全职 Documentation Executive (Engineering) 工作, 薪水 up to MYR 3,000, SM PHARMACEUTICALS SDN BHD Kedah 公司招聘中 - Ricebowl

JOB REQUIREMENTS

• Diploma or Bachelor's Degree in Mechanical Engineering, Electrical Engineering, Mechatronics Engineering, Biomedical Engineering, Science, Pharmaceutical Technology or a related field.
• Fresh graduates are encouraged to apply.
• Candidates with 1–2 years of experience in pharmaceutical, medical device, biotechnology or manufacturing industries will have an added advantage.
• Knowledge of Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), Good Engineering Practice (GEP) and Quality Management Systems (QMS) is preferred.
• Familiarity with validation documentation, equipment qualification (IQ/OQ/PQ), calibration and preventive maintenance systems is an added advantage.
• Strong technical writing, documentation and record management skills.
• Proficient in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
• Experience with electronic document management systems (EDMS) or document control software is an added advantage.
• Good analytical, organizational and problem-solving skills.
• Able to work independently, manage multiple priorities and meet deadlines.
• Good communication and interpersonal skills with the ability to collaborate effectively across departments.
• High attention to detail, accuracy, integrity and commitment to compliance and continuous improvement.

JOB RESPONSIBILITIES

• Prepare, review and maintain all Engineering Department documents in accordance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and Company Quality Management System (QMS) requirements.
• Develop, revise and control Standard Operating Procedures (SOPs), Work Instructions (WI),
• Preventive Maintenance (PM) procedures, Engineering Change Requests (ECR) and other engineering-related documentation.
• Coordinate document preparation, review, approval, issuance, revision and archival while ensuring proper document version control.
• Prepare and maintain validation documentation, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), equipment qualification protocols, reports and utility validation documents.
• Maintain preventive maintenance schedules, calibration records, equipment history files, maintenance logs and engineering documentation to ensure compliance with GMP requirements.
• Support engineering projects, equipment installation, commissioning, qualification and validation activities by preparing and controlling the required documentation.
• Coordinate closely with Engineering, Production, Quality Assurance (QA), Quality Control (QC),
• Regulatory Affairs, Warehouse and other departments to ensure documentation accuracy and timely completion.
• Maintain both electronic and hardcopy filing systems to ensure all engineering records are secure, traceable and readily retrievable during audits and inspections.
• Ensure all controlled documents comply with Company policies, regulatory requirements and document control procedures.
• Monitor document review schedules and ensure obsolete documents are withdrawn and replaced with the latest approved versions.
• Assist in investigations related to deviations, corrective and preventive actions (CAPA), change control and risk assessment documentation.
• Prepare engineering reports, equipment performance summaries, maintenance KPIs and departmental documentation as required by Management.
• Support internal audits, customer audits, ISO audits, GMP inspections and NPRA regulatory inspections by providing accurate engineering documentation.
• Participate in continuous improvement initiatives to enhance document management systems and engineering processes.
• Maintain confidentiality of all engineering documents, technical information and Company intellectual property.
• Perform any other duties assigned by Management.

Pay: RM2,000.00 - RM3,000.00 per month

Benefits:

• Meal allowance
• Opportunities for promotion
• Professional development

Work Location: In person