เงื่อนไขการค้นหา

ประสบการณ์:

5 ปีขึ้นไป

ทักษะ:

Compliance, ISO 9001, ISO 14001

ประเภทงาน:

งานประจำ

• Oversee all quality-related activities and ensure effective implementation of DM s quality system.
• Drive continuous improvement using the Plan-Do-Check-Act (PDCA) methodology.
• Ensure customer satisfaction through consistent product and process quality.
• PLAN - Define Quality Strategy Ensure the Group Quality Policy is implemented, communicated, and understood within DM.
• Define DM-specific quality objectives aligned with group targets.
• Identify quality risks and improvement opportunities within DM.
• Collaborate with the QSM to ensure the DM processes are aligned with the Group Process Map.
• DO - Execute Quality Plans Document DM-specific processes and support documentation of group-wide processes.
• Train QA, QC, and SQE teams on ITPs and relevant technical quality documents.
• Lead training initiatives to build quality awareness across all DM departments.
• Foster a culture of quality by promoting a proactive, quality-minded approach among managers and staff.
• Ensure compliance with applicable standards (ISO 9001, ISO 14001, CARES, etc.).
• CHECK - Monitor Quality Performance Conduct internal audits in coordination with the QSM, aligned with applicable standards.
• Monitor and report key performance indicators (KPIs), audit results, and customer satisfaction.
• Maintain and update the plant's KPI dashboard.
• Lead the annual Management Review process.
• Support and facilitate second- and third-party audits (e.g., ISO 9001, ASME, ISO 19443, customer audits).
• ACT - Correct & Improve Coordinate corrective and preventive actions.
• Oversee investigations and resolution of customer complaints.
• Initiate improvements to address deficiencies and enhance process effectiveness.
• Supply Chain Quality Define raw material specifications and collaborate with SQAs.
• Participate in supplier evaluations and selection.
• Ensure purchase orders are issued to approved suppliers per validated specifications.
• Team & Resource Management Promote Dextra s vision, mission, and values throughout the organization.
• Assess and report on the resources required to implement the Quality Policy effectively.
• Define the QA department structure and maintain updated job descriptions.
• Monitor team performance and KPIs via PMS (Performance Management System).
• Identify competency gaps and implement development plans for QA team members.
• Document Control Center Management Oversee review, approval, registration, distribution, and archiving of controlled documents.
• Validate product documentation such as datasheets, assembly instructions, and quality manuals.
• Maintain and validate raw material specifications.
• Manage drawing records and control access to standards and technical documents.
• Nuclear Safety Ensure nuclear safety is prioritized above all other considerations.
• Apply a cautious, balanced approach to decision-making involving quality, cost, and schedule.
• Promote a culture of responsibility, accountability, and open communication.
• Ensure qualified personnel are assigned to key roles and empowered to raise safety concerns.
• Encourage a questioning attitude and challenge unsafe behaviors or decisions.
• Respond promptly and conservatively to any incident that could impact nuclear safety.
• Transparently report to the Board any issue potentially compromising nuclear.
• Qualification Requirements: Bachelor's degree or higher in Engineering or related field.
• At least 5 years working experience in Quality management position.
• Excellent written and oral communication is necessary.
• Computer skill (Microsoft office program).
• Statistical software skill (Minitab, SPSS).

ประสบการณ์:

2 ปีขึ้นไป

ทักษะ:

Compliance, Procurement, SAP

ประเภทงาน:

งานประจำ

• To manage raw material and packaging material team to stable production when to change manufacturing plan in production process.
• Follow up investigation, CAPA of any issues during using material in day-to-day manufacturing.
• To ensure and maintain compliance level of supplier (reject rate, complaint rate etc).
• To ensure that packaging material test results are checked, approved, recorded and available for inspection in accordance with Good Manufacturing & Control Laboratory Practices.
• To be responsible for maintain packaging material specification.
• Be responsible for all SOP related to packaging and raw material and safety.
• Co-ordinate with planning, production, warehouse, procurement, and quality team when raw material and packaging material encounter quality problem.
• To ensure that packaging material test results are checked, approved, recorded and available for inspection in accordance with Good Manufacturing & Control Laboratory Practices.
• To ensure recompilation for raw material is aligned with sampling card.
• Be responsible to pass and release all packaging material complied in SAP system.
• Coach and mentor less experience analyst and staffs; check the quality of their work and help them resolve problems.
• To supervise team to solve analysis issue and instrument operate issue.
• To ensure that equipment, instrument are maintenance, calibrated of packaging material in QC laboratory.
• Accountable for ensuring laboratory investigations are thorough and accurate and escalation of confirmed Out of Specification (OOS) and Out of Trend (OOT) results in line with global standards and any local SOPs.
• To provide effective application of analytical investigation and change management within QC as defined in SOPs.
• To maintain Raw material sampling following HALAL requirement.
• To understand and follow all necessary Health & Safety systems and ensure that work is consistent with safe working practices.
• To communicate with packaging team and AQL when packaging specification problem.
• To provide and support raw material and packaging material rejection report to production, warehouse, planning, and supplier.
• To review packaging material report, summarize monthly packing material rejection, Right at First time (RFT).
• Co-responsible for housekeeping, cleanliness, and safety in the laboratory, also responsible for taking care of laboratory facilities to keep them in good condition and ready for use.
• Perform other related jobs that may be assigned by the supplier or superior.
• To responsibility of Halal Management TeamDevelop and monitor manufacturing procedure of halal product to assure its consistency.
• Coordinate for test every incoming material in accordance with halal certificate, specifications, and manufacturer.
• Communicate with KAHI for each deviation and non-compliance of material and product in halal documentation.
• Deliver internal halal training to all internal department member.
• The experience we're looking for.
• Minimum 2 years experience in Quality Control and/or Assurance of manufacturing site and / or technical centre preferably within a multinational Pharmaceutical Business.
• Through knowledge of GMP requirements for API manufacturer (ICH7) and PS9000 standard for pharmaceutical packaging material.
• Broad understanding of Healthcare and Pharmaceutical manufacturing operations business including raw materials and packaging material manufacturing and control.
• Knowledge of Quality responsibilities, systems, and standards.
• Knowledge and experience of Good Manufacturing Practice and Regulatory standards.
• Supplier/3rd party/Distribution centre (WH) Quality Management.
• The skills for success.
• Flexibility in thinking and pragmatic problem-solving skills.
• Proven experience in multifunctional / multinational project management.
• Excellent communication skills with the ability to work on own initiative is essential for the success of this role. Be able to debate and negotiate with external supplier personnel.
• Well-developed influencing skills. Diplomatic and tactful in difficult supplier situation.
• Highly motivated and confident in external environments. Organised and able to deliver concise written or oral summaries to line manager.
• Able to lead improvement plans with key suppliers, requires a good manufacturing knowledge and an understanding of business process.
• Able to train and coach other auditors is preferably.
• SAP experience/knowledge will be advantage.
• What we offer.
• With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way. We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.
• Equality.
• We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you. All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.