Perform critical review of Batch documentation for aseptic processes for lyophilized products compounding, filling and packaging operations for completeness, Coordinate review with marketing partners, provide shipment authorization, File batch documentation Coordinate stability reports from CMO and updating marketing partners. • Manage change control process from CMO in accordance with requirements, review and approval of Change Controls, coordinate internal and external approvals as needed. Coordinate receipts of revised documents, filing and close out change controls. deviations, investigations to ensure adequate root cause analysis, OOS and OOT reports, Validation and Qualification reports. CAPAs for drug products. • Development and review of SOPs, Quality Agreements• Ensure SOPs are reviewed as per the established review period. • Review Annual Reports to ensure they are accurate and open AR changes are captured.• Maintenance of training records for all employees as per the established training curricula.• Manage Supplier Qualifications, manage audits (performed by external services) provide reports, manage CAPAs and audit close outs.• Pharmacovigilance: manage PV activities with external providers and marketing partners, monthly reconciliation, review of non-reportable MedWatch.

QUALITY CONSULTANT THRU RANDSTAD LIFE SCIENCES Quality Consultant for Radius Health Inc. Wayne PA Nov 2020 – June 2022• Review of Master and executed batch records, QC specifications, Testing Methods, QC testing documentation for release, Stability Protocols and Reports, Validation Protocols and Reports as it pertains to APIs and drug products. • Review and approval of Change Controls, deviations, investigations to ensure adequate root cause analysis, OOS and OOT reports, Validation and Qualification reports. CAPAs for APIs and drug products. • Assist in development of SOPs, Quality Agreements,• Assist in GMP audits of APIs and drug products

• Implement Overall Quality Systems, procedures, Standards. • Oversee Quality compliance in clinical trials, double blind studies, clinical deviation and implement appropriate corrective actions.• Represent Castle Creek as a Primary Quality Interface• Overseas all quality standards for investigational and commercial drug products manufactured for Castle Creek and maintains compliance with regulatory requirements as well as GMP Standards.• Fosters an environment of compliance and operational excellence• Lead external staff and stakeholders in all areas of Quality Operation: o FDA inspection readinesso Batch production and packaging record review, revision, dispositiono Implement requirements and guidelines for supplier quality selection, Design Quality Agreements, qualification, performance tracking, review and audits of contract manufacturers and laboratories. o Deliver GMP training and oversee the training curriculum and training metrics. o Provide guidance for oversight and batch disposition, quality excursions, OOT’s, OOS’s, Deviations, CAPAs as it may impact 3rd party manufacturer and laboratories. o Maintain Change Control database, review, approve and follow-up on Change Controls until completion. o Review and approve IQ/OQ/PQ, validation protocols, reports and packaging activities at all CMOs.o Review, approve, product specification, packaging specificationso Be the primary unblinded individual for all clinical studies. o Reviewed and released CMO Manufacturing batch records, dealt with deviations, CAPAs Change Controls, stability protocols reports for film-based pharmaceutical dosage forms (e.g. sublingual, buccal).

Develop and implement internal Audit schedule for Allendale NJ, Irvine CA and Mountain View, CA sites. Develop and implement Vendor Audit schedule. Manage Client audits for Allendale site. Manage CAPA system to ensure corrective and preventive actions are completed in timely manner.Interact with Allendale site personnel to ensure all GMP systems such as CAPA management, Change Control, Document Management and control are properly re-designed and are effective.

Area of Expertise: Pharmaceutical/ Medical Device Auditing | Process Validation and Qualification | Quality Improvement|

Managed internal audit function for five different Purdue sites, Supplier Quality Assurance division, R&D division as well as an affiliated API manufacturing unit. Prepared and executed annual audit schedules to cover all five FDA systems triennially plus identified sub-systems such as Change Control, Validation, Batch Records, Annual Product Reviews, Stability, complaint system, and training. Developed audit focus for each audit based on the current FDA 483s and GMP trends. Issued audit reports and rationalized and approved CAPA plans, issued quarterly evaluation reports for investigations, events, and monthly CAPA status reports for all sites. Developed and maintained Quality policies and standards for the manufacturing and R&D facilities.• Purdue compliance profile was significantly improved which was proven by recent two years US FDA as well as foreign regulatory inspections which resulted in insignificant or no audit findings. • Quality of Investigations and events processed by each Purdue site was significantly improved.

Quality System audit approach was utilized in conducting over 50 audits of Pfizer divisions and contract manufacturers, API manufacturers worldwide. • Accurately identified opportunities for improvement to maintain worldwide Pfizer standards.• GMP Audits and CAPA plan follow-up resulted in maintaining Pfizer Quality Standards and subsequently the quality of Pfizer products as per regulatory and Pfizer internal quality expectations.• Spearheaded development of Laboratory Quality System checklist which has been successfully used by the entire CQA department for worldwide audits of Laboratory system.

Performed worldwide GMP audits of BMS divisions, contract manufacturers, suppliers, API manufacturers, GMP and ISO 9000 audits of Mead Johnson Nutritional Division, ConvaTec, Zimmer and Clairol cosmetic divisions. • Development and application of Quality codes of practice throughout BMS divisions resulted in improved compliance profiles.• Streamlined audit approach to maximize use of all available resources • Provided technical support for identification and implementation of corrective actions and transfer of Best Practices.

Developed processes for manufacturing pharmaceutical dosage forms, scaling-up from laboratory to production scale and provided support to all manufacturing activities. Specific process development and scale-up of tablets, capsules, sustained released formulations, oral liquids, sterile injectables and semi-solid products. Provided technical support for commercial manufacturing of sterile products manufacturing including aseptically manufactured as well as terminally sterilized products, Oral Liquid Products and solid dosage forms. • Implemented process improvements that resulted in significant cost savings, reduction in cycle times and an increase in productivity.•Directed the efforts of various disciplines in establishing and validating processes in order to successfully implement new process technologies at various BMS manufacturing sites.•Successfully scaled-up, developed and conducted Process and cleaning validation studies for commercial processes for pharmaceutical production.•Compiled CMC sections for NDA submissions for new major BMS products which were subsequently approved by the FDA.