Senior QA Pharmacist Release
We are Reckitt
Research and Development
In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.
We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
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
What we offer
Equality
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