Sr GMP GDP Auditor

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases.

As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo.

We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development.

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 Sobi’s QMS as well as external audits of Sobi’s 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 risk-based audit strategy (internal & external) and

program. Collect, collate, and incorporate input into the audit strategy and plan.

- Plan, lead, conduct, document, and follow-up of internal and external GMP GDP audits (Primarily

dedicated to GMP/GDP) as Lead Auditor or Co Auditor of Sobi’s 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/self-inspections within Sobi’s 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 follow-up. 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 multi-tasking abilities

· Ownership, paternership and sense of urgency

Additional Comments

The position require ability and willingness to travel in connection with performing on-site audits.

Additional Information

How to apply

At Sobi, we value work-life 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