A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
The Senior Quality Specialist role is to promote and integrate quality into every aspect of our business. The role involves the development and maintenance of the quality systems to ensure that we are operating in full compliance with sound scientific practice, GxP and standard operating procedures.
You will perform a variety of tasks in support of specific areas of the quality system within QA Compliance (client, supplier, and internal audits), influencing and impacting within QA and across a variety of operations departments regarding GXP compliance.
The operational activities will include:
- Providing leadership as a QA professional and provide, promote and display basic principles of good behaviour.
- Line management of small team
- Ensuring the regulatory compliance of the company by reviewing and approving all types of company documentation, providing input on the interpretation of requirements and the impact they have on company processes and systems, and ensure the maintenance of regulatory compliance during the change control process.
- Providing leadership or input into Quality Improvement Projects as assigned by company management and conduct or assist in investigations from Deviations, Complaints, Audits.
- Ensuring the regulatory compliance of the company by reviewing and approving all types of company QMS documentation, including: Events (Deviations and Out of Specifications), CAPAs, Investigations; Change control, Effectiveness checks, Risk Assessments, Validations, Material disposition, Complaints and Quality Agreements.
- Preparing appropriate SOP and training modules when required and carry out the training.
- Ensuring duties are carried out according to the principles of GLP and GMP and comply with all applicable policies, procedures and guidelines.
- Providing QA support for client conference calls regarding study / production compliance
- Proactively working with Operational Groups to make improvements to documentation and/or compliance based on audit findings
- Performing the review /approval of GxP documents, including protocols, technical specification (TS), batch records, workbooks, SOPs, validation protocols, and all other QMS documentation for auditing requirements.
- Performing the review and approval of completed manufacturing or testing documentation as they comply with the stated regulatory standard and the approved TS, protocol or SOPs.
- Conducting or assisting with Systems Inspections, to monitor performance, compliance with relevant regulations and safety practices and ensure continuous improvement
Who you are:
- You will have a Degree or equivalent in Biological Science or Quality Management.
- Significant experience of working in Quality Assurance or related field within a GxP regulated environment.
- Knowledge and application of FDA and EU regulations (cGMP, GLP, Part 11, Data Integrity)
- Excellent attention to detail is essential as well as logical in thought.
- Ability to work in a fast paced and changing environment.
- Excellent oral and written communication skills.
- Advanced working knowledge of good documentation practices
- Strong Oral, written communication and interpersonal skills required
- Capable of making quality related decisions and provide guidance in areas of expertise
- Capable of implementing process improvements
- Presentation, interpersonal communication skills
- Ability to set own work schedules to manage time and prioritise workload effectively. To challenge unrealistic deadlines and ability to influence workload. Taking on additional workload such as responsibilities, project or business initiative.
- Working knowledge of continuous improvement tools and methodology.
- Ability to help and support colleagues cross functionally on operational and transactional tasks.
• Ability to train and develop functional skills in others and to lead in cross functional projects.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
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