Lourdes Amelia Molina Rincón
Regulatory Affairs and Compliance Senior Consultant at Pharma CLIM Services S.A de C.V- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
-
Español Native or bilingual proficiency
-
Ingles Full professional proficiency
-
Italiano Professional working proficiency
Topline Score
Bio
Karelia Montalvo
excelente servicio y atención
Alberto Coutiño
El trabajo de Lourdes se caracteriza por su profesionalismo y entrega para lograr los objetivos fijados, la capacidad para formar equipos de trabajo, realizar la gestión de recursos y colaborar en los diferentes proyectos estratégicos de la organización, compartir su amplia experiencia son características que resaltan de la personalidad de Lourdes. Es para mi un gusto poder recomendar ampliamente por este medio las cualidades personales y profesionales de Lourdes.
Eliseba Vargas
Time and projects I had the oportunity to work with Lourdes were always strongly focussed on results, her hability to see situations on different scenarios allowed her and her team to reach goals and overcome several situations acomplishing always comitments. Looking always for their improvemente and selfdevelopment, Lourdes always did all the necesary in ordert to develop each member of her team and was really involved in any process concerning her area and team. I could say that her department at that moment alwas showed a team work and focussed oriented work.
Karelia Montalvo
excelente servicio y atención
Alberto Coutiño
El trabajo de Lourdes se caracteriza por su profesionalismo y entrega para lograr los objetivos fijados, la capacidad para formar equipos de trabajo, realizar la gestión de recursos y colaborar en los diferentes proyectos estratégicos de la organización, compartir su amplia experiencia son características que resaltan de la personalidad de Lourdes. Es para mi un gusto poder recomendar ampliamente por este medio las cualidades personales y profesionales de Lourdes.
Eliseba Vargas
Time and projects I had the oportunity to work with Lourdes were always strongly focussed on results, her hability to see situations on different scenarios allowed her and her team to reach goals and overcome several situations acomplishing always comitments. Looking always for their improvemente and selfdevelopment, Lourdes always did all the necesary in ordert to develop each member of her team and was really involved in any process concerning her area and team. I could say that her department at that moment alwas showed a team work and focussed oriented work.
Karelia Montalvo
excelente servicio y atención
Alberto Coutiño
El trabajo de Lourdes se caracteriza por su profesionalismo y entrega para lograr los objetivos fijados, la capacidad para formar equipos de trabajo, realizar la gestión de recursos y colaborar en los diferentes proyectos estratégicos de la organización, compartir su amplia experiencia son características que resaltan de la personalidad de Lourdes. Es para mi un gusto poder recomendar ampliamente por este medio las cualidades personales y profesionales de Lourdes.
Eliseba Vargas
Time and projects I had the oportunity to work with Lourdes were always strongly focussed on results, her hability to see situations on different scenarios allowed her and her team to reach goals and overcome several situations acomplishing always comitments. Looking always for their improvemente and selfdevelopment, Lourdes always did all the necesary in ordert to develop each member of her team and was really involved in any process concerning her area and team. I could say that her department at that moment alwas showed a team work and focussed oriented work.
Karelia Montalvo
excelente servicio y atención
Alberto Coutiño
El trabajo de Lourdes se caracteriza por su profesionalismo y entrega para lograr los objetivos fijados, la capacidad para formar equipos de trabajo, realizar la gestión de recursos y colaborar en los diferentes proyectos estratégicos de la organización, compartir su amplia experiencia son características que resaltan de la personalidad de Lourdes. Es para mi un gusto poder recomendar ampliamente por este medio las cualidades personales y profesionales de Lourdes.
Eliseba Vargas
Time and projects I had the oportunity to work with Lourdes were always strongly focussed on results, her hability to see situations on different scenarios allowed her and her team to reach goals and overcome several situations acomplishing always comitments. Looking always for their improvemente and selfdevelopment, Lourdes always did all the necesary in ordert to develop each member of her team and was really involved in any process concerning her area and team. I could say that her department at that moment alwas showed a team work and focussed oriented work.
Credentials
-
Certified Trainer
Secretaría de trabajo y previsión socialMay, 2018- Nov, 2024 -
PCQI (Preventive Control Qualified Individual)
Illinois Tech, Institute for Food Safety and Health (IFSH)Nov, 2017- Nov, 2024 -
Certified Quality Auditor
ASQ - World HeadquartersOct, 2004- Nov, 2024 -
Expert in Commission of Generalities of Mexican Farmacopeia
Farmacopea de los Estados Unidos MexicanosOct, 2019- Nov, 2024
Experience
-
Pharma CLIM Services S.A de C.V
-
Mexico
-
Pharmaceutical Manufacturing
-
1 - 100 Employee
-
Regulatory Affairs and Compliance Senior Consultant
-
Oct 2015 - Present
Senior Consultant with almost 30 years of experience in Pharmaceutica Industry at North America and LATAM. Proficient in Regulatory Affairs, Quality Operations, Regulatory and Technical Document Management, Data Integrity, Risk Management, Validation, CSV,Project Management, Training. Consulting goals achieving through integration of high-performance teams guided by a strategic plan and the best regulatory practices. Senior Consultant with almost 30 years of experience in Pharmaceutica Industry at North America and LATAM. Proficient in Regulatory Affairs, Quality Operations, Regulatory and Technical Document Management, Data Integrity, Risk Management, Validation, CSV,Project Management, Training. Consulting goals achieving through integration of high-performance teams guided by a strategic plan and the best regulatory practices.
-
-
-
Pfizer
-
Toluca
-
Site Compliance Manager
-
Jun 2021 - May 2022
• Manage the processes to ensure that the plant remains in regulatory compliance by maintaining the CBPF in force for local and export markets. • Maintenance of technical documentation to maintain the regulatory compliance of the CMC (Chemistry, Manufacturing & Control) of each product marketed by Pfizer locally and in LATAM. • Self-inspections and supplier management. • Readiness Inspection Program • Management of biological drugs (vaccines) and controlled substances. • Manage the processes to ensure that the plant remains in regulatory compliance by maintaining the CBPF in force for local and export markets. • Maintenance of technical documentation to maintain the regulatory compliance of the CMC (Chemistry, Manufacturing & Control) of each product marketed by Pfizer locally and in LATAM. • Self-inspections and supplier management. • Readiness Inspection Program • Management of biological drugs (vaccines) and controlled substances.
-
-
-
Amepres México
-
Mexico
-
Business Consulting and Services
-
1 - 100 Employee
-
Board member and Champion of Commission of quality
-
2014 - May 2022
Volunteer staff Participate in the organization of activities to achieve the improvement of local regulatory practices and mexican legislation applicable to life science products. We are a professional organization that gather the experience and improvement ideas of regulatory affairs proffesionals to make proposals and work together with COFEPRIS in the implementation of regulative initiatives. Volunteer staff Participate in the organization of activities to achieve the improvement of local regulatory practices and mexican legislation applicable to life science products. We are a professional organization that gather the experience and improvement ideas of regulatory affairs proffesionals to make proposals and work together with COFEPRIS in the implementation of regulative initiatives.
-
-
-
Lundbeck
-
Denmark
-
Pharmaceutical Manufacturing
-
700 & Above Employee
-
Quality Manager and Qualified Person
-
Feb 2011 - Mar 2013
Responsible for Quality Operations attained to GMP compliance to assure the timely supply of product to the martket with a high service level. On the other hand, associate decision maker for quality and regulatory affair matters with the top management level. Achievements: • Achieved in 12 months the COFEPRIS license authorization to market controlled medicines through a distribution warehouse without any impact in the business daily operation. • 30% of productivity increase in daily operations of materials and product release through process optimization with Lean tools and Balance Score Card (BSC). • Due to the plant shutdown, the quality organization was re-structured efficiently and successfully with a sustainable budget reduction of 40%. • My first glare in Lundbeck was that quality control process was not in compliance with GMPs. It was sanitized in 12 months. Show less
-
-
-
Armstrong Laboratorios de México S.A. de C.V.
-
Mexico
-
Pharmaceutical Manufacturing
-
400 - 500 Employee
-
Quality Manager
-
May 2008 - Jan 2011
Responsible for daily quality operations attained to GMP compliance, to assure the timely supply of product to the martket with a high service level. On the other hand, associate decision maker for quality matters with the top management level. Achievements: • 35% of Service Level increase to planning department through Lean and Capacity definition tools as well as a BSC. • Sustained 15% in personnel reduction and $875.000.00 MXN reduction in budgeted over-time payments through management of quality operations taking base in processes and a BSC. • Sustained 20% reduction in a $26,000,000.00 MXN budget in 2.5 years through management of defined processes, integration of contracted services and re-negotiation of service contracts. Show less
-
-
-
Merck Group
-
Germany
-
Pharmaceutical Manufacturing
-
700 & Above Employee
-
Quality Control Manager
-
Feb 2006 - Dec 2007
Responsible for daily quality control operations attained to GMP compliance to assure the timely inspection and analysisi of materials and products with a high service level. On the other hand, associate decision maker for quality control matters with the Qualified Person and Operations Managers. Achievements: • Savings of $1, 500,000.00 MXN through integration of several contracted analysis to the analytical program for 10 biotech products. • Sustained 20% budget reduction through renegotiation of analysis contracts and a reduction of analysis under a GMP justification. • Given a lack of a quality system, I have implemented it for Serono in one year. • 30% of productivity increase and 40% of cost reduction per Supply Chain Cycle through the implementation of the simplified release program for biotech products. Shared achievement with Regulatory Affairs. • From 84 to 98% of supply chain service level increase for an endocrinological product through pursuing the product specification modification in FEUM (Mexican Pharmacopeia). Show less
-
-
-
Pfizer
-
United States
-
Pharmaceutical Manufacturing
-
700 & Above Employee
-
Quality Systems Manager
-
Apr 2002 - Dec 2005
Responsible for quality system operation and management to assure GMP compliance of manufactured products and product/process/system continuoous improvement. On the other hand, associate decision maker for quality matters with the Quality Director. Achievements: • Achieved a successful HPB (Health Protection Branch) and FDA (Food and Drug Administration) re-certification of high volume parentherals manufacturing line. • Achieved in 1.5 years the implementation of Pfizer GMP Corporate Guidelines. • Integrated a network of internal auditors and trainers to support related programs in two manufacturing plants. Show less
-
-
-
Boehringer Ingelheim
-
Germany
-
Pharmaceutical Manufacturing
-
700 & Above Employee
-
Head of Quality Audits
-
May 1997 - Apr 2002
Operate GMP training, auditing and vendors validation programs. Besides projects coordination and associate decision maker with the Quality Manager. Achievements: • Implemented and validated the first automated warehouse in Mexico with a 30% of productivity increase and a personnel reduction of 50%. • Sustained savings of $2, 000,000.00 MXN because of reduction of scrapped inventories with short shelf life, taking advantage of BPCS functionality. Operate GMP training, auditing and vendors validation programs. Besides projects coordination and associate decision maker with the Quality Manager. Achievements: • Implemented and validated the first automated warehouse in Mexico with a 30% of productivity increase and a personnel reduction of 50%. • Sustained savings of $2, 000,000.00 MXN because of reduction of scrapped inventories with short shelf life, taking advantage of BPCS functionality.
-
-
Education
-
1989 - 1994
Universidad Nacional Autónoma de México
Bachelor's degree, Medicinal and Pharmaceutical Chemistry -
2014 - 2014
Universidad Iberoamericana, Ciudad de México
Diploma, Black Belt in Six Sigma Methodology -
2000 - 2000
ITAM
Diploma, Total Quality and Process Improvement
Community
