QA Specialist

at  MANFIELD EMPLOYMENT SERVICES PTE LTD

Singapore, Southeast, Singapore -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate06 Oct, 2024USD 6000 Monthly06 Jul, 20243 year(s) or aboveChemistry,Teamwork,Iso,Leadership Skills,Working ExperienceNoNo
Add to Wishlist Apply All Jobs
Required Visa Status:
CitizenGC
US CitizenStudent Visa
H1BCPT
OPTH4 Spouse of H1B
GC Green Card
Employment Type:
Full TimePart Time
PermanentIndependent - 1099
Contract – W2C2H Independent
C2H W2Contract – Corp 2 Corp
Contract to Hire – Corp 2 Corp

Description:

QA Specialist
Our client is a leading global manufacturer of polymer. They are currently seeking for QA Specialist to support and assist quality department.

The role of the QA Specialist includes:

  • Support and assist Assistant / QA or Quality Manager in managing AKSS QMS improvement initiative across all departments and functions to ensure quality initiatives and quality plans are executed and maintained in full compliance with IATF requirements. This includes addressing issues from quality management oversight and helping the site management team to effectively execute the quality enhancement activities.
  • Review batch release activities for production including but not limited to review of product grading records, analytical data, Certificate of Analysis (COA) and other documents as needed for consistency with applicable regulations and for compliance with AKSS Quality System. Approve these records when Assistant / QA or Quality Manager delegates accordingly.
  • Ensure the promotion of awareness of Quality Policy, Quality Objectives and Customer Specific Requirements (CSR) throughout AKSS organization.
  • Release, review and verify CAPA quality related issues (Raw Material, Finished Product, Shipment & Logistics issues) and ensure effectives of corrective actions. ETQ Administrator for CAPA and Document Control.
  • Review and update CSR (Customer Specific Requirement) and ensure all AKSS employee understand and conform to CSR by providing training and awareness.
  • Generate and review IATF / ISO procedures and Quality related procedures / instructions.
  • Generate & review Management of Change (MOC) for any change in critical parameters, raw material specification and finished product specification.
  • Generate Non-Regular Work (NRW) that will impact quality.
  • Drive Cpk improvement, review control charts, MSA and GR&R and recommend improvement action.
  • Drive FMEA and Control Plan generation and revision.
  • Manage IATF Core Tools (PPAP, APQP) documentation and reports.
  • Assist Assistant / QA or Quality Manager during plant audits (customer audit, external, internal and Supplier audit). Follow up completion of plant audit findings corrective / preventive actions
  • Lead Auditor for IATF / ISO Internal Audit and report nonconformity and recommends opportunities for improvement.
  • Support Assistant / QA or Quality Manager in handling customer complaint & investigation.
  • To make judgments in solving variances and help production in resolving issues related to quality.
  • Participates in R&D activities. Review Product Safety requirements from customers.
  • Provide QA/QC orientation to newcomers and provide Quality Awareness on periodic basis
  • Drive and apply risk management principles based on the analysis of context of organization, formulate goals and objectives to address risk and opportunities as part of organization strategy and performance indicators. Review and consolidate Contingency Plans and testing on periodic basis
  • Participate in R&D activities especially in new product launching and plant trial.
  • Provide CSR orientation to newcomer and provide IATF / ISO quality awareness on periodic basis.
  • Participate in Plant 5S / Housekeeping Initiatives and Safety Committee Meeting.
  • Participate in Production Meeting, Annual IATF / ISO Management Review, Quality Committee Meeting (QCM) and Production Quality Meeting (PQM).
  • Perform other delegated work assigned by Assistant / QA or Quality Manager

Job Requirement:

  • Degree in engineering or chemistry (BS Engineering / Chemistry / Science) or equivalent.
  • 3-5 years plus working experience in quality such as lab testing or in Quality Assurance department.
  • Knowledge and understanding of ISO 9001, IATF 16949 or similar quality systems and experience in facing quality audits.
  • Demonstrated leadership skills including teamwork, communication, prioritization and change management.

Other information:

  • Company bus provided
  • Fixed allowances including transport allowance, site allowance etc

Interested candidates, please send your detailed resume stating Past Employments, including Reasons of Leaving, Last Drawn Salary for the most recent 2 positions (breakdown of basic salary, allowance, bonuses etc), Expected Basic Salary and availability.

Responsibilities:

  • Support and assist Assistant / QA or Quality Manager in managing AKSS QMS improvement initiative across all departments and functions to ensure quality initiatives and quality plans are executed and maintained in full compliance with IATF requirements. This includes addressing issues from quality management oversight and helping the site management team to effectively execute the quality enhancement activities.
  • Review batch release activities for production including but not limited to review of product grading records, analytical data, Certificate of Analysis (COA) and other documents as needed for consistency with applicable regulations and for compliance with AKSS Quality System. Approve these records when Assistant / QA or Quality Manager delegates accordingly.
  • Ensure the promotion of awareness of Quality Policy, Quality Objectives and Customer Specific Requirements (CSR) throughout AKSS organization.
  • Release, review and verify CAPA quality related issues (Raw Material, Finished Product, Shipment & Logistics issues) and ensure effectives of corrective actions. ETQ Administrator for CAPA and Document Control.
  • Review and update CSR (Customer Specific Requirement) and ensure all AKSS employee understand and conform to CSR by providing training and awareness.
  • Generate and review IATF / ISO procedures and Quality related procedures / instructions.
  • Generate & review Management of Change (MOC) for any change in critical parameters, raw material specification and finished product specification.
  • Generate Non-Regular Work (NRW) that will impact quality.
  • Drive Cpk improvement, review control charts, MSA and GR&R and recommend improvement action.
  • Drive FMEA and Control Plan generation and revision.
  • Manage IATF Core Tools (PPAP, APQP) documentation and reports.
  • Assist Assistant / QA or Quality Manager during plant audits (customer audit, external, internal and Supplier audit). Follow up completion of plant audit findings corrective / preventive actions
  • Lead Auditor for IATF / ISO Internal Audit and report nonconformity and recommends opportunities for improvement.
  • Support Assistant / QA or Quality Manager in handling customer complaint & investigation.
  • To make judgments in solving variances and help production in resolving issues related to quality.
  • Participates in R&D activities. Review Product Safety requirements from customers.
  • Provide QA/QC orientation to newcomers and provide Quality Awareness on periodic basis
  • Drive and apply risk management principles based on the analysis of context of organization, formulate goals and objectives to address risk and opportunities as part of organization strategy and performance indicators. Review and consolidate Contingency Plans and testing on periodic basis
  • Participate in R&D activities especially in new product launching and plant trial.
  • Provide CSR orientation to newcomer and provide IATF / ISO quality awareness on periodic basis.
  • Participate in Plant 5S / Housekeeping Initiatives and Safety Committee Meeting.
  • Participate in Production Meeting, Annual IATF / ISO Management Review, Quality Committee Meeting (QCM) and Production Quality Meeting (PQM).
  • Perform other delegated work assigned by Assistant / QA or Quality Manage


REQUIREMENT SUMMARY

Min:3.0Max:5.0 year(s)

Pharmaceuticals

Production / Maintenance / Quality

Software Testing, Clinical Pharmacy

Graduate

Chemistry, Engineering

Proficient

1

Singapore, Singapore