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:
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.
Qualifications:
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.
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.
This is a critical role within our organization, offering the opportunity to ensure the quality and compliance of our pharmaceutical products and processes. Competitive compensation packages are available.
EEO Employer:
Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact [email protected].
Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality.
Skills Required
- Bachelor's degree in pharmacy, chemistry, biology, engineering, or related field
- Minimum of 5 years of experience in GMP compliance
- Deep understanding of GMP regulations and guidelines
- Experience with GMP quality systems
- Strong analytical and problem-solving skills
- Excellent communication and interpersonal skills
- Auditing experience and knowledge of audit principles and practices
- Regulatory affairs certification or relevant professional certification
What We Do
Pharmavise is a regulatory compliance consulting firm specializing in the life sciences industry, providing solutions throughout the product lifecycle for pharmaceutical, medical device, and biotechnology clients.
