QA Automation Specialist focused on developing testing solutions for financial clients. Engage in full software development lifecycle utilizing automation and collaboration.
About the role
- Senior QA Pharmacist ensuring product quality and compliance in pharmaceutical manufacturing at Reckitt. Leading the product release process and driving continuous improvement initiatives.
Responsibilities
- Lead the finished product release process for the sales team, ensuring timely approval of products for distribution from Bangplee factory to the market.
- Perform finished product release for medicinal products in compliance with Reckitt Global Policy, Thailand Drug Act, EEA, Russian GMP, and EU GMP requirements.
- Act as the registered Thai Pharmacist for the Quality Department, listed in the Bangplee Factory Medicinal Product Manufacturing License, fulfilling responsibilities defined under the Drug Act of Thailand.
- Review all batch manufacturing and packaging records to ensure compliance with approved Optiva and PCS in TDS as per Reckitt document control standards.
- Drive Right First Time (RFT) and Turnaround Time (TAT) performance to meet KPIs and lead continuous improvement initiatives.
- Coordinate with cross-functional teams to ensure all product and process non-conformities are raised as deviation reports and resolved before product release.
- Ensure all changes are managed through the change control process, assessing quality impact on process, product, and regulatory compliance, and securing approvals prior to implementation.
- Participate as a member of the Quality Internal Audit Team for Bangplee factory in accordance with relevant SOPs.
- Develop and monitor GMP-compliant manufacturing procedures and data integrity practices to ensure consistency.
- Review and approve consumer and pallet unit formulas in PLM system, ensuring alignment with BPR and related documentation.
- Complete Good for Sale Certificates for new product launches.
- Conduct annual product quality reviews and management reviews.
- Ensure compliance with global quality standards, GMP, and regulatory requirements across all related procedures.
- Perform special projects and other related tasks as assigned.
Requirements
- Bachelor’s degree in Pharmacy and certified as a Thai Pharmacist under the Drug Act of Thailand.
- Minimum 5 years of experience in pharmaceutical manufacturing or quality assurance, with strong knowledge of GMP, GDP, PIC/S, ISO 13485, and regulatory standards.
- Proven leadership and people management skills, with the ability to influence and develop teams across all levels.
- Strong analytical and problem-solving skills, with flexibility and a pragmatic approach to challenges.
- Excellent communication skills in Thai and English (reading, writing, and speaking).
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and familiarity with SAP or PLM systems is an advantage.
Benefits
- 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.
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