QC S&T Analyst (Pharma/Biotech)

NUSANTARA PRIME CONSULTING PTE. LTD.; Singapore; On-site; SGD 40,000 - 60,000; Full time

Job summary

A leading consulting firm in the pharmaceutical industry, based in Singapore, seeks a Quality Control professional. Responsibilities include supporting laboratory operations and compliance with regulatory requirements. Candidates should have a degree in a science discipline and 1-3 years of relevant experience. This position is contract-based with a length of 12 months, with an option to extend based on performance.

Qualifications

• Minimum 1 - 3 years of pharmaceutical experience in a Quality Control Function.
• Experienced in Regulatory/Pharmaceutical requirements.
• Basic GMP knowledge/Experience on QC Lab Equipment and Method transfer.

Responsibilities

• Support laboratory operations and infrastructure.
• Participate in management of QC laboratory equipment.
• Author and execute qualification documents in compliance.

Skills

Analytical thinking

Basic problem solving

Good communication skills

Team collaboration

Education

University Degree in Science related discipline

Tools

Empower

LIMS

SAP

Job description

Responsibilities

• Supports team task to support laboratory operation and infrastructure in the areas of examples: Equipment, Data Systems, Method) needs
• Participates in the management of laboratory equipment and computerized systems in QC laboratory to ensure business continuity and system data maintenance e.g., Empower, LIMS, SAP and equipment maintenance/calibration is in a state of compliance
• Participates in method technology transfer and laboratory equipment technological refresh/introduction activities into QC Laboratory within project timeline
• Participates in QC laboratory long range planning to ensure laboratory infrastructure needs is secured and Data integrity plan is in place to support business and laboratory compliance
• Author and execute qualification and equipment qualification documentation / method transfer (E.g.: Reports, Protocol, change control, related quality documents or procedures) are in cGMP compliance to corporate/site or regulatory requirements
• Supports and ensure timely escalation/handling of lab events or related quality actions. (E.g.: NCR, Lab Investigation, CAPA)
• Supports preparation and participate in internal/external audit, audit responses, to enable a successful audit outcome
• Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable. Lead/supports CI initiatives to enable laboratory performance metrics
• Carry out any other task as assigned by Line manager

About You

• University Degree in Science related discipline (E.g.: Chemistry, biology, pharmaceutical sciences, or equivalent experiences)
• Minimum 1 - 3 years of pharmaceutical experience in a Quality Control Function
• Experienced in Regulatory/ Pharmaceutical requirements
• Analytical thinking with basic problem solving and writing skills
• Motivated and independent
• Basic GMP knowledge/Experience on QC Lab Equipment and Method transfer
• Good communication skills and Strong ability to work cross functional teams
• Ability to work towards timeline
• Based in Tuas

Job Type: Contract

Contract length: 12 months. Option to extend/convert subject to performance review.