Quality Engineer
Alcon • Batam, Riau Islands, Indonesia
**Role & seniority: ** Quality/Compliance Engineer (entry-level; ~1–2 years experience preferred), may involve leading tasks in investigations/CAPA and overseeing operations.
**Stack/tools: **
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GxP computerized systems lifecycle compliance (assessment of direct/indirect GxP applicability)
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Validation/qualification documentation and execution/approval
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Quality risk assessment methods (risk assessments)
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Non-conformance systems: investigation, RCA, CAPA
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Change Request (product/process improvement)
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Quality oversight at operations (incl. computerized system oversight)
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Top 3 responsibilities:
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Execute/lead Non-Conformance investigations, perform RCA, and generate/execute CAPA; communicate outcomes/disposition and escalations.
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Support and review validation/qualification studies for products/processes/raw materials/computerized systems; ensure compliance with lifecycle requirements for computerized systems and data.
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Perform risk assessments and support Change Requests; conduct periodic quality/computerized system oversight and compliance improvement program involvement.
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Must-have skills:
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Experience with Non-Conformance, RCA, and CAPA
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Validation/qualification support for products/processes/raw materials and/or computerized systems
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Risk assessment capability and change control support
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Strong stakeholder communication (English verbal/written), guidance to QA/Manufacturing/MST& Engineering
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**Nice
Full Description
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Assist/Execute/Lead Non-Conformance Investigation, RCA, and the generation/execution of CAPA.
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Review/execute engineering studies/validation/qualification activities for new/existing product/process/raw material/computer systems.
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Perform risk assessment for product/process and system.
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Support/lead Change Request for any product/process improvement.
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Conduct quality oversight at the operation area on a periodic basis.
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Communicate issues related to product quality, disposition of non-conforming products & escalations.
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Support and involved in Compliance Improvement Program.
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Work with manufacturing to implement process improvements.
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Perform assessment, determines GxP applicability (Direct/Indirect impact) of the system.
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Conduct quality oversight for the computerized systems at the operation area on a periodic basis.
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Ensure compliance with lifecycle requirement for Computerized System and its data.
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Review/Execute/Approve validation/qualification activities for new/existing computerized systems.
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Ensure compliance and provide guidance plus technical support to QA/Manufacturing/MST& Engineering.
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Work in-accordance with HSE manual and documented procedures, and reporting HSE issues.
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Leveraging good practices by referencing other Alcon sites.
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Review historical quality performance (non-conformance, customer complaint, escalation) from other Alcon sites.
Qualifications
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Bachelor's degree in Engineering or a Science-related field.
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1-2 years of relevant work experience are preferred.
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Experience handling Non-Conformance investigations, Root Cause Analysis (RCA), and Corrective and Preventive Actions (CAPA).
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Experience supporting validation and qualification activities for products, processes, raw materials, and/or computerized systems.
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Strong communication and stakeholder management skills.
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Good verbal and written communication skills in English.
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