Position Summary
The QC Chemistry Laboratory Manager is leading all aspects of the quality control (QC) operations within laboratory. This role ensures that all activities align with regulatory standards and company policies, and ensure the on time results meets the cGMP regulations. Ensure that Quality control operations meets cGMP and Regulatory compliance and Data integrity principals while respecting regulations, corporate standards and clients requirements.
Responsibilities
- 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.
Requirements
- University degree in chemistry, biochemistry, or life sciences with shown experience in a pharmaceutical QC lab
- Minimum of 5 years in a leadership role in a QC Lab.
- Extensive background in drug production manufacturing, particularly in sterile environments.
- 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.
