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    Roles & ResponsibilitiesThe 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...

Senior Biopharmaceuticals Manufacturing Executive

2 months ago


Singapore 825 Glaxo Wellcome Manufacturing Pte Ltd Full time

Job Summary



The Career Conversion Programme (CCP) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals aims to develop the next generation of skilled manpower for Singapore's Biopharmaceuticals manufacturing industry in anticipation of hiring demand.



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



Key Responsibilities


  • Technical Responsibilities
  • Manages and implements method development/qualification/validation/verification and equipment qualification required by routine testing team, including 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 with 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 with 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 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 policies, 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 members 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.

Requirements


  • 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.
  • 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), Compendium (advantage), and QC laboratory investigation (advantage).
  • Effective report writing skills, Planning and Organizing skills, Good interpersonal and communication skills, Effective team player, Analytical skills with logical thinking, Problem solving skills.
  • 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.

Where will I be based?

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