Job Description

Description

• Able to lead project for Method validation/verification/transfer to introduce new/remediated QC methods for testing existing and new products independently
• 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
• 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 * Able to lead project for Analytical Equipment Qualification to qualify/ re-qualify QC equipment for testing existing and new products independently

• 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 procedure

• Ensure timely release of equipment to support commercial production
• Ensure RFT in the equipment qualification process
• Maintain validated status of equipment
• Support QC Method launch activities with QC and other sites/functions
• Coordinate QC method documents changes for regulatory submission
• Author of regulatory submission documents e.g. Consolidated (Test) Validation Report (CVR) and MoH responses
• Perform trending for laboratory invalid assays
• Lead and drive invalid results and trend violation investigations independently
• Site SME of global procedure for Invalid results which involves conducting local training and communication with global procedure owner
• Lead method-related investigations for unexpected results independently
• Support Site SME of global procedure for unexpected results in conducting local training and communication with global procedure owner
• Work in investigation involving other sites/functions
• Prepare control assignment Protocol/Report for controls as required.
• Support Site SME of global procedure for critical materials in conducting local training and communication with global procedure owner
• Lead and drive control trend rule violation investigations independently
• Coordinator of new/revised compendial document assessments on local methods and raw material
• Ensure assessments is performed in a timely manner
• Track the actions defined to be implemented as required.

Requirements

• Experience in GMP
• Experience in QC equipment qualification such as writing protocol
• Basic knowledge on regulatory requirement on equipment qualification
• Strong Project Management skill
• Good verbal and written communication skills
• Min Degree in Chemistry, Biochemistry, Biotechnology or Diploma in Chemistry, Biochemistry, Biotechnology.
• A minimum experience of 3-5 years in Pharmaceutical, Biopharmaceutical or related manufacturing environment.

For interested candidates, please send your most recent and updated resume to michelle.lee@recruitexpress.com.sg
Subject heading: QC Specialist

Michelle Lee Ser Min
Recruit Express Pte Ltd
(R1440070)
EA Licence No. 99C4599

Industry

Healthcare / Pharmaceutical / Life Science / Medical Device

Specialization

Healthcare - Nurse / Allied Healthcare
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 Michelle Lee Ser Min.
CEI Registration No.: R1440070
Email: michelle.lee@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