Manuel Pol work email
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Manuel Pol personal email
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Quality Assurance Management Professional with extensive experience in the fast paced, deadline oriented, quality focused manufacturing and research and development environments. Skilled at developing and enhancing Quality Systems, such as internal and external Auditing, Change Management, Document Control, Investigations, and Laboratory Controls. Reputation as self-motivated; results driven professional who performs well individually or as part of a team. Fully bilingual, English and Spanish. Key strengths include:• Expert in GMP Regulations (21CRF210-211)• Change Control System assessment for improvement.• Training System Enhancement• R&D Quality Assurance Expertise. • On the Job Training Developer, Certified Train the Trainer and Curriculum Designer• Documentation Control system development or redesigning.• CAPA (Corrective Action / Preventive Action) expert.
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Senior ConsultantOptigroup Llc Jan 2018 - Present
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Senior ConsultantAlku Dec 2016 - PresentAndover, Ma, UsProvided Product Impact assessment of documentation for FDA's cGMP and GDP compliance. In a Bio Pharmaceutical manufacturer of Plasma derived products. -
Compliance ConsultantRegulatory Compliance Associates Inc. Nov 2015 - PresentPleasant Prairie, Wi, UsProvide compliance consulting services to a Parenteral manufacturing plant -
Senior ConsultantValidant Apr 2013 - PresentSan Francisco, Ca, Us• Served as Project Manager- providing project oversight, establishing project planning, progress metrics, and providing weekly status report to management.• Closed seven (7) assigned audit observations on time; these observations were related to curriculum content and assignment processes gaps.• Revised the On the Job Training procedure, assisted in revising the General Training procedure and co-created the training Curriculum Development & Revision management procedure as response to audit observations. • Developed and facilitated On the Job Training course sessions, achieving 100% target audience participants; in addition, created a knowledge transfer assessment’s training effectiveness statistical report study. -
Qa Consultant - Document CertifierRca 2015 - 2016
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Senior Manufacturing/Quality Support SpecialistNoven Pharmaceuticals Oct 2009 - Nov 2013Miami, Florida, UsProvided support and mentoring to Quality Management responsible for Quality Systems , focusing in streamlining, updating and improving the cGMP compliance level in the GMP Training corporate wide. Provide mentoring to the QA Supervisory staff as required. -
Quality Assurance ManagerWatson Pharmaceuticals Apr 2006 - May 2009Dublin, IeManaged the Quality Assurance Department in a Research and Development operation, in the development of solid dose formulations. -
Senior Quality ConsultantSchering-Plough 2003 - 2006QA consulting in the areas of documentation, training and FDA commitments compliance review. In a Consent Decree regulatory environment site.
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Senior Quality ConsultantWyeth Pharmaceuticals 2001 - 2003New York, New York, UsProvided Process Validation consulting services, subcontracted thru Tunnel Consulting, Inc. -
Qa Compliance And Training ManagerMonsanto 2000 - 2001St. Louis, Missouri, UsProvided internal and external auditing to the veterinary parenteral manufacturing plant. In addition in charged of the GMP training program plant wide. -
Qa Manager And Gmp Training ManagerIvax Pharmaceuticals 1993 - 2001Tel-Aviv, IlQA Manager - Responsible to manage the QA Department, this include the supervision of 14 QA Inspectors and the product disposition group. -
Associate Research ScientistBaxter Healthcare 1987 - 1993Deerfield, Illinois, UsProvided research scientific services to the R&D group in a Biotechnology operation -
Qa System AnalystMerc, Sharp & Dohme 1983 - Jun 1987
Manuel Pol Skills
Manuel Pol Education Details
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Pontificia Universidad Católica De Puerto RicoChemistry -
Skillpath CorporationTrain The Trainer Master Certification
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University Of PhoenixMaster In Business Administration
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University Of PhoenixGeneral
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University Of PhoenixGeneral
Frequently Asked Questions about Manuel Pol
What company does Manuel Pol work for?
Manuel Pol works for Alku
What is Manuel Pol's role at the current company?
Manuel Pol's current role is Senior Consultant at OptiGroup LLC.
What is Manuel Pol's email address?
Manuel Pol's email address is po****@****ail.com
What schools did Manuel Pol attend?
Manuel Pol attended Pontificia Universidad Católica De Puerto Rico, Skillpath Corporation, University Of Phoenix, University Of Phoenix, University Of Phoenix.
What are some of Manuel Pol's interests?
Manuel Pol has interest in Children, Economic Empowerment, Environment, Education, Science And Technology, Animal Welfare, Arts And Culture.
What skills is Manuel Pol known for?
Manuel Pol has skills like Fda, Gmp, Quality Assurance, Capa, Pharmaceutical Industry, Change Control, Quality System, V&v, 21 Cfr Part 11, Validation, Biotechnology, Sop.
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