Quality Audit

vor 4 Wochen

St Gallen, Schweiz CSL Vollzeit

Title: Auditor (Senior), External Supplier Quality

Location: St. Gallen, Switzerland (flexible/hybrid work model)

Type of role: Permanent position

We are looking for a (Senior) Auditor External Supplier Quality to join our Quality team in St. Gallen on a permanent basis. You will support the local site regarding supplier/third-party qualification status and process and will report directly to the Head of Supplier Quality Management (CH). We are offering a flexible and hybrid working model.

Main Accountabilities

· Through remote/desk audit process, executes GxP quality systems audits of approved and potential suppliers of raw materials, components, suppliers and service providers for the CSL Sites. May also perform local Site audits. 

· Prepares audit report and assigns levels of compliance to each observed action based on established criteria. Delivers audit results to suppliers, according to internal CSL timelines. Evaluates supplier corrective action plans to ensure plans satisfactorily address the observation(s) and ensure the corresponding follow-up.

· Responsible for interpreting and making decisions based on company policies and procedures, regulatory agencies, local, state, federal and international regulations.

· Responsible for supplier quality agreements, global and local, which include writing, editing, reviewing, updating and routing the agreements for approvals between CSL Sites, service providers and suppliers. 

Bring/maintain the suppliers/third parties to the expected level of compliance.

Key Tasks

· Local Point of Contact for External Supplier Quality (ESQ) organization.

· Plan, execute and follow-up assigned audits.

· Revise, edit and route for signature Quality Agreements as assigned.

· Supplier-related complaints follow-up (tracking, investigation completion and proper CAPA plan).

· Supplier improvement plans where applicable.

Your Profile

Minimum Requirements

· Requires a four-year degree in a relevant business or science, or equivalent education and experience.

· Minimum of 3 years’ experience in a GxP environment in the pharmaceutical industry.

· Thorough understanding of required regulations including FDA, PiC/S and European regulation, Therapeutics Goods Authority, Canadian Health Authority, etc.

· Industry and auditing knowledge (internal and external), with relevant evidence.

· Must be comfortable working in a global, matrix organization.

· Fluent in English (written and spoken). Other languages (German, French) would be an asset.

Preferred Requirements

· 3-5 year-experience in a QA role in a pharmaceutical company, including global and/or regional audit responsibility.

· Knowledge of Quality Systems and Supplier Management.

· Knowledge and experience in sterile and non-sterile product manufacturing, biological processes, laboratory operations, distribution.

· Demonstrated ability to interact with and gain the support of senior management, global partners, and cross-functional teams.

· In-depth knowledge of the regulatory environment for the manufacture of drugs.

Are you interested and recognize yourself in the above profile? We are looking forward in receiving your online application.

About CSL Vifor

CSL Vifor aims to become the global leader in iron deficiency and nephrology.

The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.

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