Quality Engineer and GxP e-Compliance Specialist
Quality Engineer and GxP e-Compliance Specialist
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Job Description
As the Quality Engineer and GxP eCompliance Specialist you will play a pivotal role in ensuring eCompliance and driving digital quality decisions through effective GxP system lifecycle management and quality data stewardship. This role will support the companys vision of Ensure eCompliance and Goes digital to enable Quality decisions driven by data by overseeing GxP systems and its data processed in GMP GDP GCP and GVP field and to ensure the lifecycle for appropriate governance and oversight. The specialist will also act as a business admin for Veeva QMS SQM and training modules.
The role reports to our GxP eCompliance Manager.
Key Responsibilities
- Ensure eCompliance through comprehensive GxP system lifecycle management including acting as Business Admin for GxP systems (i.e. Veeva QMS SQM and training modules.
- Drive the digital Quality roadmap and process quality automation across the GxP arena. Collaborate with crossfunctional teams to identify opportunities for digital transformation and process improvements. Act as the business admin for Veeva QMS SQM and training modules. Ensure effective management and utilization of these systems to support quality and compliance objectives.
- Oversee Quality Data Stewards to ensure adherence to relevant quality and regulatory requirements within the GxP field. Ensure efficient collection processing display and storage of data making it readily available for Quality Management review to facilitate prompt decisionmaking and reporting to health authorities and partners during audits and inspections.
- Support the demands to maintain GxP learning processes and quality documentation processes including owning procedural documents and global work instructions for GxP training training matrix maintenance and GxP governing documents. Supporting manage document training distribution via LMS and maintain an active organization for local training admins (QCTCs).
- Implement Sobi standards and verify compliance through periodic reviews. Ensure adherence to current GxP and Sobi requirements. Evaluate and support the approval process of quality documents and records within Veeva.
- Support CSV activities (observing the segregation of duties) inspections internal audits followup activities and remediation guidance. Enable divisions and business units to implement global CSV standards. Represent Global QA for ecompliance standards within Sobi as a specialist
- Facilitate the streamlined integration of new companies and their GxP systems into our ecompliance framework by developing and implementing adaptive GxP processes ensuring regulatory compliance providing training to promote a culture of quality and compliance overseeing the refinement and adaptation of GMP processes for quality management of development products and ensuring efficient and compliant crossfunctional change control processes.
Qualifications :
We are seeking a detailoriented professional to ensure eCompliance through robust GxP system management and data stewardship. Strong analytical skills are required to drive digital quality initiatives and identify process improvements. Effective communication is essential for crossfunctional collaboration and supporting GxP documentation. The ideal candidate is proactive ensuring compliance with Sobi standards through regular reviews and adaptable facilitating the integration of new GxP systems. Problemsolving skills are key for supporting CSV activities and audits. A commitment to quality and continuous improvement is vital for refining GMP processes and managing compliant change control.
Key Qualifications
- Documented education in Natural science chemistry pharmacology pharmaceutical development IT or corresponding work experience within IT and or the GxP area/areas. Advanced competency for use IT systems and office suite.
- Minimum of 5 years of experience in GxP compliance quality assurance or a related field within the pharmaceutical industry.
- Strong knowledge of GxP processes and computerized system validation (CSV) standards.
- Experience with digital quality systems and tools including Veeva QMS SQM and training modules.
- Experience with digital transformation initiatives and process automation in the pharmaceutical industry.
- Excellent communication and interpersonal skills with the ability to collaborate effectively with crossfunctional teams.
- Fluent in English (written and oral)
Here at Sobi we live by our core values: Care Ambition Urgency Ownership and Partnership!
Additional Information :
How to apply
At Sobi we value worklife balance and due to the holidays it may take a little bit longer until you hear back from us.
We have an ongoing selection process in this recruitment and ask you to send your application as soon as possible. Click apply and include your resume in English.
Why Join Us
Here at Sobi our mission and culture get us excited to come to work every day but here are a few more reasons to join our team:
- Emphasis on work/life balance
- Collaborative and teamoriented environment
- Opportunities for professional growth
- Diversity and Inclusion
- Competitive compensation for your work
- Making a positive impact to help ultrarare disease patients who are in need of life saving treatments
We are a global company with over 1800 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our daytoday wins and a Board with a stellar track record were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre seeking a career that taps into your talents in a way that makes the world a better healthier place we just may have a job for you.
We know our employees are our most valuable asset and our culture conveys that. We offer a competitive benefits package to support the health and happiness of our staff.
Sobi Culture
At Sobi we refuse to accept the status quo. This is because we have witnessed firsthand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.
As a specialized biopharmaceutical company we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into groundbreaking treatments we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one but we know we cant change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients partners and stakeholders across the entire value chain. Together we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
