Job Description

Description

Project Management: Analytical, Raw Material and Microbiological Method Introduction

• Project Lead for Method validation/verification/transfer to introduce new/remediated QC methods for testing existing and new products
• Subject matter expert in method validation, verification and transfer; covering wide arrays of methods and complex techniques
• Author of Method validation/verification/transfer Protocols, Reports, Reports, ensuring GMP compliance in ICH Q2(R1), USP

1225
, USP
1226
, EU GMP Chapter 6, and WHO Annex * Ensure timely release of methods to support commercial production, manufacturing investigations and product investigations

• Ensure RFT in the method introduction process
• Maintain validated status of assays by establishing a control and monitoring strategy to ensure that the method is in the state of control, and the data generated from the method is reliable.

Project Management: Analytical Equipment Qualification

• Project Lead for Analytical Equipment Qualification to qualify/ re-qualify QC equipment for testing existing and new products
• Subject matter expert to provide technical advice to Local QC in laboratory related troubleshooting, e.g. lab equipment failure
• Author of equipment qualification documents as indicated in global procedures
• Ensure timely release of equipment to support commercial production
• Ensure RFT in the equipment qualification process
• Maintain validated status of equipment

Education and Experience Requirements

• Degree in Chemistry, Biochemistry, Biotechnology or Diploma in Chemistry, Biochemistry, Biotechnology with 1-2 years of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment.
• Demonstrated experience e.g. in the area of method validation, method transfer, method verification, Unexpected Results investigation.
• Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.

TELE me at @jacechooo or WA me at NOW!
Interested candidates please submit your resume to jacechoo@recruitexpress.com.sg

Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)

Industry

Healthcare / Pharmaceutical / Life Science / Medical Device

Specialization

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

Location

North

Employment Type

Contract / Temp

Salary

Negotiable

If you meet the requirements of this role, please email a detailed resume in Word document to Jace Choo Oi Kei.
CEI Registration No.: R1875164
Email: jacechoo@recruitexpress.com.sg
Tel: 67363280
*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.

Recruit Express