Professional III, Quality Assurance

Aptar; Cwmbran; On-site; GBP 60,000 - 90,000; Full time

Job summary

Aptar Nanopharm is seeking a Quality Assurance Manager to lead the QA function within the Pharmaceutical Quality System (PQS) in Wales. The role requires ensuring GMP compliance, data integrity, and effective QA governance for client projects in inhalation products development.

You will line-manage QA Analysts, drive CAPA, change controls, and internal audits, and coordinate with Project Management, Development, and Operations to maintain high-quality analytical services and regulatory readiness.

Responsibilities

• Lead a team of Quality Assurance Analysts to align with strategy and oversee QA activities.
• Schedule resources to deliver department responsibilities in line with quality objectives.
• Oversee implementation of company policies ensuring fair, compliant operations.

Job description

Nanopharm operates a fee-for-service model, helping its clients navigate the scientific, technical and regulatory challenges in developing nasal and respiratory drug products from discovery through to clinical investigations ('IND'). Its service offerings provide the most efficient path to success for its clients by providing an integrated product development service covering:

• Advanced materials characterization
• Analytical method development
• Formulation development and testing
• Inhaled biopharmaceutics

These early phase services aid successful product development by understanding how material properties and processing conditions influence product functionality and therefore reduce risks and expedite drug development timelines. Nanopharm's proprietary technology and analytical platforms for advanced materials characterization, formulation & device development and in-silico modelling of in vivo behaviour, have provided Nanopharm a technical competitive edge, helping it become an international market leader. For more information visit: www.nanopharm.co.uk

You should work here because we:

• Attract and develop high performing people.
• Promote a diverse and inclusive work environment.
• Allow for failure by allowing people to make mistakes through an open and trusting environment.
• Invest in the development of employees through local, regional and global career opportunities.
• Contribute to the communities where we reside.

What's new with Aptar Nanopharm is a prominent player in the Inhalation industry, with our laboratory service provision in Wales, United Kingdom. We specialise in the development and testing of inhalable and nasal pharmaceutical products, collaborating closely with pharmaceutical companies to ensure product safety, efficacy, and regulatory compliance. We have an exciting position open at Nanopharm, which is an Aptar Pharma Company: Professional III, Quality Assurance reporting into Manager, Quality. These positions will be based in Cwmbran and will involve conducting pharmaceutical product analysis for our customers to a high degree of precision and efficiency.

This is how your journey begins: Role Overview This position is primarily responsible for:

• The day-to-day management and implementation of a comprehensive formal Quality Management System (QMS) within the Pharmaceutical Quality System (PQS), as aligned with Good Manufacturing Practice (GMP)
• Resourcing QA tasks, supervising staff within QA and assisting other members of staff throughout the business in conducting work in a compliant manner to ensure customer satisfaction.
• Line management of your assigned team

Job Details / Responsibilities

Job descriptions cover approximately 85% of a role and are not an exhaustive list of responsibilities and duties. You are expected to carry out other activities that are within reasonable scope of the role.

• Lead a team of Quality Assurance Analysts in order to align with strategy as set by Manager, Quality and other members of the Senior Leadership Team (SLT)
• Responsible for day-to day scheduling of resources to deliver department responsibilities, in alignment with Nanopharm's Company goals and quality objectives
• Supervising activities within the QA team to ensure effective operation of the department
• Overseeing implementation of Company policies in a fair and consistent manner, including attendance and performance management
• Ensure that assigned staff are appropriately trained for their roles and have appropriate training and development plans
• Promote engagement and participation of staff at all levels to allow expression of opinion and feedback
• Promote GMP standards to ensure Nanopharm has a strong compliance culture
• Collaborate with Project Management, Pharmaceutical Development, Specialist, and Operations teams and other departments to ensure alignment on business objectives and seamless project execution
• Review data for technical quality and compliance of protocols, methods and Standard Operating Procedures (SOPs)
• Approve reports and certificates of analysis (CoA) for QA
• Review and approve QMS records, including change controls, deviations, root cause analysis, laboratory investigations, CAPA and risk assessments
• Ensuring your team's on-time completion/closure of all assigned QMS records, leading by example in this area
• Maintain QMS spreadsheets to monitor on time completion of QMS activities and allow accessible generation of track & trend metrics
• Contributing to Quality Management Review discussions with senior management after collating Quality metrics and business KPIs
• Ensure that internal audits are carried out to the approved schedule and that observation reports are provided to the responsible Manager according to Nanopharm's Self-Inspection procedure
• Manage responses received and monitor on time completion of derived actions within the process
• Manage internal documentation, including the maintenance of Standard Operating Procedures and other controlled documents
• Oversee review and approval of qualification records alongside operations
• Provide Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) induction to all new starters when detailed by Manager, Quality
• Deliver GMP refresher training at least once in each calendar year when detailed by Manager, Quality
• Provide training in key QA processes and to support the introduction of new initiatives
• Promote systems and processes that ensure data integrity throughout the data lifecycle, including alignment with ALCOA+ and Computerised System Validation (CSV), including data recording of your assigned team
• Act as system owner for assigned computerised systems
• Administer the document control system, ensuring all new staff have access and appropriate permissions in accordance to relevant SOPs
• Author assigned SOPs and other relevant documents
• Approve SOPs and other relevant documents for QA
• Keep approval of suppliers and contractors up to date
• Assist Manager, Quality with hosting Customer Audits and Regulatory Inspections and lead timely response to any observations received. Host these visits when assigned, including discussion of agendas with customers
• Assisting with the review and processing of Quality Technical Agreements (QTAs).
• Assist where necessary in the application and subsequent maintenance of GMP registration and accreditation and developing relationships with the regulatory bodies, e.g. Medicines and Healthcare products Regulatory Agency (MHRA) & Food and Drug Administration (FDA)
• Escalating issues, such as any areas of non-compliance to Manager, Quality, where appropriate
• Identifying areas where improvements can be made and assisting members of the SLT in implementing identified improvements
• Oversee assigned staff to ensure efficient conduct of procedures supporting the conduct of work. Examples include, but are not limited to: data corrections, receipt of standards and samples, issue of lab books, assisting with production of analytical testing sheets (ATS), etc.
• Keep abreast of developments in relevant regulations
• Generating Purchase Requisitions for QA materials in accordance with Nanopharm and Aptar systems

Basics

• Always promote Nanopharm & Aptar's best interests by the positive and effective way you perform your duties modelling our Core Values and Rules of Leadership.
• Always comply and proactively engage with Environment, Health, Safety and Sustainability policies, procedures and instructions to ensure the safety of you and your colleagues.
• Always comply and proactively engage with Quality policies, procedures and instructions to ensure we deliver quality work, data and reports.
• Read and understand all assigned Standard Operating Procedures (SOPs) via the Quality Management System (QMS) in the timeframe specified.
• Maintain an up-to-date training record and submit to your line manager at least