Biopharmaceuticals Manufacturing Executive
7 days ago
825 Glaxo Wellcome Manufacturing Pte Ltd is seeking a highly skilled Biopharmaceuticals Manufacturing Executive to join our team. As a key member of our Analytical Science and Technology team, you will be responsible for providing technical support to routine testing teams in the development, qualification, validation, and verification of analytical methods and equipment.
Key Responsibilities:- Manage and implement method development, qualification, validation, verification, and equipment qualification required by routine testing teams.
- Keep up-to-date on regulations and developments in biopharmaceutical QC activities to ensure compliance with corporate, regulatory, and external agency regulations.
- Lead and manage investigations of non-conformities, events, and deviations, as well as complex tasks such as continuous improvements, department/site projects, and initiatives.
- Knowledge management and effective training to ensure methods and knowledge are effectively transferred to routine testing teams.
- Write and review change controls, events/deviations, CAPAs, and GMP documents, including SOPs, protocols, and reports.
- Provide technical expertise and consultation to routine testing teams on technical matters to ensure compliance with corporate, regulatory, and external agency regulations.
- Subject-Matter-Expert (SME) audit fronter for assigned topics.
- Support local compendium system and perform review of compendium updates timely and accurately.
- Support investigation system in QC and perform trends for invalids, atypical results, and OOS.
- Problem Identification and Solving:
- Identify and report problems in QC.
- Recommend and coordinate corrective actions as necessary.
- 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 common laboratory techniques, laboratory equipment qualification, method validation, computer system validation, knowledge of cGLP & cGMP, and preferably knowledge of statistics, compendium, and QC laboratory investigation.
- Effective report writing skills, planning and organizing skills, good interpersonal and communication skills, and analytical skills with logical thinking and problem-solving skills.
- Good command of English and good knowledge of Microsoft Office.
As a Biopharmaceuticals Manufacturing Executive at 825 Glaxo Wellcome Manufacturing Pte Ltd, you will have the opportunity to work in a dynamic and challenging environment, with a competitive salary and benefits package. You will also have the chance to develop your skills and knowledge in a rapidly evolving industry, with opportunities for career growth and professional development.
We are an equal opportunities employer and welcome applications from diverse candidates. If you are a motivated and experienced professional looking for a new challenge, please submit your application.
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