Job Description

QA Specialist, Changi North - LKH

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.

Interested candidates, who wish to apply for the the above position, please click the \xe2\x80\x9cApply now\xe2\x80\x9d below and send in your resume to audrey_cheah@persolkelly.com

We regret that only shortlisted candidates will be notified. PERSOLKELLY Singapore Pte Ltd EA License No: 01C4394 EA Personnel No: R23117933 EA Personnel Name: AUDREY CHEAH KAI LI By sending us your personal data and curriculum vitae (CV), you are deemed to consent to PERSOLKELLY Singapore Pte Ltd and its affiliates to collect, use and disclose your personal data for the purposes set out in the Privacy Policy available at https://www.persolkelly.com.sg/policies. You acknowledge that you have read, understood, and agree with the Privacy Policy.

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