Ed Chan Email & Phone Number

Waltham, Massachusetts, Us

Ardelyx, March 2020 - Present• Project planning on product launch, work through packaging project changes and manage deliverables, follow ups on action items.• Represent client as packaging lead at CPO meetings. Drive closure of documents and deviations.• Review and approve all packaging related documents, including packaging validation, specifications, master batch records, and other cGMP documents.

Bridgewater, New Jersey, Us

• Led, tracked and managed Technical Transfer activities at Contract Manufacturing and Packaging Organizations (CMOs and CPOs.• Collaborated with CMOs on manufacturing process development. Reviewed and approved technical transfer and compliance documents, include process development and validation, master batch records, hold time studies, equipment qualification (IQ, OQ, PQ) and change controls. • Supported investigations on manufacturing and packaging deviations.• Delivered a Product Improvement project, which yielded an annual cost savings of $2.5 million.• Completed Serialization packaging validation projects at eleven (11) CPOs.• Achieved FDA approvals on seven (7) technical transfer multiple strengths products.

Hayward, Ca, Us

• Oversaw quality and compliance of medical device (Epinephrine auto-injector) products, included QA review and release/approval of third-party batch records and compliance documentation (consist of qualification, validation, change control, and deviation investigation). • Collaborated and provided validation strategies and assembling process optimization.• Validated a semi-automated, assembling and packaging line with vision inspection system, with deliverables consisted of URS, FS, SDS, TM, FAT, IQ, OQ, and PQ.

Hayward, Ca, Us

Amedra Pharmaceuticals, January 2013- July 2013• Ensured quality of medical device (Epinephrine auto-injector) products at CMOs by reviewing deviations, batch records, validation, change controls, and other compliance documentation.CorePharma, August 2011- January 2013• Executed qualification and compliance remediation programs. Deliverables comprised of change controls, qualification protocols, and final reports (IQ. OQ, PQ), CAPAs and Quality Investigation Reports. Collaborated and developed Qualification Periodic Review procedures.

Us

• Directed a team of six (6) to Manage the site validation and quality system programs.• Ensured validation/qualification documentation, including computerized system validation, equipment and utility qualification, cleaning, and process validation, met all regulatory agency and SOP requirements.• Oversaw the site Change Control program. Led the harmonization of the change control process across the U.S. and Puerto Rico sites.• Participated in regulatory (FDA) inspections.• Authored or reviewed and approved standard operating procedures.• Performed and approved deviation reports to ensure thorough investigations, and the CAPAs addressed the root causes of the deviations.• Tracked, prepared, executed, and approved Corrective Actions and Preventative Actions (CAPAs) and Effectiveness Checks that addressed root causes of deviations or audit observations.• Monitored and maintained plant employee training in the electronic training system.• Represented QA in Technical Transfer Project team to provide compliance guidance on project execution and reviewed/approved all technical transfer documentation.• Provided solutions to technical and tactical issues, on projects, and day-to-day plant supports.• Coached direct reports on technical and interpersonal skills. • Chaired weekly site metrics meeting with Plant Ops and QA management to discuss and track plant metrics.

Us

• Facilitated the enhancement of the company commissioning and validation program.• Reviewed and approved equipment commissioning, qualification and computerized system validation documentation for manufacturing and packaging equipment, utility systems and cGMP computerized control systems, such as master plan, URS, SDS, IQ, OQ and PQ.• Reviewed and approved process validation protocols and reports on solid and liquid oral dosage products.• Defined guidelines and standards on company validation programs.• Managed the central internal audit program, involved planning and executing internal audits followed by tracking of corrective actions.• Prepared gap assessments and provided compliance guidance and hands-on support on remediation projects.• Participated in CMO external audits to support Contract QA group.

• Planned, supervised, and executed the site validation programs. Managed validation consultants on projects.• Authored/executed or reviewed/approved master plans, protocols and reports for process, cleaning, equipment and utility (IQ, OQ, and PQ) validation.• Managed the site cleaning validation program by working with Planning, Manufacturing and Quality on scheduling, swab sample collection, training, testing, and documentation.• Led the validation of Bulk Pharmaceutical Chemical Manufacturing Area renovation project.

Biotechnology And Biomanufacturing Certificate

Ms, Medicinal Chemistry

Bs, Chemistry, Economics