QA Engineer

1 week ago


Singapore PSC BIOTECH PTE. LTD. Full time

**PSC Biotech is looking for QA Engineer to support our client in Biopharmaceutical Industry for Media & Buffer; Incoming raw material & Commodities.
**Responsibilities**:

- Ensure that products manufactured meet approved company policies, processes and procedures.
- Provide quality oversight of GMP manufacturing and manufacturing support.
- Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/line-clearance activities and administration of Quality Logs, e.g. QA Hold, QA tag out.
- Release incoming material, process, and product batches.
- Participate in investigations arising out of non-compliance in incoming materials, media & buffer manufacturing processes.
- Perform regular walk-thru of manufacturing areas as required to ensure compliance is maintained at all times.

**Requirements**:

- Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering.
- This position requires knowledge of quality / compliance management as well as regulations and standards affecting APIs / Biologics.
- 2 to 5 years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment.
- Experience in SAP, Trackwise are preferred.
- Ability to quickly know products and processes in order to assess quality issues
- Total commitment to quality and maintain a high standard of work at all times
- Demonstrates the highest levels of integrity and a strong work ethic
- Good knowledge of GxP requirements and regulations
- Good planning and scheduling skills
- Good communication skills both verbal and written
- Good interpersonal skills
- **Must be comfortable with contract basis role**:

- **Able to start work within short notice


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