Job Description

Description

:

• Head of the quality department (QA, QC & Laboratory)
• Establish & monitor Quality Management System (QMS) for compliance of current GMP, PIC/s, ASEAN guidelines, USFDA, pharmacopeia & other regulatory requirements.
• Ensure all documents of QMS are up-to-date, trained, distributed, implemented & continuously improved.
• Manage change control & impact assessment for all changes in QMS.
• Manage all deviations, conduct impact assessment, investigations & close-out with CAPA.
• Work with cross-functional teams to make risked based decision & resolve operational quality issues.
• Ensure all verification, calibration, qualification & validation are conducted on production machines & analytical instruments.
• Liaise with suppliers for quality issues, conduct supplier audit & assess supplier quality performance.
• Evaluate & approve of new materials, suppliers, contractors & outsourced activities.
• Lead internal audit, external audit & ensure the non-conformities are closed-out.
• Present Product Quality Review & Management Review to management team.
• Assist management team in define & implement Quality Policy & Objectives at all levels in company.
• Liaise with subsidiaries for change control, quality issue & corporate quality standards.
• Conduct GMP Training & ensure other QMS trainings are conducted accordingly.
• Ensure Good Documentation Practices for documents retention, traceability & retrievability.
• Manage recall, return, customer complaint, counterfeit & conduct mock recall.
• Review Batch Process Records & approve to release incoming materials, Work-In-Progress & finished products for the absence of QC Manager / QC Specialist.
• Reject materials & suspend production when quality is affected.
• Supervision of laboratory activities for GLP compliance & productivity review.
• Ensure work safety & healthy environment in quality department.

Requirements:

• Minimum bachelor\'s degree in Pharmaceutical, Bioscience, Chemical or related courses.
• Minimum 5 years of working experience in GMP environment.
• Working knowledge of GLP, GMP & ISO.
• Hands-on experience in equipment qualification & validation will be an advantage.
• Positive working attitude.

If you are interested in the position, do kindly drop your most updated resume to (Attn: QC Manager)

Thank You.

Lynn Ho

R23114223

Recruiter\'s Ref Code: #HHO

EA License: 99C4599

Industry

Healthcare / Pharmaceutical / Life Science / Medical Device
Others
Semiconductor / Electronics / Engineering

Specialization

Engineering
Healthcare - Pharmaceutical / Life Science / Medical Device / Clinical Research / Regulatory Affairs
Professional Services

Location

Central, North, East, West

Employment Type

Contract / Temp
Permanent

Salary

S$1,501 - S$2,600 / mth
S$2,601 - S$4,000 / mth

If you meet the requirements of this role, please email a detailed resume in Word document to Lynn Ho Lin Ying.
CEI Registration No.: R23114223
Email: lynnho@recruitexpress.com.sg

*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.

Recruit Express