INDUSTRY CONSULTANT 4/2011 – PRESENT
Consultant –Lupin Pharmaceuticals, Bhopal, MP India (11/2019– 9/2020)
- Assessment and remediation of manufacturing process of multiple oral suspension products to determine source of product variability in response to FDA observation.
- Retrospective review of manufacturing data, Quality Management System documents (APQR, Change Control, Test Methods, Raw Materials, Deviations, Investigations, OOT/OOS, CAPA, etc.) and Process Validation documents to determine gaps in accordance with current regulatory guidelines and expectations.
- Conduct laboratory and manufacturing investigations to determine root cause of deviations and OOS/OOTs.
- Implement remediation for the gaps identified to meet regulatory standards utilizing statistical analysis and scientific rationale.
- Floor monitoring of remediated manufacturing process to ensure that the batch record, process validation protocol, sampling and testing is appropriately followed.
Consultant –Pharmasol Corporation, BOSTON, MA (9/2019– 10/2019)
- Assessment and remediation of Quality Management System and manufacturing process in response to FDA Warning Letter.
- Review deviations, investigations for aerosol products including but not limited to process, packaging, materials, chemistry, microbiology, data integrity, personnel, and procedures.
- Ensure CAPAs are appropriate and effective to ensure that discrepancies are not repeated ensuring timely closure of investigations
Consultant –JUUL SAN FRANCISCO, CA (4/2019 – 9/2019)
- Liaison for JUUL Quality organization at contract manufacturing sites. Ensure appropriate product testing and release data meeting quality specifications.
- Assist in determining the root cause of product and process deviations and implementing optimized corrective actions to prevent reoccurrence.
- Ensure that the equipment and process utilized in the manufacturing of JUUL products are of adequate design and validation is conducted with acceptable results.
Consultant – Jubilant Generics Ltd., Roorkee, Uttarkhand, India (4/2019 – 6/2019)
- Conduct evaluation of company investigations, deviations, batch rejects, critical effects, including operations investigations, laboratory out-out-specifications (OOS) investigations. Laboratory-out-of-trend (OOT) investigations, and laboratory incidents/analytical interruptions related to solid dose products.
- Evaluation includes Operations/Laboratory investigation that are associated with batch rejects and critical defects, Laboratory investigation associated with OOS results generated, regardless whether the results were invalidated by a laboratory investigation, OOS results interpreted as “atypical events” and laboratory investigations associated with laboratory incidents and analytical interruptions.
Consultant - PFIZER India, VISAKHAPATNAM, AP, India (8/2018 – 2/2019)
- Deviation and investigation coaching and mentoring of quality and manufacturing investigators of a major multi-national biopharmaceutical organization in accordance corporate standards, policies, and site procedures.
- Author and review deviations, OOT/OOS and investigations for injectable products including but not limited process, sterilization, packaging, materials, chemistry, microbiology, data integrity, personnel, and procedures.
- Perform root cause analysis utilizing statistical and continuous improvement principles and tools.
- Ensure CAPAs are appropriate and effective to ensure that discrepancies are not repeated.
- Ensure timely closure of investigations to ensure supply of products to the market and patients
Consultant - Wockhardt Pharmaceuticals, AURANGABAD, MH & ANKLESHWAR, GJ, India (9/2016 – 7/2018)
- Retrospective and prospective batch record review of API and finished products (manufacturing and analytical data) as a third party focusing primarily on data integrity and emphasis in compliance to established processes. Ensure adherence to Good Documentation Practices.
- Review of quality systems including but not limited to deviations, CAPA, change control, LIRs, investigations, protocols, regulatory notification, etc. associated with manufacturing and product testing.
- Review of analytical data included but not limited to compliance with laboratory procedures, test methods and current record of analysis, in-depth review of LIMS data to ensure appropriate test sequence (blank, standard and sample injections) and correct product profile is used. Evaluation of data sources and traceability to ensure that instrument input is properly processed and data generated is accurate and safely archived.
- Laboratory shop floor monitoring to ensure compliance to standard operating procedures, use of appropriate analytical test instruments (HPLC, GC, UV, Dissolution instrument, etc.), standards and reagents and instrument calibration and preventive maintenance are current.
- Manufacturing and laboratory shop floor monitoring to ensure compliance to standard operating procedures, batch record and Good Documentation Practices.
- Mentoring of personnel in writing deviations, CAPA, change control, LIRs and investigations.
- Pharmaceutical Quality Systems Assessment and Remediation. Review of company policies, site procedures and programs to identify gaps and non-compliance. Collaborate with stakeholders to remediate gaps including managing timelines and personnel for deliverables for the remediation process.
Consultant – MYLAN INDIA, Bangalore, KA & Hosur, TN, India (9/2015 – 4/2016)
- Pharmaceutical Quality Systems Assessment and Remediation
- Facilities, Equipment and Utilities Qualification
- Aseptic equipment, cleaning and process validation
- Sterile environment monitoring and qualification
Quality Systems Lead (Consultant), IMPAX LABS, Hayward, CA (2013 – 7/2015)
- Primary contact and responsible for representing Impax quality organization in the development and implementation of the Corporate Quality Manual, Policies and Standards in compliance with regulatory and statutory requirements. Reported to the Sr. Director of Regulatory Compliance.
- Responsible for remediating Impax Change Control system. Consolidated and streamlined 11 departmental change control programs into 3. Redesign the main change control program to meet client and regulatory requirements. Conducted training and mentored users of the change control system. Reported to the Director of Quality Assurance
CD Lead, Quality Systems (Consultant), GENZYME, Cambridge, MA (2011 – 2013)
Primary contact and responsible person for representing the client’s quality organization in the development and implementation of assigned quality system elements and other consent decree activities. Areas of responsibility include: Documents, Records Control and Retention; Document Architecture, Format, and Content; Facilities and Equipment Document Control; Change Control; Labeling Development and Labeling Changes; Quality Systems Standards Management.
- Report to the Director, Quality Systems and the site Consent Decree Lead, Quality. Work closely with the site subject matter experts and the Global Consent Decree teams to build compliant quality systems for areas of responsibility and ensure that the deliverables and milestones are delivered on time.
- Represent client quality organization on cross-functional teams in design and implementation of new or updated quality systems in accordance with the consent decree work plan, corporate standards, cGMP, and industry standards. Interface with Operations, Quality Management and Development to assure all products and processes are in accordance with company standards and quality system.
- Monitor quality system activities to assure compliance with company and regulatory standards.
- Develop appropriate metrics and track effectiveness and productivity of the quality system.
- Direct departmental resources to ensure timely and compliant implementation of the Consent Decree Work Plan. Develop qualified and capable talent through training and mentoring to assure appropriate resources are available for current and future requirements.
CELGENE CORPORATION, Summit, NJ (2007 – 2011)
Sr. Manager, QA Global Change Control
- Ownership of the QA Change Control System included oversight of the change control process impacting Celgene products and GMP activities at vendors, contractors, service providers and Celgene sites.
- Developed, implemented and maintained the activities of the change control processes in compliance with cGMPs, SOPs, good documentation practices and in accordance with corporate, regulatory and compliance expectations.
- System quality oversight included leadership, management, status reporting and performance metric monitoring, providing decisions on product and GMP impact of change; risk assessment to analyze the impact of change, analyze change feedback, and collect customer requirements for future changes, approval of change requests, implementation plans, close out reports and monitoring post closeout commitments.
- Assisted in the collection and periodic evaluation of vendor changes impacting Celgene products and DMFs. Communicated information, metrics and product impact assessments to senior management as required by site procedures or as requested. Communicated and coordinated with staff, internal customers and external vendors, contractors and service providers to provide timely services.
WATSON PHARMACEUTICALS, INC., Salt Lake City, UT (2003 – 2007)
Manager, Pharmaceutical Technology
- Ensured GMP compliance related to validation activities for process scale-up, clinical supplies, commercial operations and oversight of project timelines. Responsible for the manufacture of pilot and exhibit batches to be used for clinical and stability studies, NDA and ANDA applications. Reviewed validation strategies and identify compliance gaps in the following areas to be consistent with corporate policies, SOPs and regulatory guidelines in order to effect/facilitate submission approvals: Technology Transfer, Process Validation, Cleaning Validation, Clinical Supplies, Computer Validation, Equipment and Facility Qualification.
- Planned and managed the activities of the Pharmaceutical Technology Department and provided direction and support to production facilities for the validation of processes in the manufacture of commercial products and evaluation of product lifecycles.
- Established and implemented validation philosophies, GMP/environmental control standards and process equipment/facility maintenance support programs to ensure a compliant regulatory program.
- Experienced in system and facility, utility, laboratory and manufacturing equipment, process control system qualification and validation. Responsible for the review and approval of validation protocols, reports, policies and SOPs to ensure Regulatory and cGMP compliance. Experience on the validation of process control systems, DCS and PLC, computer systems related to analytical instrumentation, Part 11 requirements, and mainframe systems.
- Provided data and information required for DMF and ANDA submissions including post-submission changes. Participated in developing filing strategies, developing project management tools, review of DMFs and ANDAs as part of multidisciplinary team.
BAXTER, (FORMERLY WYETH-AYERST), Cherry Hill, NJ (1999 – 2004)
Manager, QA, Change Control
- Provided leadership and direction on global GMP documentation systems, processes, change control and associated quality programs to minimize product quality compliance issues.
- Ensured that change control, documentation systems and processes are effective, efficient and harmonized in meeting regulatory requirements, commitments and industry trends which include Equipment, Facilities, Processes and Systems, Monographs, Test Methods and Specifications.
- Designated as liaison between functional departments, outside vendors, collaborators and corporate concerning change controls and documentation for validated equipment, facilities, product transfers, processes and computer and electronic data systems.
- Communicated process, quality system and program issues to senior management. Effective in communication, facilitation, problem solving, presentation and negotiating skills. Chair the inter-departmental Change Control Committee chartered to review proposed changes and its impact to product quality.
- Assisted in the resolution of internal and external cGMP audits, Regulatory agency inspections, manufacturing investigations, deviations and product complaints.
- Represented the Quality Assurance Department in new product teams to support product validation and process optimization, FDA submissions and commercial manufacturing including third party contracts.
MARSAM PHARMACEUTICALS, Cherry Hill, NJ (1997 – 1999)
Senior Validation Engineer, Validation Department
- Provided leadership and management experience to assure appropriate, effective, and optimum activities within the Validation program and related projects, day to day activities and schedules involving equipment, facilities, utilities, computer, process, and cleaning validation.
- Developed validation protocols (IQ, OQ, PQ, Cleaning, Sterilization) and generated technical reports detailing all test results and conclusions after collection and analysis of data. Assisted in troubleshooting of production problems where required. Coordinated various departments in completing validation trials based on written protocols.
MOLECULAR BIOSYSTEMS, INC., San Diego, CA (1996 – 1997)
Senior Validation Engineer, QA Department
- Responsible for the management, development, evaluation and implementation of the validation program to assure that the manufacturing process is in accordance with appropriate regulatory, compendia, company policies and current Good Manufacturing Practices.
- Oversaw and reviewed validation activities, documents and data generated. Evaluated and implemented changes or improvements to processes or equipment based on statistical analysis and sound scientific observation.
- Served as an information resource for the multi-disciplinary/department validation group. Development and implementation of Master Validation Plans and departmental budget planning.
ESI-LEDERLE (A DIVISION OF WYETH-AYERST), Cherry Hill, NJ (1983 – 1996)
Validation Scientist, Validation Department (1991 – 1996)
- Responsible for assuring appropriate, effective and optimum activities within the Validation program and related projects. Developed validation protocols (IQ, OQ, PQ, Cleaning, Sterilization) for new/existing equipment, processes and systems.
- Assisted in the change control program. Participated in new equipment checkout and factory acceptance test.
- Team member for the acceptance and transition phase of new integrated Water for Injection and sterilization system from validation contractors and vendors.
Liaison Scientist/Microbiologist R&D (1987 – 1991)
- Developed and validated microbiological assay methods and SOP's for product development program.
- Responsible for chemical, microbiological and particulate matter testing of finished products and raw materials in the Penicillin/Cephalosporin laboratory utilizing USP/CFR methods.
Senior Technician, Analytical Development (1983 – 1987)
- Responsible for the analytical testing of products for the commercial and development stability program by HPLC, GC, AA, TLC and other established methods. Analytical testing of products, raw materials and preservatives for various products.
- Prepared laboratory reagents and solutions. Performed physical testing, validation and documentation of in-process rubber stoppers, line seals, closures, plungers, hubs and syringe components.
B.S., ZOOLOGY, Far Eastern University, Manila, Philippines
BASIC COLLEGE CURRICULUM, University of Santo Tomas, Manila, Philippines