Senior QA Lead – Pharma Compliance & Release

Xepa-Soul Pattinson (Malaysia) Sdn Bhd; Malacca City; On-site; MYR 120,000 - 190,000; Full time

Job summary

Xepa-Soul Pattinson (Malaysia) Sdn Bhd is seeking a QA Specialist to certify product releases and ensure all batches are manufactured and checked in line with MA and GMP requirements. The role involves leading the review of BMR/CoA/Analytical Reports, supporting annual quality reviews, and overseeing complaint investigations.

The candidate will participate in audits, maintain E-tools for quality systems, and drive risk-based quality processes across manufacturing operations, ensuring continuous

Qualifications

• Degree in Pharmacy with minimum four years working experience in QA/QC
• Fresh graduates in Pharmacy or in Chemistry/Microbiology/Science/Engineering considered for junior roles
• Experience managing QA programs in pharmaceutical manufacturing is preferred
• Strong knowledge of ISO and PIC/S regulations and cGMP is required
• Excellent English communication, both written and spoken

Responsibilities

• Appointed as AP to certify product release and ensure batches meet MA and GMP requirements
• Lead product release, review BMR/CoA/Analytical Reports and system releases
• Support annual product quality review and trending analyses with improvement plans
• Assist in complaints and product recall investigations with governance processes
• Investigate deviations and propose CAPA with root cause analysis and effectiveness checks
• Investigate root causes in stability studies and ensure preventive actions
• Assist in audits (internal, regulatory, customer, certification bodies)
• Act as E-tools custodian under IT support for quality systems
• Contribute to Risk Management integration into quality systems
• Support Change Control, impact assessment, and action verification
• Coordinate reprocessing and re-inspection activities and maintain in-house specs
• Support Post Market Surveillance and management reviews
• Prepare SOPs, site master plan, and quality policy deployment
• Contribute to Stability Study Management Program documentation and reports
• Propose and execute quality improvement programs with robust evidence
• Report anomalies/deviations/non-conformances promptly
• Perform other duties as assigned

Skills

Interpersonal communication

Planning & organizing

Attention to detail

Critical thinking

Microsoft Office

Education

Bachelor’s degree in Pharmacy

Degree in Chemistry/Microbiology/Science/Engineering

Tools

ISO & PIC/S regulations

Job description

Xepa-Soul Pattinson (Malaysia) Sdn Bhd is seeking a QA Specialist to certify product releases and ensure all batches are manufactured and checked in line with MA and GMP requirements. The role involves leading the review of BMR/CoA/Analytical Reports, supporting annual quality reviews, and overseeing complaint investigations.

The candidate will participate in audits, maintain E-tools for quality systems, and drive risk-based quality processes across manufacturing operations, ensuring continuous