP
Knowledge Management
Team Training
Problem Identification
Laboratory Techniques
Computer System Validation
Equipment Qualification
Decision Making
Laboratory
Writing Skills
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