Sr GMP GDP Auditor
Sr GMP GDP Auditor
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Job Description
The purpose of the position is to perform GMP GDP Audits (GMP GDP) and contribute to develop and maintain
the global Sobi GMP GDP audit strategy and audit program(s). The audits will be both internal audits/self
inspections within Sobis QMS as well as external audits of Sobis CMOs suppliers and service providers. The
employee will also have the main responsibility for the administration of audits and audit programs and plannings
in the computerised systems at Sobi.
Key Responsibilities
Drive strategic development of an effective global riskbased audit strategy (internal & external) and
program. Collect collate and incorporate input into the audit strategy and plan.
Plan lead conduct document and followup of internal and external GMP GDP audits (Primarily
dedicated to GMP/GDP) as Lead Auditor or Co Auditor of Sobis CMOs suppliers and service providers)
according to the requirements specified in the respective Sobi procedures (as well as applicable
regulations standards quality agreements and guidance documents) working ins strong collaboration
with the GMP GDP Audit coordinator and relevant stakeholders.
Lead Auditor or Co Auditor of internal audits/selfinspections within Sobis QMS as well as
Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the
proposed filing
Ensure appropriate escalation to responsible management in case of critical findings and support
immediate followup. Ensure adequate definition and recording of mitigation plans when applicable.
Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the GMP GDP Audit
coordinator and other stakeholder QA representative and Auditee.
Prepare regular status report on performed GMP GDP audits (Primarily dedicated to GMP/GDP) audit
trending and agreed upon metrics to ensure oversight.
Support Authority inspections and partner audits
Maintain knowledge of company policies SOPs and supporting documents related to drug
development/manufacturing/distribution as well as FDA and EU regulations and ICH guidance documents
(as applicable) along with any other national or international regulations
SOP Author for SOPs related to GMP GDP audits including supporting documents Act as GMP GDP
compliance consultant for GMP GDP trainings task forces continuous improvement projects as needed.
Act as GMP GDP compliance consultant for GMP GDP trainings task forces continuous improvement projects as needed.
Qualifications :
Education/Learning Experience/Work Experience
University degree in Life Sciences or related discipline.
At least 10 years experience from the pharmaceutical industry with GMP/GDP responsibilities.
Experience of Lead GMP GDP audits/inspections.
Experience working as GMP GDP Inspector or Auditor in the field of Biotechnology and Sterile
Manufacturing
Skills/Knowledge/Languages
Excellent knowhow of the EU/US/RoW regulations within GMP GDP
Excellent verbal and written communication skills
Excellent knowledge in document handling in computerised systems
Personal Attributes
Delivery focus
Collaborative
Structured and detail oriented
Strong individual initiative organizational/people skills and multitasking abilities
Ownership paternership and sense of urgency
Additional Comments
The position require ability and willingness to travel in connection with performing onsite audits.
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 here 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
