QMS Specialist [Joo Koon | Pharma MNC | Up to $3800] RRKC

Job Summary

• US Pharmaceutical Company @ Joo Koon
• Monday - Friday, 8AM to 515PM
• 12-Months Contract
• Up to $3,800/month + 1-month bonus

Key Responsibilities

• Develop, review and maintain SOPs, work instructions and quality documents.
• Manage key QMS processes including Change Control, CAPA, document control and training.
• Ensure compliance with cGMP, regulatory requirements and company quality standards.
• Coordinate site self-inspections, internal audits and audit readiness activities.
• Support client and regulatory audits, including follow-up and closure of audit findings.
• Manage GMP training programmes and support employee qualification requirements.
• Conduct Product Quality Reviews (PQR) and quality trend analysis.
• Support supplier quality activities, including Quality Agreements and supplier evaluations.
• Monitor QMS activities and ensure quality events and actions are completed on time.
• Support data integrity and continuous improvement initiatives.
• Prepare quality metrics and reports for management review.
• Promote a strong safety and quality culture across the site.
• EHS Responsibilities
• Follow and promote workplace health, safety and environmental requirements.
• Understand and follow emergency procedures and safe working practices.
• Promptly report and support investigations of accidents, near misses and safety incidents.

Requirements

• Degree in Life Sciences, Chemical/Biochemical Engineering, Pharmaceutical Science or related fields.
• 2 years of Quality Assurance/Quality Management experience in the pharmaceutical industry preferred.
• Knowledge of cGMP, regulatory compliance and QMS.
• Experience in biologics, aseptic processes, data integrity or pharmaceutical manufacturing is an advantage.
• Good problem-solving and Quality Risk Management skills.
• Strong communication, coordination and teamwork skills

If you are keen to explore this career opportunity, kindly send a copy of your resume to [email protected] or simply click the button to APPLYNOW! We regret that only shortlisted applicants will be notified.

Chan Ku Ci - R22111446
EA License No: 16C8261