Quality Operations Specialist MCB

Key Responsibilities

• Manage and report all Quality Metrics for the Molecular Cell Biology teamincluding Exceptions CAPAs Change Controls and SOPsensuring all actions are assigned tracked and closed in line with company compliance requirements.
• Review and approve all relevant Quality documentation for the Molecular Cell Biology department such as Exceptions CAPAs SOPs and quality/technical agreements.
• Lead and participate in crossfunctional risk assessments as required.
• Support and lead problemsolving activities within the department ensuring effective collaboration across functions.
• Ensure processes and systems are in place to complete Quality- and CAPArelated project work and produce customer reports in a timely manner.
• Provide continuous feedback to team members regarding customer expectations quality requirements and process changes.
• Manage the completion of compendia update assessments for the department.
• Support department leadership in maintaining the quality of daily laboratory work and collaborate with team members to resolve any quality-related issues.
• Manage assigned customer queries lead complaint investigations and work with the team to identify and resolve root causes.
• Support internal and external/regulatory audits including preparation participation responding to audit queries and driving corrective actions to closure.
• Represent the Molecular Cell Biology department at Change Control Review Boards and equipment meetings ensuring actions are assigned and tracked appropriately.
• Approve and maintain uptodate laboratory SOPs within your area of responsibility.
• Identify opportunities to enhance quality efficiency and customer service and support the implementation of continuous improvement initiatives.
• Establish and monitor key metrics related to quality and customer satisfaction/delivery ensuring targets are met and trends are proactively addressed.
• Ensure all team documentation is accurate complete up to date and compliant with company procedures.
• Communicate regularly with the team and supporting departments to ensure effective information flow throughout the organisation.
• Provide coaching and mentoring to improve understanding and compliance with quality standards.
• Review data in accordance with regulatory requirements analytical procedures and documentation standards.
• Review and accurately prepare reports for technological projects ensuring confidentiality and timely delivery to clients.

Qualifications :

Education / Qualifications

• Primary degree or equivalent in a related life sciences discipline
• At least 3 years experience in a GMP regulated environment
• Working knowledge of pharmaceutical quality systems
• Ability to work independently or as part of a team.
• Excellent report writing communication and organisational skills.
• Quality oriented with the ability to consistently work to industry and client standards.
• Positive and tenacious approach to work.
• Highly organised methodical and systematic approach to work.
• Passionate about quality and customer service.
• Good communication skills both internally and externally. Ability to understand clients requirements and to be able to devise and articulate the most appropriate solutions

Additional Information :

Eurofins Scientific is an international life sciences company providing a unique range of analytical testing services to clients across multiple industries to make life and our environment safer healthier and more sustainable. From the food you eat to the water you drink to the medicines you rely on Eurofins works with the biggest companies in the world to ensure the products they supply are safe their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food environmental pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics discovery pharmacology forensics CDMO advanced material sciences and in the support of clinical studies.

In over just 30 years Eurofins has grown from one laboratory in Nantes France to over 61000 staff across a network of more than 1000 independent companies in over 61 countries and operating more than 900 laboratories. Eurofins offers a portfolio of over 200000 analytical methods to evaluate the safety identity composition authenticity origin traceability and purity of biological substances and products as well as providing innovative clinical diagnostic testing services as one of the leading global emerging players in specialised clinical diagnostics testing.

Remote Work :

No

Employment Type :

Full-time