Salary: up to $8000
Duration: 6 months
Working Days & Hours: Mon-Fri Office Hours
Location: Kranji
Job Description:
Support Site Manufacturing (Upstream/Downstream) Activities Through:
- Planning and executing activities required for process investigation such as performing process impact assessment, participating and performing root cause analysis. Work with cross functional teams for process issues investigation
- Analyzing process trends, monitoring process performance as part of the CPV program. Escalate and perform investigation in event of any out of trend or process issues
- Leading process investigations to identify root cause and implement action plans to correct or prevent re-occurrence
- Planning and executing process improvements and robustness projects
- Leading/supporting cycle development for process parameters where applicable
- Drafting process training slides and providing process training to cross functional teams
- Raising change controls as change owners for process changes
- Performing impact assessments for relevant change controls
- Providing technical /process parameters for creation and revision of master batch records. Review master batch records.
Lead/Support Technology Transfer for New Technologies/Product Introduction Through:
- Leading/Supporting the evaluation of new manufacturing technologies and/or equipment for process improvement or process capabilities build
- Planning and executing technical transfer activities according to project timelines. Raise change controls where applicable to support the technical transfer
- Monitoring process performance and trending through the site CPV program. Proactively investigate where required to ensure process robustness.
- Performing risk assessment, drafting required technical transfer and process control strategy documents and updating lifecycle documents
- Authoring study and process validation protocols and reports where needed
Others:
- Support audits, regulatory submissions and responses
- Support and execute global manufacturing sciences initiatives according to project timelines
- Responsibility to adhere to any applicable EHS requirements.
- Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.
- Any other duties as assigned by supervisor.
Job Requirements: Min Degree in Biochemistry, Chemistry, Chemical Engineering, Biotechnology, Biochemical Engineering with minimum 3 - 4 years of relevant experience in pharmaceutical industry
Interested candidates, please submit your resume to: [email protected]
Ally Audrey Lok Xin Woon
Recruit Express Pte Ltd (Healthcare & Lifescience)
Company EA Licence number : 99C4599
Personnel EA License: R21102307
