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.
