GMP Professionals

Pharmavise Corporation•Maple Grove, MN

About The Position

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com We are currently seeking dedicated and experienced professionals to join our team as GMP (Good Manufacturing Practice) Professionals. Below is a comprehensive job description outlining the responsibilities, qualifications, and expectations for this role:

Requirements

Bachelor's degree in pharmacy, chemistry, biology, engineering, or related field; advanced degree preferred.
Minimum of 5 years of experience in GMP compliance within the pharmaceutical, biotechnology, or medical device industry.
Deep understanding of GMP regulations and guidelines applicable to pharmaceutical manufacturing, packaging, and distribution activities.
Experience with GMP quality systems, including document management, change control, deviations, and CAPA.
Strong analytical and problem-solving skills, with the ability to interpret and apply complex regulatory requirements.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.

Nice To Haves

Auditing experience and knowledge of audit principles and practices preferred.
Regulatory affairs certification (RAC) or relevant professional certification (e.g., ASQ Certified Quality Auditor) preferred but not required.

Responsibilities

Ensure compliance with GMP regulations, standards, and guidelines in all aspects of pharmaceutical manufacturing, packaging, and distribution processes.
Review and interpret GMP requirements from regulatory agencies (e.g., FDA, EMA) and industry standards (e.g., ICH Q7, EU GMP) to ensure alignment with company policies and procedures.
Develop, implement, and maintain GMP quality systems, including documentation control, change control, deviation management, and CAPA (Corrective and Preventive Actions).
Conduct internal GMP audits and inspections to assess compliance with GMP regulations and identify areas for improvement.
Collaborate with cross-functional teams, including manufacturing, quality assurance, quality control, regulatory affairs, and supply chain, to address GMP-related issues and drive continuous improvement initiatives.
Provide GMP training and guidance to personnel involved in manufacturing and quality operations to ensure awareness and understanding of GMP requirements.
Participate in regulatory inspections and audits conducted by health authorities and provide support in addressing findings and implementing corrective actions.
Stay abreast of changes and updates to GMP regulations, industry best practices, and technological advancements in pharmaceutical manufacturing.