QC Manager - Chemistry Lab

Thermo Fisher Scientific; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A global life sciences company in Singapore seeks a leader for its QC laboratory. The role includes promoting safety, managing audits, ensuring compliance with regulatory standards, and developing staff. Candidates should have over 5 years in a leadership role within a quality control environment and a degree in a relevant science field. Strong knowledge of QC chemistry techniques is essential, along with effective communication skills.

Qualifications

• 5-years in a leadership role in QC Lab.
• Proficient with regulatory expectations including PICS, ICH, Singapore HSA, EMA, and US FDA.

Responsibilities

• Promote a safety-first culture throughout the facility.
• Lead internal audits, data integrity surveillance, regulatory inspections, and customer audits.
• Coordinate testing processes of Raw materials and other samples.
• Implement data integrity principles throughout QC processes.

Skills

Strong technical knowledge of QC chemistry techniques

Excellent interpersonal and communication skills in English

Effective cross-functional partnership

Education

University degree in chemistry, biochemistry, or life sciences

Tools

HPLC

UPLC

CE

Job description

Responsibilities

• Promote a safety-first culture throughout the facility.
• Collaborate with the Quality Director and cross functionally with each department along with site leadership to improve QC laboratory quality culture.
• Lead QC laboratory budget and initiate cost control measures.
• Ensure comprehensive training for staff, covering skills, analyst qualification, cGMP, and safety.
• Lead internal audits, data integrity surveillance, regulatory inspections, and customer audits.
• Coordinate timely and approved testing processes of Raw materials, Drug substance, Packaging materials, Drug product and other utilities samples. Project delivery of method transfer and validation as a part of technology transfer.
• Ensure strict adherence to cGMP, regulatory bodies like HSA, FDA and EU and company guidelines and regulations.
• Review and approve the QC documents such as specifications, methods and other protocols.
• Identify and address gaps in lab management and operations when regulations and pharmacopoeia update.
• Lead timely resolution of laboratory investigations and deviations.
• Report quality metrics and schedule projects to meet timelines.
• Implement data integrity principles throughout QC processes.
• Hire, develop, and lead QC Chemistry professionals. Further team growth and address performance issues.
• Mentor and empower team members to achieve functional objectives.

Experience

• 5-years in a leadership role in QC Lab
• University degree in chemistry, biochemistry, or life sciences with shown experience in a pharmaceutical QC lab.
• Proficient with regulatory expectations including PICS, ICH, Singapore HSA, EMA, and US FDA.

Proficiencies

• Strong technical knowledge of QC chemistry techniques (HPLC, UPLC, CE, etc.).
• Expertise in analytical method validation and transfer as per Pharmacopoeia.
• Familiarity with testing protocols, analytical instrumentation, and sterile manufacturing and biologic-specific methodologies.
• Excellent interpersonal and communication skills in English.
• Effective cross-functional partnership within the organization.