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Senior Biopharmaceuticals Manufacturing Executive
2 months ago
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.
- 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.
You will be based at one of our manufacturing sites in Singapore near Tuas.