Quality Control Subject Matter Expert
4 days ago
About No deviation
At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.
We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.
Position Overview
We are looking for a QC SME who will be responsible for ensuring the successful implementation and integration of gLIMS at the site by conducting thorough gap assessments and leading the required local process adjustments.
Key Responsibilities
- Perform gap assessments at the process and Standard Operating Procedure (SOP) levels.
- Collaborate with local teams, including MSAT and production, to identify necessary changes to existing processes, documentation, and data.
- Define, coordinate, and track actions to address identified gaps in a timely manner prior to roll-out.
- Develop and update local procedures for Quality and QC as required.
- Lead efforts to consolidate consumables, suppliers, instruments, etc., to reduce data load.
- Oversee data cleansing activities to ensure data integrity and accuracy.
- Manage updates and replacements of QC lab instruments (including firmware updates) to maintain secure system connections.
- Support the Change Manager by providing information, communication, and training to shop floor staff.
Required Qualifications
- Extensive experience in Quality Control and familiarity with gLIMS process descriptions.
- Strong analytical skills to identify local gaps and propose effective solutions.
- Excellent communication and collaboration skills to work with various stakeholders.
- Experience in writing and updating local work instructions and procedures.
- Empowered to make decisions for the site/department
Why join us?
- Generous Leave Policy including Elderly Care Leave to care for aging family members, reflecting our commitment to family wellbeing.
- Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
- Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
- Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
- Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.
How to apply
Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team
Please submit your resume, outlining your qualifications and experience relevant to the role, here.
Tell employers what skills you have
Analytical Approach
Pharmaceutical Industry
Audit and Compliance
Quality Control
Analytical Skills
Rollout
Consumables
Operational Risk Management
European Union
Firmware
Team Management
Operational Risk
Wellbeing
Stress Testing
Commissioning
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