Lisa Lin, M.Sc. Email & Phone Number

Richmond Hill, Ontario, Canada

• Manage and ensure compliance of process validation projects, communicating project status to management.• Review and approve validation documents to ensure compliance with TPD, FDA, EU, company SOPs, and other regulations.• Provide guidance on regulatory and process validation requirements for various departments.• Defend the process validation program during audits and ensure compliance with regulatory requirements.• Provide necessary support before, during, and after regulatory and customer inspections.• Prepare, execute, and maintain process validation documentation for Stage 2 and Stage 3.• Review and update Validation Master Plans for compliance with regulatory requirements.• Participate in teams/committees (e.g., new product launch, Change Control Board) to offer guidance on validation regulations.• Review and approve process validation documents and change controls, including Supplier Driven Changes.• Assist in developing, implementing, and training for SOPs, Technical Manuals, and Quality Policies related to process validation.• Ensure all process validation activities are coordinated with other departments to meet project timelines.• Lead risk assessments and recommend process improvement initiatives for efficiency and compliance.• Provide support to Lead Investigators and Project Leaders during failure investigations and investigation reports related to process validation.• Act as a resource for QA and other departments on validation-related issues.• Assume responsibilities of the manager or supervisor in their absence.

Etobicoke, Ontario, Canada

• Reported to the Associate Director of Global Quality Project Management, implementing projects within Global Quality Compliance and collaborating with global stakeholders to align with initiatives.• Supported regulatory compliance projects, including the global implementation of ICH Q3D, and authored Elemental Impurities Product Risk Assessments, formulating risk evaluations based on data and progressing identified CAPAs.• Executed all phases of projects within Global Quality, following Apotex's project management methodology, and defined project scope, goals, and deliverables with stakeholders.• Developed detailed schedules for execution tasks in collaboration with project team members, monitored project deliverables for quality, and ensured alignment with internal and client expectations.• Assisted in identifying and mitigating project risks, supported project closing activities, and maintained metrics on deliverables.• Managed project timelines by resolving issues and escalating unresolved matters, ensuring tasks remained on target for successful outcomes.

Cambridge, Ontario, Canada

• Conducted chemical and physical testing of injectable formulations, including APIs, excipients, and finished products.• Utilized analytical techniques such as HPLC, GC, ICP, UV-Vis spectroscopy, and titration to quantify and confirm the quality and stability of injectable drug products, including assay, pH, viscosity, and impurity profiling.• Performed stability studies on injectable formulations, analyzing the effects of temperature, humidity, and light exposure on product efficacy and safety, in accordance with ICH guidelines.• Played a key role in the validation of analytical methods for injectable products, ensuring robust and reliable testing procedures for regulatory submissions and quality control.• Supported product lifecycle management, including the review and approval of certificate of analysis, and regulatory submissions for new and existing injectable formulations.• Managed the verification and calibration of analytical instruments and laboratory equipment, ensuring compliance with GLP and cGMP.• Analyzed raw materials and in-process samples during production to ensure consistency and conformance to quality specifications, taking corrective actions when deviations occurred.• Performed container closure integrity testing on vials, syringes, and cartridges to ensure the sterility and stability of injectable products under various storage condition.• Led the investigation of OOS results, initiating root cause analysis and implementing CAPA to maintain product quality and prevent future deviations.

Markham, Ontario, Canada

• Managed and cultivated strong client relationships, acting as the primary liaison between clients and internal teams, ensuring the delivery of high-quality testing and laboratory services in alignment with client needs and expectations.• Provided expert guidance and support to clients in selecting appropriate testing services, advising on methodologies, timelines, and regulatory requirements, helping to ensure compliance with industry standards.• Prepared detailed and accurate quotations for clients, including cost estimates and service offerings, tailored to specific project requirements, and ensured alignment with client budgets and timelines.• Coordinated and tracked project progress, ensuring that all deliverables, timelines, and quality standards were met while maintaining regular communication with clients to provide updates and address concerns.• Collaborated closely with internal teams (scientists, QA, operations, business managers, and project managers) to customize testing solutions, optimizing service delivery for clients in sectors like pharmaceuticals and life sciences.• Managed the end-to-end process for quotations, from initial inquiry to final proposal, ensuring all aspects of the service agreement were clearly communicated and understood by both the client and SGS team.• Developed and delivered customized presentations and proposals, highlighting SGS’s capabilities and demonstrating value-added solutions to potential clients.• Contributed to revenue growth by identifying opportunities for upselling additional SGS services based on client needs and project scope, leading to expanded business relationships.• Ensured smooth project execution by aligning client expectations with operational capabilities, troubleshooting potential issues, and providing proactive solutions to maintain customer satisfaction.

Whitby, Ontario, Canada

• Conducted thorough reviews of documents and records for compliance with regulatory standards, company policies, and industry best practices.• Ensured that all QA documentation met cGMP and FDA requirements, maintaining a high level of accuracy and detail.• Reviewed batch records, change controls, deviation reports, and SOPs to verify completeness and consistency with internal protocols.• Collaborated with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to resolve documentation issues and ensure smooth operations.• Identified discrepancies and potential quality risks in documentation, recommending corrective actions and improvements to prevent non-compliance.• Supported audits by preparing and reviewing documents for internal and external inspections, contributing to successful audit outcomes.• Contributed to the development and implementation of new document control procedures, improving efficiency and compliance tracking.• Tracked and maintained documentation for regulatory filings, ensuring timely submission and proper organization of records.• Trained junior team members on document review processes and best practices to ensure high-quality work and continuous improvement.

North York, Ontario, Canada

• Performed all R&D activities under minimal supervision, including HPLC and GC method validation for new products, full testing of APIs, in-process, and finished products. • Conducted release testing, stability testing, in-process, and raw material testing according to specifications, as well as additional tests required for regulatory submissions.• Conducted lab investigations for OOS and OOT results.• Performed troubleshooting on complex issues and oversaw the resolution of project-related challenges.• Provided technical support to other departments for regulatory agency requirements and responses.• Fostered strong relationships within the team to ensure timely project delivery.• Delivered in-person training on LIMS and Empower for newly hired chemists from both R&D and QC labs across three GTA sites, while also assisting in the development of comprehensive training materials.• Acted as a key member of project teams and provided support to junior chemists.

Etobicoke, Ontario, Canada

• Prepared experimental and small-scale trials and batches according to approved project plans, protocols, or master formulas. Assisted senior technicians with optimization batches as needed.• Weighed, screened, and blended raw materials to produce trials, pilot, and submission batches for various dosage forms (e.g., compressed, enteric-coated, and film-coated tablets, capsules).• Dismantled, cleaned, and assembled rooms and equipment according to SOPs and Technical Manuals, ensuring cGMP compliance and meeting schedules.• Performed in-process physical tests on trials and production batches for weight, hardness, friability, disintegration, etc.• Troubleshooted out-of-normal situations using conventional problem-solving techniques and provided feedback to the supervisor.• Completed and signed off process documentation during batch execution, recording observations on product and process characteristics (e.g., powder flow, sticking, capping).

Honours Bachelor Of Science, Pharmacology

Master Of Science, Chemistry