Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.
In order to achieve this, we will develop Idorsia into one of Europes leading biopharmaceutical company, with a strong scientific core.
Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet the ideal constellation to bringing R&D efforts to business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets.
We are looking for a pragmatic and enthusiastic QA Auditor and Compliance Manager GMP
Job Responsibilities :
Ensure GMP compliance at third party service providers and within internal facilities
Lead or assist in establishing external QA Audit and internal self-inspection annual Plan
Conduct GMP/GDP audit and self-inspections and coordinate with internal personnel and suppliers to schedule, execute and follow up with audit observations
Promptly report critical self-inspection findings to the Responsible Person and Management
Create, implement, maintain, and work with Vendors on establishing Quality Agreements where needed.
Interface between quality/regulatory/compliance personnel and operations to identify applicable regulatory and compliance requirements and ensure accurate understanding of those requirements.
Manage, review and approve change controls, deviations and CAPAs related to the internal pharmaceutical operations facilities (not project specific)
Write, review, and/or approve internal SOPs governing compliance related operations and other GMP/GDP and regulatory related documentation
Provides Quality oversight over equipment qualification, calibration and validation.
Support the preparation of Regulatory Authority Inspections
Monitor changes in quality regulations and initiate required activities to maintain compliance of the quality system
Support optimization of Idorsia's pharmaceutical quality system by working with cross-functional teams to obtain key performance indicators for the site and support the organization of Quality Management Review (QMR) meeting to communicate these metrics.
Promote GxP and Quality mindset at all levels within the organization.
Traveling (up to 30%) may be required, including international travel.
Candidates Requirements :
University degree in Pharmacy, Chemistry or alternative technical/science university degree: master level minimum
Minimum 3 years experience in Auditing , 1 as Lead Auditor
Knowledge and understanding of drug product development, manufacturing processes, as well as quality control, packaging and distribution aspects
Excellent knowledge of relevant GMP/GDP and international quality regulations e.g. ICH, ISO, WHO, PIC, FDA, EU GMP Guide (EudraLex Vol. 4), EU GDP and ability to interpret and implement quality standards
Ability to work on multiple projects with various disciplines and to manage complex projects and prioritize workloads according to the project importance
Attention to detail, organization, multi-tasking, and comfort interacting with people who might be junior or senior to the incumbent.
Ability to pro-actively initiate and lead quality compliance activities
Self-confident, assertiveness and autonomy to deal with complex stakeholders/situations Strong interpersonal and influencing skills
Fluent verbal and written communication skills in English and at least basic knowledge of an additional European language e.g. German or French
Experience in Medical Devices is a plus
What Idorsia offers
Exciting opportunities for development and professional growth within our dynamic organization
A collaborative and solution-oriented environment where you can make a difference
An innovative and open culture in a truly multicultural environment
A competitive salary and generous social benefits
Work Location: Allschwil
Business Area: Pharmaceutical Development and Commercial Supplies, QA Compliance Group
Job Type: Permanent
Job Code : 1442
If you are interested, please click on apply now.
Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.
Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.