Job Responsibilities
- Conduct analytical method transfer, validation, verification, and equivalency studies in compliance with SOPs, ALCOA principles, and data integrity standards.
- Perform analytical testing in accordance with GMP and GLP requirements, ensuring accuracy and efficiency.
- Lead or participate in 5S and housekeeping initiatives, maintaining adherence to safety procedures.
- Assess product impact due to changes or updates in compendial monographs.
- Support regulatory submissions and respond to queries related to post-transfer activities.
- Write and review SOPs, OJT materials, protocols, reports, test procedures, and position papers.
- Investigate laboratory incidents, identify root causes, and implement appropriate CAPAs.
- Provide hands‑on training to colleagues on instruments and analytical methods.
- Review and approve laboratory test results.
- Manage QTS actions and handle GMP‑impacting change controls.
- Coordinate with donating sites to facilitate smooth method transfers.
- Conduct training on new laboratory methods for QC team members.
- Contribute to continuous improvement initiatives within QC or cross‑functional teams.
- Actively participate in Tier meetings by updating performance metrics, highlighting issues, and supporting solution development.
- Perform cleaning method development and validation.
- Ensure documentation complies with GDP practices and is accurately maintained.
- Execute method verification per site or pharmacopeial standards on schedule.
- Keep training records current and properly filed to reflect testing qualifications.
- Adhoc tasks and projects as assigned
Job Requirements
- Minimum Degree in a related discipline
- Minimum 2 years of relevant quality check experience
- Experience within the Pharmaceutical industry would be an added advantage
- Able to start immediately or within short notice
Interested candidates, kindly email your detailed resumes in MS word format to joseph.koh@ambition.com.sg
Attention to Joseph Koh Wei Jie (R1873431)
Shortlisted candidates will be notified
www.ambition.com.sg
EA Registration Number: R1873431
Data provided is for recruitment purposes only
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