Job Description

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 [Confidential Information] or simply click the button to APPLYNOW! We regret that only shortlisted applicants will be notified.

Chan Ku Ci - R22111446
EA License No: 16C8261