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Form of work
SalaryAbout 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.
- 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
