QA Specialist, Changi North
2 weeks ago
Our client is a leading Regional Distribution Center (RDC) for a pioneering regional consultancy and bio-logistic services division of a pharmaceutical company. They provide customized, value-added bio-logistics for pharmaceutical, clinical trials, medical devices, diagnostics, hopsitals and other related companies.
Currently they are sourcing for the role of QA Specialist.
Working Hours : Monday - Friday, 8.30am - 5.30pm
Working Location : Changi North
Tranport Provided: Company transport will be provided at designated pick up points in Woodlands, Yishun, Ang Mo Kio, Seng Kang, Pasir Ris & Tampines.
Responsibility:
- Check and approve repackaging requirements of products and materials according to Client and regulatory requirement. Full review of batch records to ensure compliance per the repackaging instruction and GMP standards.
- Verify correct execution of repackaging activity against approved / updated repackaging instructions.
- Perform required quality checks and create quality inspection lots in SAP.
- Record Inspection Results and perform Usage Decision and stock posting. Issue necessary documents to facilitate release.
- Authorize to stop any repackaging activities when deviation is observed, when necessary.
- Perform other QA release (e.g. inbound QA release, cold chain temperature release, outbound release) if required.
- Perform back-up and other duties as assigned.
- Perform QA sampling, inspection and release of incoming packaging materials.
- Filing and maintenance of packaging material specifications.
- Updating of logs and trackers as required.
- Ensure general cleanliness and hygienic conditions of each workstation.
- Ensure compliance to ISO procedures, GxP and all regulatory requirements.
- Work closely with inter-departments personnel to ensure quality is maintained throughout the organization.
- Conduct internal audits, training and general communication to achieve and sustain a high level of quality performance throughout the organization so as to properly support the business and regulatory (ISO, GMP, GSDP) requirements in the most efficient manner.
- Support QA administrative functions when necessary.
- Participate in any ad hoc projects as assigned by management from time to time.
**Requirements**:
- Diploma in any related discipline or good knowledge in Quality / Compliance areas in manufacturing can be considered.
- Preferably relevant experience in Quality Control / Quality Assurance works in manufacturing / production / assembly / operation environment.
- Knowledge in ISO, GMP and GSDP preferred.
- Quality-oriented.
- Demonstrate integrity and strong work ethic.
- Good team player with good verbal and written communication skills in English.
- Meticulous with good attention to details.
- Must be able to work in a fast-paced environment.
- Willing to work in cold room environment to perform cold chain QA release.
- Willing to work flexible and extended hours on weekday, weekend and public holidays to support operations and depending on the exigencies of service.
- Able to start immediately.
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