Quality Projects Manager

We are currently looking for an experienced Quality Projects Manager to be join our team

The Quality Projects Manager will implement both Global and local Quality projects using appropriate systems, tools and methodologies, which deliver Quality projects on time. Will interact, and work with as required, QC, QA, Validation, site functions and Global Quality as necessary.

Key responsibilities:

• Continuously manage multiple projects directly impacting Quality, creating the project plan, defining and managing the resource required
• To lead, analyse, define, execute and implement project plans along with the project teams
• Coordinate the project portfolio on behalf of the Quality Unit
• Be a knowledgeable resource to the Quality Unit and site regarding project management, coaching and mentoring others in project management
• Responsible for reporting on project progress to the Quality Leadership Team, Global Quality and SLT and escalation of issues when they occur
• A key point of contact for Global Quality interactions
• Report to site and global quality on the progress of initiatives

What we need you to have:

• BSc Qualified within Life Sciences
  Qualification in Project Management is an advantage
• Extensive hands on experience within and delivering Project/Proposals Management
• Ability to work with cross-functional teams across the business

Quality Systems Expert

The Quality Systems Expert will provide QA oversight of the Pharmaceutical Quality System (PQS) whilst managing and support GMP issues through the PQS and site governance mechanisms to support Site operations and Senior QA leadership.

Key responsibilities:

• Use knowledge of GMP and quality processes to actively identify, suggest, participate in and manage continuous improvement to ensure that PQS remains effective, efficient, simple and compliant
• Monitor, analyze and interpret Site quality metrics and ongoing quality trends for risks and deviations to provide information to the Site.
• Ensure actions are taken in a timely manner to address trends and when issues are highlighted.
• Lead and support Site QMS governance processes
• Actively develop, mentor, train and enforce a site GMP culture within Operations.
• Support regulatory and customer audits of the Operations areas and processes
• Identify opportunities for GMP compliance training and awareness campaigns – design, develop and deliver.
• Drive continuous improvement and ‘fitness for purpose’ for the PQS.
• Deputise for PQS group lead
• Ensuring technical accuracy and GMP compliance

What we need you to have:

• Degree (or equivalent) in Biology.
  Previous work experience in QA / GMP is essential
• Experience working with Quality Systems such as Trackwise and Document management system.
• Experience managing Quality Records to completion
• Experience working with teams to make improvements the Quality management systems such as deviations
• Project management experience is desirable
• Demonstration of workload prioritisation skills, decision-making and scheduling skills.
• Ability to meet strict deadlines.
• Developing decision-making and problem-solving skills.
• Good organisational & planning skills.
• IT literate – MS Office – Word, Explorer, Excel, Access, Outlook.
• Database familiarity with data entry/searches/queries.

Quality Assurance Manager

We are currently looking for an experienced Quality Assurance Manager.

Reporting to the Head of External Quality, in this role you will have specific responsibility for overall regulatory, customer inspection and audit management. The brief will focus on leading, managing and overseeing regulatory inspections, customer audits, managing, and supporting site leadership throughout the inspection/audit process to ensure optimal outcomes and a state of continuous inspection readiness.

Providing a focal point for all inspection and audit-related activity and for coordinating follow-up and responses to observations, a key priority will be to improve the efficiency with which these activities are managed. As well as reviewing current practices, you will be encouraged to collaborate with colleagues from across the network to incorporate their learnings. You will also need to build and maintain productive relationships with the Global Quality Assurance (GQA) team to enhance knowledge sharing and improve response times.

Key responsibilities:

• Manage regulatory inspections and customer audits.
• Advise, guide and support the site in the overall inspection management
• Manage site preparation for inspections and audits
• Organise and run the Back Room during audits
• Manage any outcomes/findings, ensure appropriate responses liaising with customers and Global Quality Assurance (GQA)
• Provide guidance for timely remediation and support response writing
• Work with QA and other departments to ensure that CAPA raised as a result of the above are SMART and that CAPAs are closed by the due dates.
• Responsible for leading the Site responses to the Global regulatory gap analysis
• Prepare and review regulatory inspection evidence files

What we need you to have:

• Bachelor’s degree (or equivalent) in a scientific or QA-related discipline
• Significant experience working within QA roles in GMP-regulated pharmaceutical – ideally biologics or biopharmaceutical – environments
• Significant experience managing regulatory (e.g., MHRA & US FDA, etc.) inspections.
• Experience working with drug substances
• Ability to meet strict deadlines.
• Ability to work in a team and solo capacity.
• Significant experience in risk management and project management.

QA Specialist

We have a great opportunity available for a QA Specialist – to join our QA Operations team, which is part of our Quality Assurance Department. This is a permanent position based out of our state-of-the-art Slough facility.

As a QA Associate – Batch Review you will be part of a team ensuring that quality is maintained at an appropriate level meeting customer and regulatory expectations and enabling the site to deliver to relevant targets.

Key Responsibilities:

• Auditing documentation generated during manufacturing processes and for ancillary areas of manufacturing, co-ordinating of review and any follow-up action or corrections of GMP documentation
• Auditing documentation generated from the Analytical Services, Purification Development and Quality Control departments
• Acting as a point of contact for general queries relating to quality and escalating as required
• Expand and utilise knowledge of quality procedures to identify and report non-conformances and resolve issues arising in the area via interaction with the relevant personnel
• Raw material release
• Ensure current GMP requirements for all areas are met
• Assist in the preparation of the area for inspection readiness
• Advising operators on best practises for document completion, review and follow-up actions or escalating if required

Key Requirements:

• BSc or equivalent in a biology-related field
• Experience working within QA ideally in a manufacturing environment with good knowledge of GMP.
• Working experience with Biologics.
• Great attention to detail
• Demonstration of workload prioritisation skills, decision-making and scheduling skills

QA Scientist

We have a great opportunity available for a QA Specialist – to join our QA Operations team, which is part of our Quality Assurance Department. This is a permanent position based out of our state-of-the-art Slough facility.

As a QA Associate – Batch Review you will be part of a team ensuring that quality is maintained at an appropriate level meeting customer and regulatory expectations and enabling the site to deliver to relevant targets.

Key Responsibilities:

• Auditing documentation generated during manufacturing processes and for ancillary areas of manufacturing, co-ordinating of review and any follow-up action or corrections of GMP documentation
• Auditing documentation generated from the Analytical Services, Purification Development and Quality Control departments
• Acting as a point of contact for general queries relating to quality and escalating as required
• Expand and utilise knowledge of quality procedures to identify and report non-conformances and resolve issues arising in the area via interaction with the relevant personnel
• Raw material release
• Ensure current GMP requirements for all areas are met
• Assist in the preparation of the area for inspection readiness
• Advising operators on best practises for document completion, review and follow-up actions or escalating if required

Key Requirements:

• BSc or equivalent in a biology-related field
• Experience working within QA ideally in a manufacturing environment with good knowledge of GMP.
• Working experience with Biologics.
• Great attention to detail
• Demonstration of workload prioritisation skills, decision-making and scheduling skills