We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.
We have leveraged our expertise and capabilities both to commercialize three vaccines, including the world’s first and only chikungunya vaccine, and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease and Zika.
With operations in Austria, Canada, France, Sweden, the United Kingdom, and the U.S., we are committed to making a positive impact on global public health.
Together, we are a global Company which is open to people of all backgrounds. Our diverse and inclusive workforce makes Valneva a great place to work.
Our Quality Assurance Team are looking to add a QA Specialist into their team.
Assist in developing and maintaining a comprehensive and effective pharmaceutical quality management system to achieve regulatory compliance, product quality and inspection readiness.
Maintains an effective and compliant Supplier Quality Management system within Valneva Livingston to meet the requirements of the company, considering any regulatory requirements i.e. GDP, cGMP, FDA, MHRA, WHO, PIC/S and supporting other sites or corporate requirements in terms of supplier quality.
Maintaining the system: which includes planning and tracking supplier-related activities to ensure delivery to required timelines and targets; working internally with Valneva functions and externally with suppliers and service-providers to achieve improved regulatory compliance, service quality, GxP inspection readiness and efficiency / effectiveness of Valneva projects and objectives.
Executes Supplier Quality Management routine work that includes:
1. Qualification and Re-qualification activities for GxP impacting suppliers, starting materials and services.
2. Supplier Performance Monitoring in conjunction with Procurement and Supply Chain.
3. Preparation and review of Quality / Technical Agreements.
4. Leading the risk-based preparation, execution and monitoring of Valneva Livingston’s annual External Audit Schedule, with quarterly updates and drive closeout.
5. Maintenance of the site’s Approved Suppliers List / Register.
Performs activities, reviews and approvals within the QMS in accordance with relevant Standard Operating Procedures (SOPs), including but not limited to:
1. Documentation Management (including Issuing and reconciling GxP documentation, Archiving of GxP documentation, develop, monitor, improve, maintain procedures to ensure compliance with EU Good Documentation Practices for pharmaceutical products).
2. Supporting and taking part in Continuous Improvement activities (including digitalisation of GxP systems).
3. KPIs and Metrics (including delivery and presentation of key quality metrics for the site to support the QA Manager and the regular quality governance meetings).
4. Quality Training Management (including delivery of training in specific areas of own expertise where required).
5. Corrective and Preventive Actions (CAPA) (Including reviewing and assessing CAPAs, checking evidence of closeout and performing the required Effectiveness Checks, as necessary).
6. Risk Management (preparing impact and risk assessments, assessing criticality and workings, verifying mitigations and eliminating actions).
7. Change Control (reviewing proposed changes and risk assessments as well as change plans and associated resources, reviewing change plans for progress and performing effectiveness checks as required).
8. Quality Events (including checking QE reports, investigating, reviewing proposed CAPAs as appropriate and escalating to management as required).
9. Audits (Including providing support for audits of Valneva by partners/customers and regulatory bodies, perform internal and external audits).
10. Data Integrity in line with GMP regulations and Valneva requirements (including data governance, reported data integrity non-conformances, cybersecurity, records and archives as well as audit trail review).
Supports Valneva’s ESG principles: including environmental and occupational health as well as general health & safety requirements.
Actively contributes to the development and maintenance of a good quality culture on-site through providing positive example, applying appropriate mindset, proactive collaboration and communication with other departments.
Contributes to the compilation of and provide relevant references for the periodic Product Quality Reviews and the quality management reviews.
Undertakes any other reasonable duties as requested by the QA Manager (Quality Systems), in accordance with company requirements. Extended hours and out-of-normal hours work may be occasionally required.
Experience
* Educated to at least graduate degree level in a relevant discipline (Biology, Chemistry, Pharmaceutics, Biotechnology, Biochemistry, Pharmacy) or an equivalent scientific / technical vocational qualification.
* Preferably 3+ years’ experience in UK, EU, FDA or WHO cGMP / GDP requirements for Quality Management Systems.
* Experience of delivering to tight deadlines.
* Experience working on continuous quality improvement (CI).
* Experience in delivering key quality metrics and operating eQMS software / databases.
* Experience as an auditor (preferably a Lead Auditor) for Internal and External Quality Systems audit. ISO 9001 or GMP / GDP.
Required Skills
* Ability to focus and concentrate whilst paying attention to detail.
* Clear and effective verbal, written and presentation communication skills in English.
* Strong IT (e.g. MS Office) and eQMS (e.g. Smartsolve or Trackwise) knowledge.
* Logical and methodical / consistent approach to problem-solving.
* Pro-active initiative-taker with resilience to see projects through to successful outcomes.
* Ability to calmly plan, manage and progress workload unsupervised.
* Multi-tasking ability to work simultaneously on projects and routine assignments with changing priorities.
Benefits include:
* Stock Options
* Employee Assistance Programme
* Gym membership OR fitness allowance
* LinkedIn Learning
* Volunteering days
* Many others included
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