Job Overview: We are seeking a highly experienced and qualified individual to fill the position of Contract Experienced Qualified Person (QP) in our pharmaceutical organisation. The successful candidate will play a pivotal role in ensuring compliance with regulatory standards and maintaining the highest levels of quality in their pharmaceutical manufacturing processes. This is a contractual position, and the individual will be responsible for overseeing key aspects of the quality assurance and regulatory compliance functions.

Responsibilities:

QP Oversight:

Assume the role of Qualified Person (QP) as defined by regulatory authorities, ensuring that all medicinal products released for sale meet the required quality standards. Regulatory Compliance:

Maintain an up-to-date knowledge of relevant pharmaceutical regulations, guidelines, and industry best practices to ensure continuous compliance with Good Manufacturing Practice (GMP) and other applicable regulatory requirements. Batch Release:

Review and approve batch documentation, ensuring that each batch of pharmaceutical products complies with established quality specifications and is in accordance with regulatory requirements. Quality Management Systems (QMS):

Contribute to the development, implementation, and maintenance of the Quality Management System, including procedures, processes, and documentation. Supplier and Vendor Management:

Collaborate with relevant departments to ensure the effective management of suppliers and vendors, conducting audits and assessments as necessary to maintain the highest standards of quality. Deviation and CAPA Management:

Oversee the investigation of deviations, non-conformances, and customer complaints, leading the development and implementation of effective Corrective and Preventive Actions (CAPAs). Change Control:

Manage and assess changes to manufacturing processes, facilities, and systems to ensure that they do not adversely affect product quality, and that changes are implemented in compliance with regulatory requirements. Training and Development:

Provide guidance and support in the training and development of personnel involved in pharmaceutical manufacturing, ensuring a high level of competence and awareness of quality standards. Risk Management:

Conduct risk assessments related to product quality and regulatory compliance, implementing risk mitigation strategies and ensuring continuous improvement. Documentation Management:

Oversee the creation, review, and approval of critical quality documentation, including batch records, standard operating procedures (SOPs), and quality agreements. Qualifications:

Qualified Person (QP) status as per regulatory requirements. Extensive experience in pharmaceutical quality assurance and regulatory compliance. Strong knowledge of GMP, GDP, and other relevant regulatory standards. Excellent communication and interpersonal skills. Proven ability to work in a cross-functional team environment. Analytical mindset and attention to detail.