QS Specialist Qualification & Validation
About the Role
We are seeking a detail-oriented Quality Specialist to support the Chief of Quality Systems in maintaining robust quality systems across the site. This role focuses on qualification and validation lifecycle management to ensure compliance with GMP, GDP, and applicable global regulatory requirements.
You will collaborate closely with cross-functional teams to ensure equipment, facilities, processes, and computerized systems meet regulatory expectations and internal quality standards while driving continuous improvement and operational excellence.
Key Responsibilities
Qualification & Validation Compliance
- Serve as the Quality SME for qualification and validation across equipment, utilities, facilities, computerized systems, processes, and cleaning.
- Provide quality oversight for IQ/OQ/PQ and validation activities (process, cleaning, analytical, and computerized systems).
- Review and approve validation documentation including VMP, URS, DQ, FAT/SAT protocols, traceability matrices, and validation reports.
- Ensure validation activities comply with cGMP requirements (e.g., EU GMP Annex 15, EudraLex Vol. 4, 21 CFR Part 11).
- Assess and approve change controls impacting validated systems and determine requalification or revalidation requirements.
- Review supplier/vendor qualification packages before release of equipment or systems for routine use.
- Lead or support risk assessments (e.g., FMEA, HAZOP) to define validation scope and critical parameters.
- Ensure validation documentation complies with data integrity principles (ALCOA+) and is inspection-ready.
- Maintain validation lifecycle management including periodic reviews and continued process verification (CPV).
Quality Systems Management
- Support the deployment and maintenance of key quality systems including CAPA, Change Control, Supplier Qualification, and Material Management.
- Act as the site representative for DigiQual quality modules (Deviation, OOS/OOT, CAPA, QV, etc.).
- Provide training and ongoing support to system users.
- Guide stakeholders in establishing effective CAPAs and Change Controls aligned with SMART principles.
- Track and ensure timely completion of CAPAs and change controls.
- Maintain the approved supplier list and support supplier qualification processes.
- Contribute to quality KPI reporting, management reviews, and annual product quality reviews.
Audit & Inspection Support
- Act as a Quality subject matter expert during internal and external audits and regulatory inspections.
- Support audit preparation, execution, and follow-up activities.
- Participate as a site auditor for internal audits when required.
- Coordinate responses to audit observations and track audit-related CAPAs.
Quality Compliance & Continuous Improvement
- Develop and maintain quality SOPs and documentation aligned with company standards and regulatory expectations.
- Stay updated on relevant global regulatory guidelines (e.g., ICH, EU GMP, US FDA, Thai FDA).
- Support GMP and documentation practice training to strengthen site quality culture.
- Identify opportunities to enhance validation practices and quality system efficiency.
Qualifications:
- Bachelor's degree in Engineering, Pharmaceutical Sciences, Applied Sciences, or a related discipline
- Licensed Thai Pharmacist preferred
- Minimum 5 years of Quality experience in a GMP-regulated environment, including at least 3 years in qualification and validation oversight
- Demonstrated experience reviewing and approving IQ/OQ/PQ protocols for manufacturing equipment, utilities (e.g., HVAC, purified water), laboratory equipment, and cleaning validation
- Strong understanding of cGMP regulations and global regulatory requirements (e.g., EU GMP, US FDA, ICH, ISO)
- Experience with Computer System Validation (CSV) and GAMP 5 guidelines is an advantage
- Familiarity with risk-based validation approaches (e.g., Lean Validation, ASTM E2500) is a plus
- Excellent technical writing, analytical, and problem-solving skills
- Strong organizational and time management skills in a fast-paced regulated environment
- Proficient with Microsoft Office tools (Word, Excel, PowerPoint) and statistical tools such as Minitab
- Strong communication and interpersonal skills with the ability to collaborate across cross-functional teams
- Self-motivated, detail-oriented, and able to work effectively in dynamic environments
- Professional English communication skills (written and spoken)
- Flexibility to provide occasional off-hours support for GMP operations
