Tina Grybus Email & Phone Number | Professional with over 15 years of practical experience and a solid understanding of a regulated industry. Experience with Good Manufacturing Practices, Corrective Action Preventive Action (CAPA), manufacturing equipment, utilities, and automation. Primary contact for regulatory (FDA, Japan FDA, Korean FDA, EMEA), internal, customer and third party audits. Functioned as onsite QA support at Stryker for the Corporate RAQA group. Developed working knowledge of Medical Device Regulations and Medical Device FDA databases. As an onsite consultant at Grand River, managed a team of up to three validation engineers at a new aseptic manufacturing facility • Functioned as the site coordinator for all validation activities • Responsible for validation schedule, documentation review, test equipment coordination, customer interface between contactors, and subcontractor activities/turnover packages • Lead equipment installation and process trouble shooting. As a Quality Professional, developed a new quality support system to support Active Pharmacuetical Ingredient production, supported and improved program when it was implemented, and became a site and global expert on the system. I had numerous creation, review, and approval responsibilities and recieved several site recognitions and awards. Specialties: Pharmaceutical utilities (high purity water, compressed gas), production equipment, quality assurance, equipment and utility validation, and internal auditing

Tina Grybus

Professional with over 15 years of practical experience and a solid understanding of a regulated ind...
Gobles, Michigan, United States

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Tina Grybus’s Location Gobles, Michigan, United States

Tina Grybus’s Current Industry Perrigo

Tina Grybus’s Prior Industry Crb Consulting Engineers | Propharma | Pfizer | Prima Communications

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Production Engineer

2012-01-01 00:00:00 - Present

Project Engineer

2011-01-01 00:00:00 - 2012-01-01 00:00:00

Independent Quality Consultant

2010-09-01 00:00:00 - 2011-03-01 00:00:00

Quality Assurance Professional

2000-09-01 00:00:00 - 2009-06-01 00:00:00

Contractor

1995-03-01 00:00:00 - 2000-09-01 00:00:00

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Tina Grybus is a Professional with over 15 years of practical experience and a solid understanding of a regulated industry. Experience with Good Manufacturing Practices, Corrective Action Preventive Action (CAPA), manufacturing equipment, utilities, and automation. Primary contact for regulatory (FDA, Japan FDA, Korean FDA, EMEA), internal, customer and third party audits. Functioned as onsite QA support at Stryker for the Corporate RAQA group. Developed working knowledge of Medical Device Regulations and Medical Device FDA databases. As an onsite consultant at Grand River, managed a team of up to three validation engineers at a new aseptic manufacturing facility • Functioned as the site coordinator for all validation activities • Responsible for validation schedule, documentation review, test equipment coordination, customer interface between contactors, and subcontractor activities/turnover packages • Lead equipment installation and process trouble shooting. As a Quality Professional, developed a new quality support system to support Active Pharmacuetical Ingredient production, supported and improved program when it was implemented, and became a site and global expert on the system. I had numerous creation, review, and approval responsibilities and recieved several site recognitions and awards. Specialties: Pharmaceutical utilities (high purity water, compressed gas), production equipment, quality assurance, equipment and utility validation, and internal auditing