Qms Manager

My client, a modern and vibrant Pharmaceutical business in Cambridge, is looking to recruit a dynamic QMS Manager to help support the team. As the QMS Manager, you will play a crucial role in making sure that the quality and compliance are done according to regulatory needs.

Job Responsibilities

• Manage and maintain the Pharma Quality System (PQS) incorporating Good Manufacturing Practice, Good Distribution Practices and Quality Risk Management to support the Manufacturing and Importation Authorization/wholesale dealer licenses and controlled drug licenses as owned by the UK and Netherlands PCC Limited sites.
• Own and manage the required GMP and GDP documentation and the QA processes as defined in the approved and implemented QMS documentation.
• Support QP function to discharge their duties.
• Effectively manage the investigations into deviations, out of specification results and the change requests for completion, accurate and effective assignment of CAPA plans and actions to implement changes, monitor the effectiveness and review the changes to confirm if the desired outcome has been achieved without negative impact on to the QMS/product/compliance/safety.
• To develop and report appropriate KPls as relevant to the owned GMP/GDP processes and enable visibility to the QP/RP functions and PCC business onto such processes in order to evaluate the compliance status of the sites in line with the current regulatory requirements.
• Organise and participate in the Quality management reviews and ensure all supporting data is presented and the assigned actions are completed on time.
• Participate in the vendor management process as a supporting function, in accordance with the knowledge and experience and activity assigned and agreed upon with the process owner.
• Manage and maintain an effective and efficient self-inspection program and ensure the internal audits are performed on time as scheduled, the relevant actions are completed in an effective and timely manner, by the relevant owners.
• Actively participate to all relevant activities required to ensure data integrity is continuously maintained and adequately controlled on site.
• Ensure the QMS documentation is stored and archived following the relevant GMP and GDP requirements and the quality documentation control process is effective and efficient.
• Ensure the quality agreements between PCC and relevant supply chain parties or service providers are issued and maintained.
• Ensure support in the new products/projects onboarding activities as requested by the business and within the quality organization.
• Ensure support on QMS related topics across the EU PCC sites and take the lead role in the harmonization of the QMS documentation and processes across PCC EU sites.
• Adhere to the corporate guidelines and ensure the PCC core Quality organization culture is enabled and embedded in the quality systems documentation as well as part of the organization behavior as a whole.
• Keep up to date with the most current regulatory requirements and own knowledge to enable the discharge of the relevant role duties.

Qualifications and experience

• Good technical knowledge of GMP, regulations and guidelines. Experienced in the management and maintenance of an EU regulatory-approved QMS.
• Highly collaborative, regular interaction with the named QP, Regulatory groups, QPPV, Supply chain, site-based QA, distributors, testing labs, warehouses, sales departments, customers, MA holders and regulators.
• Ability to work independently with limited supervision, self-driven, responsive and results-orientated.
• GMP auditing knowledge and practical skills, both hosting and performing.
• Good team player, positive attitude and the ability to be flexible.
• Excellent communication skills (written and verbal).
• Ability to work under pressure in a fast-moving work environment.
• Qualification Requirements
• Minimum a BSc degree in life science.
• Minimum 3 years' experience in a similar Quality Assurance role within the Pharma Industry.
• Relevant GMP training as required to discharge assigned duties and responsibilities.

To apply, please email a copy of your CV along with details of your salary expectations and notice period.