Biopharmaceuticals Manufacturing Executive
6 days ago
This programme is a manpower development initiative jointly supported by Workforce Singapore (WSG) and Temasek Polytechnic (TP). Upon completion, successful trainees will receive a certificate.
Purpose:- To provide technical support in QC Biological Team
- Assist the Superintendent/Manager in managing biological laboratory activities to ensure timely availability and accuracy of results
- Review and approve biochemistry/microbiological testing for utilities, raw materials, environmental, manufacturing processes, and products, ensuring compliance with corporate, regulatory, and external agency regulations
- Ensure all in-use procedures/policies/practices are current and compliant
- Maintain safety and security policies and practices
- Support equipment/software/method validation and perform revalidation when necessary
- Monitor results and issue corrective actions when required
- Provide technical expertise to ensure manufactured products meet applicable regulatory standards and guidelines for Quality Control operations
- Prepare and update LSOP/protocols
- Participate in investigation of non-conformities (deviations and exceptions) and close reports on time
- Perform data trending and coordinate with relevant parties
- Review QC reports to ensure compliance and promptness of results
- Problem-solving
- Identify and report problems in QC, solve problems, and implement corrective actions
- Presents major issues to management with strategies for resolution
- Organization and Management Responsibilities
- Assist the Superintendent/Manager in managing the Biological team
- Ensure appropriate training and development of the biological team, provide leadership, guidance, and technical expertise
- Create strong team morale and a culture of accountability and ownership
- Ensure continuous improvements of QC operations
- Science degree in Life Sciences, Biotechnology, Biochemistry, Microbiology, or equivalent with more than 2 years of working experience or Diploma holders with more than 5 years of working experience
- Competent technical skills in biological testing, laboratory equipment qualification, method validation, computer system validation, aseptic techniques, knowledge of cGLP and cGMP, and preferably statistics
- Effective report writing skills, planning and organizing skills, effective team player, analytical skills with logical thinking, good interpersonal skills, and leadership skills
- Good command of English and knowledge of computer usage
You will be based at one of our manufacturing sites in Singapore near Tuas.
How can I apply?Please refer to the company's website for application instructions.
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