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Reckitt

Senior QA Pharmacist Release

ประกาศจากแหล่งภายนอก
Reckitt
สุขภาพ / เภสัช
สมุทรปราการทำงานที่ออฟฟิศลงประกาศ 91 วันที่แล้ว
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เกี่ยวกับตำแหน่ง

As a Senior QA Pharmacist, you will lead the release of Reckitt products from the Bangplee factory, ensuring compliance with global and local regulatory standards. This role involves reviewing manufacturing records, managing deviations, and leading a team to maintain product quality and safety.

รายละเอียดงาน

About the role

The overall purpose of the job is to guarantee and improve the quality of Reckitt products leaving the factory by setting, improving and auditing the most economically efficient Quality systems, in line with the Global Quality Policy / Manual, Global and local procedures, and the requirements from the Global Health Quality Management Organisation.

Your responsibilities

  • Leading release for sales team to perform finish product release in order to approve product for sales from Bangplee factory to distributor in market.
  • To perform finish product release for sales of medicinal product according to Reckitt Global Policy and Drug Act of Thailand including EEA and Russian GMP.
  • To perform finish product release for shipment of medicinal product according to EUGMP.
  • To react as registered Thai Pharmacist of Quality Department and listed in Bangplee Factory Medicinal Product Manufacturing License as per responsibility defined in Drug Act of Thailand.
  • Review all batch manufacturing and packaging record from production to ensure that the product was produced and comply with current approved Optiva and PCS in TDS as Reckitt document control.
  • To lead RFT and TAT to drive to meet with KPI and improve with drive team to achieve target.
  • To coordinate with all cross functional team in Bangplee Factory to ensure that all non-conformity for both product and process have been raising to be deviation report as per deviation reporting system and in Quality Approved status before release product.
  • Review all batch manufacturing and packaging record from production to ensure that the product was produced and comply with current approved Optiva.
  • To perform finish product release for sales of Medicine product according to Reckitt Global Policy and Drug Act of Thailand.
  • To coordinate with all cross functional team in Bangplee Factory to ensure that all change need to raise as change control as per Bangplee SOP and all actions defined according to the change control system need to be close and get the change control approval before implementation and product release.
  • To be assessment change control to defined any quality impact for process, product and regulatory are relate with Bangplee site.
  • To be a part of Quality Internal Audit Team for Bangplee factory according to relevant SOP.
  • Develop and monitor manufacturing procedure of GMP and data integrity to assure its consistency.
  • To review and approve consumer and pallet unit formula in PLM system which relate BPR and other document.
  • To complete Good for Sale Certificate for new product launch.
  • To responsibility for annual product quality review and management review.
  • To ensure comply with global quality standard and GMP & Regulatory requirement which related procedure.
  • Perform special projects and other related job assigned.

The experience we're looking for

  • Bachelor degree in pharmacy and certified as Thai Pharmacist according to Drug Act of Thailand
  • 5 years experience in related field
  • Familiarity with GMP, GDP, PIC/S, ISO13485 and other Standard requirements
  • People management to proven experience in leading managing and developing teams, able to influence people of all levels
  • Flexibility in thinking and pragmatic problem
  • Be able to communicate English both reading, writing and speaking.
  • Knowledge and experience of Good Manufacturing Practice and Regulatory standards.

The skills for success

Commercial Awareness, Business Partnership, Collaboration, Partnership building, Ability to challenge the status quo, Propose improvement, Accountability, Adaptability, Collaborator, R&D, Product Lifecycle Management.

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.

สวัสดิการที่ได้รับ

วันลาคลอด / ดูแลลูกประกันชีวิตอบรม / พัฒนาทักษะParental benefitsEmployee assistance programLife insuranceGlobal share plansShort-term incentives

คุณสมบัติผู้สมัคร

ประสบการณ์
3-5 ปี
การศึกษา
ปริญญาตรี
ใบรับรอง / ทักษะเพิ่มเติม
Quality assurancePharmacistGMPGDPPIC/SISO13485Regulatory compliancePeople managementProduct lifecycle managementBatch record reviewInternal auditingData integrityCommercial awarenessBusiness partnershipProblem solving
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English· คล่อง

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