• Support process development, manufacturing and clinical operations by assisting in theimplementation and maintenance of quality systems that ensure compliance with internalstandards and expectations and regulatory requirements.Partner with Production, Facilities, Quality Control, Clinical Operations, ProductDevelopment and other functions in ensuring high quality products and compliance withcurrent Good Manufacturing Practices (cGMPs) and Good Clinical Practices (GCPs).• Train junior quality assurance staff and oversee their daily tasks and schedules.• Prepare and lead regularly scheduled quality meetings with internal stakeholders from otherfunctions.• Identify, remedy and escalate any gaps or non-compliance with quality and regulatorystandards to Associate Director of QA.• Drive continuous improvement efforts on Quality and cGMP operations.• Review Polices, Standard Operating Procedures (SOP), Master Batch Records, Forms,Reports, and equivalent documents for compliance to internal procedures and external GxPregulations.• Oversee the release of Raw Materials and disposition of nonconforming materials.• Lead the implementation and management of electronic quality management system.• Manage Quality Systems including, but not limited to change control, document control,training, deviations and CAPA.• Support and advise cGMP Operation functions on nonconformance investigations,qualification of cGMP equipment and systems, method transfers, and change control.• Participate in quality risk assessments of internal operations to analyze risk and identifymitigations.• Assist in the conduct of internal and external audits to ensure cGMP compliance.• Understand and comply with company standard operating procedures and safetyprocedures.

• Working in an FDA, ISO 13485 and GMP environment for a healthcare packaging. • Provided engineering and technical solutions relate to process deviations for daily functions in manufacturing using Lean Manufacturing Principles. • Write, execute and prepare report for validation protocol for various product codes and equipment (IQ, OQ & PQ) in addition to process changes or experimentation/validation of new product.• Lead/manage project through cross functional teams for startup efforts and assist different Continuous Improvements (CI) projects that reduced cycle time and waste production/material.Quality Process Engineer (additional roll):• Communication – Establish in first place of communication immediately with various customer/supplier regarding any quality issues that bear elevated risk to the business and customer.• Customer complaint handling, product disposition, immediate actions, corrective & preventative actions and CAPA for all non-conformance.• Supplier’s SCAR handling and open claim review and provide status to the corporate.• Participate and support all on-site customer audits, including ISO and FDA audits.• Documents control, update-approve new revision and provide training to personnel or new hires. • Establish and maintain relationships with operations, customer account managers, engineering, quality teams, and cross functional personnel to identify compliance gaps with proposed resolutions for improvement.

• Protocol writing, execution and reports for the equipment (refrigerators/freezers/coolers) validation• IQ/OQ/PQ protocol writing,preparation and execution• DI water system validation, execution and reports• 3GEM UM system validation and process studying

•Supported all Quality Assurance and Validation functions in order to ensure that the concepts, designs, specifications, implementation and maintenance of new and existing GXP regulated systems follow standard operating procedures, industry standards and practices with a primary focus on Process, Cleaning and Equipment Qualification and Computer System Validation•Attended project team meetings and prepared specifications and protocols to support development batches for line trials and new products pipe line•Experienced with the latest validation guidelines and regulatory expectations by reviewing protocol and report•Reviewed the Validation Plan, Qualification Protocol (IQ/OQ/PQ) and Final Summary Reports•Prepared quarterly Annual Drug Product Reviews (ADPR) reports and Change Control assessments•Participated in Remediation Plan for both Process and Cleaning Validation to find and resolve the compliance gaps•Assisted with process improvements for the Facility Validation Program and provided support for Quality Systems investigations, CAPAs, and NCs

•Performed on daily QARM operations per GMP regulations including following detailed SOPs, maintain accurate inventory management, deviation reporting, and good documentation practices•Performed vendor audits, laboratory audits and general cGMP compliance audits•Worked in multiple databases and experienced with query and documentation using electronic database systems •Reviewed documents for the sampling and inspection of incoming materials used in the production of pharmaceutical products.•Prepared labeling and packaging materials inspection reports•Supported GMP functions such as QC, supplier quality management, materials dispensing, manufacturing•Experienced in Amgen Quality Systems ( SAP, LIMS, CCMS, Trackwise, EDMQ)

•Performed with Supporting Marketed Product (SMP) groups responsible for both Process Validation and Cleaning Validation , preparation/review protocols, documents, and executing the validation batches for both new and old products•Followed the Validation Life Cycle approach for all new products, product transfers and any subsequent validation activities•Reviewed and executed the PV & CV Protocols, Reports and MWI’s•Involved to investigate all protocol deviations and non-conformances associated with PV & CV activities•Conducted annual process validation reviews/process history summary (PHS) for OTC Monograph product•Performed execution of Filling and Packaging validation process for new and old products in the different filling/packaging lines•Reviewed all documentation generated by Process, Cleaning and Fill/Pack Validation activities•Provided training to all manufacturing personnel on the PV,CV and Fill/Pack Protocols and the MWI’s•Ensured that the PV & CV program comply with all cGMP and FDA requirements

• Monitored product quality through the performance of required visual and functional testing• Performed initial review and verification of executed batch records, product related forms, files, protocols/reports and other cGMP related documents • Performed in corrective and preventive action(CAPA), Deviation programs and conduct cGMP audits • Handled customer complaints in timely manner. This include internal audits and assist during customer and FDA audits• Reviewed procedure for Yokogawa (Paperless Recorder Review) data for Lyophilizers, using DAQSIGNIN application software• Performed in FMEA(Failure Mode and Effect Analysis) and KAIZEN programs on AHF-M fill failure investigation/identification of root causes, determined optimal cycle time, use of capacity and standardized process steps