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Batch Record Creation Lead
Job summary
A biotechnology firm in Singapore is seeking a qualified candidate to lead multiple Change Records and support manufacturing operations. Responsibilities include developing projects to ensure compliance with GMP regulations and facilitating process improvements. Ideal candidates will have a Bachelor's degree in a relevant life science field and experience in a GMP environment. Strong communication skills in English are essential.
Qualifications
- Bachelor's degree in biology, biotechnology, or biochemistry.
- Experience in a GMP environment is preferred.
- Ability to work independently or as part of a team.
Responsibilities
- Lead and execute multiple Change Records for Batch Records and SOP.
- Support Change Records Assessment and GMP documentation Review.
- Coordinate and facilitate small to medium manufacturing projects.
Skills
Education
- Lead and execute multiple Change Records (Planned events) for the assigned area for creation of new Batch Records and Standard Operation Procedures for Production
- Support Change Records Assessment and GMP documentation Review.
- Responsible for providing support to the assigned manufacturing operations by developing, coordinating and facilitating small to medium projects to ensure planned, predictable production operations in compliance with GMP regulations.
- Lead and execute Continuous Process Improvements, CAPAs and Change Records in assigned area
- Provide routine and ad hoc support for planning, coordinating, execution, and performance improvement of key manufacturing processes such as product change over.
- Lead project teams to trouble shoot medium to complex problems and support continuous process improvement. Facilitate root cause analysis (RCA) with input from SMEs, develop and implement change to improve performance.
- Collaborate with multidisciplinary teams to achieve project objectives.
- Assist in experimental design and troubleshooting as needed.
- Bachelor's degree in a relevant life science field (biology, biotechnology, biochemistry).
- Previous experience in a GMP environment is preferred.
- Strong attention to detail, organizational skills, and the ability to work independently or in a team.
- Excellent communication skills, both written and verbal, in English.
- Adherence to safety protocols and regulatory compliance.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.