Contract Qualified Person

Position Overview:
As a Contract Qualified Person, you will play a crucial role in maintaining the highest standards of product quality and regulatory compliance. You will be responsible for certifying batches for release to market, ensuring that all products meet the stringent requirements of regulatory authorities. This is a contract position with the potential for further extension, offering you the opportunity to work with a diverse and talented team in a challenging and rewarding environment.
Key Responsibilities:
Certify batches for release, ensuring compliance with regulatory requirements and company standards. Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Manufacturing, to ensure seamless product release processes. Conduct risk assessments and provide expert guidance on quality and compliance issues. Review and approve manufacturing and testing documentation, including batch records and analytical data. Stay current with industry regulations and best practices to ensure the company's continued compliance and success.
Qualifications:
Qualified Person status in accordance with relevant regulatory requirements. Solid experience in the pharmaceutical and medical device industry. Thorough understanding of Good Manufacturing Practice (GMP) and regulatory guidelines. Strong analytical and problem-solving skills, with meticulous attention to detail. Excellent communication and interpersonal skills to effectively collaborate with diverse teams. Ability to work independently and make critical decisions under pressure.
Education and Experience:
Qualified Person certification in accordance with regulatory standards. Minimum of 5 years of experience in a similar role within the pharmaceutical or medical device industry.