QC Manager - Chemistry Lab
Thermo Fisher Scientific Jurong West
Job Description
- Promote a safety-first culture throughout the facility.
- Collaborate with the Quality Director and cross functionally 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, various regulatory like HSA, FDA and EU and company guidelines and regulations.
- Review and Approve the QC all documents like specification 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 schedules 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.
- 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.
- 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.
RecruitPedia Pte LtdJurong West
Job Description
Our Client is a Singapore based company in Medical Devices. Due to business needs, they are now recruiting a QC Supervisor to be part of their Quality team for ongoing transformation projects. They are located at West.
Duties of QC...
CytivaJurong West
to an altogether life-changing career.
Learn about the Danaher Business System which makes everything possible.
The Quality Control Specialist is responsible for managing a team of QC associates and ensuring that QC routine operations are carried out as per plan...
MIRXES PTE. LTD.Jurong West
and provider of accurate, actionable, and affordable microRNA-powered diagnostic tests.
Job Location: Tukang
Job Summary
The QC Supervisor will work as part of the Quality team to support the QC of day-to-day operations and maintain detailed records for all...