Job Description

Description

Salary: Up to $6.2k

Duration: 6 months (May be renewable/ convertible)

Job Scope:

• Responsible to review and approve master batch records and subsequent batch records associated with the manufacturing, packaging and labeling of intermediates and active pharmaceutical ingredients (API) to ensure batches produced are in compliance with quality standards and regulatory registered specifications
• Disposition the intermediates and active pharmaceutical ingredients
• Review and approve cleaning records and procedures and ensure compliance with the Quality Standards (PQS) and guidelines.
• Review and approve GMP documentation and ensure their compliance to Quality Standards (PQS).
• Ensure adherence to quality procedures, regulatory requirements and cGMPs.
• Improve quality assurance systems, as necessary.
• Review and approve deviations according to the site procedures.
• Reviewing and approving the investigation reports, ensuring the adequacy of the associated corrective actions and/or preventive actions, performing the impact assessment with the subject matter experts for quality/validation/regulatory impact.
• Ensure issues are escalated according to the Quality Standards (PQS).
• Handle product complaints.
• Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.
• Coordinate with cross-functional team to prepare Annual Product Record Reviews, discuss trends and atypical observations and recommend improvement actions.
• Conduct external audits to ensure adequate oversight to suppliers and collaborate with supplier to reduce starting material quality issues.
• Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
• Support the maintenance of validated stated of GMP systems and processes.
• Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner
• Qualify and manage suppliers according to Quality Standards (PQS) and maintain accurate records of supplier status.
• Review and analyze the quality related issues from suppliers and recommend improvement action to mitigate compliance risk.

Job Requirements:

• Min. Diploma/ Degree in any relevant field
• Min. 2-3 years relevant experience in GMP/ Manufacturing
• Able to start immediate/ within a short notice preferred

Industry

Healthcare / Pharmaceutical / Life Science / Medical Device

Specialization

Chemist / Research Scientist
Healthcare - Pharmaceutical / Life Science / Medical Device / Clinical Research / Regulatory Affairs

Location

West

Employment Type

Contract / Temp

Salary

S$2,601 - S$4,000 / mth
S$4,001 - S$6,000 / mth

For interested applicants, please send your updated resume to: melissa@recruitexpress.com.sg

All candidates\' information will be treated with the strictest confidence

Melissa Zhang Zhiqi (Mezzo)

R2197564

Recruit Express Pte Ltd

99C4599

Recruit Express