QP

Qualified Person (QP)

We are seeking an experienced and highly skilled Qualified Person (QP) to join our pharmaceutical company. The successful candidate will play a crucial role in ensuring the quality, safety, and regulatory compliance of our medicinal products.

Responsibilities:

Quality Assurance and Compliance

• Oversee quality assurance processes to ensure compliance with Good Manufacturing Practice (GMP) regulations
• Review and approve batch documentation, including records, analytical data, and manufacturing protocols
• Ensure adherence to company standards and regulatory requirements throughout the manufacturing process

Batch Release

• Conduct thorough reviews of all relevant documentation before certifying batches for release
• Make final decisions on batch release, considering quality, safety, and regulatory compliance

Regulatory Affairs

• Stay updated on regulatory changes and interpret guidelines for the organization
• Provide guidance on implementing new regulatory requirements
• Participate in regulatory inspections and audits, collaborating with cross-functional teams

Quality Management

• Contribute to the development and maintenance of the company's quality management systems
• Review and approve quality-related documents such as SOPs, change controls, and deviation investigations

Risk Assessment

• Identify and assess potential quality risks in manufacturing and distribution processes
• Develop and implement risk mitigation strategies to ensure product quality and patient safety

Training and Development

• Provide training on GMP principles, quality procedures, and regulatory requirements
• Foster a culture of continuous improvement within the quality team

Qualifications:

• Degree in Pharmacy, Chemistry, Biology, or a related field
• Membership in a relevant professional body (e.g., Royal Society of Chemistry, Royal Pharmaceutical Society)
• Minimum of 5 years experience in pharmaceutical quality assurance or related roles
• In-depth knowledge of GMP regulations and pharmaceutical manufacturing processes
• Strong analytical and problem-solving skills
• Excellent communication and leadership abilities

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.