Qc Specialist

4 days ago


Singapore ANTER CONSULTING PTE. LTD. Full time

About the Role
We are supporting a global pharmaceutical client in the setup and optimisation of their QC digital systems at a newly established API manufacturing facility in Singapore. This position focuses on supporting Empower Chromatography Data System (CDS) operations and related qualification and compliance activities within a GMP laboratory environment.

Key Responsibilities
- Support the implementation, configuration, and maintenance of Empower CDS for QC operations.
- Act as a key user or system administrator for Empower, including method set management, project structure, user access controls, and audit trail reviews.
- Participate in and support system qualification (IQ, OQ, PQ) and validation activities for Empower and associated instruments.
- Ensure data integrity compliance according to ALCOA+ principles and support audits and regulatory inspections related to Empower.
- Provide troubleshooting support for Empower-related issues in collaboration with QC, IT, and instrument vendors.
- Assist in drafting and reviewing SOPs, URS, functional specifications, validation protocols, and other system documentation.
- Support integration of Empower with lab instruments and data systems where applicable.
- Train QC analysts and other users on Empower usage, workflows, and compliance practices.

**Requirements**:

- Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or related field.
- Minimum 3-5 years of hands-on experience with Empower 3 in a GMP-regulated QC laboratory.
- Solid understanding of HPLC/GC workflows and how they integrate with Empower.
- Experience in system qualification or computer system validation (CSV) is a strong advantage.
- Knowledge of regulatory requirements (FDA, EMA, PIC/S) and data integrity standards (ALCOA+).
- Familiarity with related systems like LIMS, TrackWise, or Kneat is a plus.
- Strong documentation, communication, and cross-functional collaboration skills.


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