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We are currently seeking an ambitious, dynamic and driven Quality Manager with extensive pharmaceutical experience to join a rapidly growing generics business based in Hertfordshire. About the business and the role: Our client are a small pharmaceutical business, with a growing portfolio of generic products, supplying into the UK market. The Quality Manager role is a key hire for the business as they look to establish an internal quality function that will be core to the business moving forward. The Quality Manager will be responsible for all aspects of Quality within the business - from the set-up of the QMS through to interfacing with external stakeholders including CMO's and the regulatory bodies (MHRA), the role will expose you to all parts of quality management within the business. In the initial phase, the Quality Manager will be a standalone role, so you need to be prepared to roll your sleeves up and get your hands dirty, with the longer term plan of building the quality team/function around you. The key responsibilities for the Quality Manager role will involve the following: Managing Corrective and Preventive Actions (CAPA): Initiating, coordinating, and overseeing CAPA processes to address quality issues, ensure compliance, and drive continuous improvement. Handling Deviations: Investigating and managing deviations from established procedures, assessing their impact on product quality, and implementing corrective actions to maintain compliance and product integrity. Leading Change Control Processes: Facilitating the evaluation, approval, and implementation of changes to processes, procedures, and systems while ensuring compliance with regulatory requirements and quality standards. Implementing and Maintaining Quality Management Systems (QMS): Establishing, maintaining, and improving QMS to meet regulatory standards, enhance product quality, and drive efficiency across all operations. Temperature Management throughout the Supply Chain: Developing and implementing protocols and procedures for monitoring and managing temperature conditions during storage, transportation, and distribution of pharmaceutical products to ensure compliance with GMP and GDP. Supporting QP/RPi batch release: Assisting with batch release activities, including documentation review, batch disposition, and ensuring compliance with regulatory requirements. Developing and Maintaining Standard Operating Procedures (SOPs): Creating, revising, and updating SOPs to ensure consistency, compliance, and efficiency in all quality-related processes and activities. Vendor/Supplier Qualification, Verification, and Management: Establishing and maintaining robust processes for vendor and supplier qualification, auditing, and performance monitoring to ensure the quality and reliability of raw materials and services. Providing General Quality Assurance (QA) Support: Offering expertise and guidance on quality-related matters, conducting internal audits, providing training, and facilitating continuous improvement initiatives to promote a culture of quality throughout the organization. Ensuring Compliance with GMP and GDP: Monitoring, assessing, and ensuring compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) to uphold product quality, safety, and regulatory requirements. The ideal candidate for the Quality Manager role will have the following background: Demonstrable Quality experience within the Pharmaceutical industry, with a strong understanding of GMP and GDP guidelines. The ability and appetite to work in a standalone Quality Manager role and be responsible for all aspects of quality within the business. Excellent communication, interpersonal, and organisational skills Ability to work independently and collaboratively with cross-functional teams Keywords: Quality Manager, Quality Lead, QA Manager, Quality Assurance Manager, Head of Quality
Job Title: Quality Manager Company Overview: Central Employment is proud to partner with a leading SME plastic injection molding business dedicated to delivering high-quality products to clients. Our client is committed to innovation and excellence, striving to meet and exceed industry standards while fostering a culture of continuous improvement and customer satisfaction. Position Overview: We are seeking a highly skilled Quality Manager to join our client's team. The Quality Manager will play a crucial role in ensuring that manufacturing processes consistently produce products of the highest quality. This position is pivotal in maintaining our client's reputation for excellence in the industry. Key Responsibilities: Regulatory Compliance: To guarantee product quality and compliance, ensure strict adherence to regulatory standards such as ISO 9001, IATF, and internal auditing requirements. Quality Management System (QMS): Develop, implement, and maintain a robust QMS that aligns with industry standards and regulatory requirements, facilitating effective quality control and continuous improvement processes. Communication: Act as a primary point of contact for quality-related inquiries and issues, fostering clear and efficient communication channels between internal teams and external bodies to address quality concerns promptly. Laboratory Management: Oversee the maintenance and review of laboratory scope to accurately reflect organizational capabilities and ensure compliance with quality standards, facilitating reliable testing and analysis processes. APQP Coordination: Assist in coordinating Advanced Product Quality Planning (APQP) activities, including documentation, reviews, and implementation of quality planning processes, to ensure product quality and customer satisfaction throughout the product lifecycle. Process Optimization: Use expertise in developing process flow diagrams to visualize and optimize manufacturing processes, identify inefficiencies, and implement improvements to enhance productivity and quality outcomes. Part Approval Planning: Manage and compile part approval planning processes, including gathering necessary documentation, conducting reviews, and obtaining approvals from stakeholders, to ensure product conformance and customer satisfaction. Capability Studies: Support in conducting process and machine capability studies, analyzing data, and implementing corrective actions to improve process capabilities and enhance product quality and consistency. Analytical Skills: Demonstrate strong analytical abilities for data interpretation and process improvement, utilizing statistical tools and methods to identify trends, anomalies, and opportunities for optimization. Project Management: Apply effective organizational skills to manage quality-related projects, ensuring timely completion, resource allocation, and alignment with organizational goals and objectives. Requirements: Education: Bachelor's degree in Engineering, Quality Management, or related field. Experience: Minimum of 5 years of experience in quality management roles within the manufacturing industry, preferably in plastic injection molding. Skills: Strong understanding of quality management principles, methodologies, and tools, with specific knowledge of ISO 9001, IATF, and internal auditing standards. Proficiency in quality management systems (e.g., ISO 9001) and regulatory requirements. Experience in coordinating external audits and certifications related to ISO 9001 and IATF standards. Excellent analytical and problem-solving skills. Effective communication and interpersonal skills. Ability to lead and motivate cross-functional teams. Additional qualifications: Certification in quality management (e.g., Six Sigma, ASQ) is desirable but not required. Key Competencies: Attention to detail and a commitment to excellence. Strong leadership and decision-making abilities. Ability to work collaboratively in a fast-paced environment. Results-oriented with a focus on continuous improvement. Benefits: Competitive salary commensurate with experience. Comprehensive benefits package including health insurance and retirement plans. Opportunities for professional development and advancement within the company.