GMP/GDP QA Manager Drug Products - Combination Products
About Idorsia Pharmaceuticals Ltd
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 Europe's 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 an enthusiastic and motivated GMP/GDP QA Manager Drug Products - Combination Products to join our team !
Provide GMP/GDP expertise thus ensuring that medicinal products are developed, manufactured, packed, labelled, distributed and controlled in accordance with regulatory expectations and applicable quality standards
Perform GMP onsite audits at Contract Manufacturing Organizations (CMOs)
Preparation of Quality Agreements in collaboration with CMOs and the CMC team
Prepare, review, and/or approve internal SOPs and other GMP/GDP related documentation
Execute QA activities to support release of active ingredients, investigational medicinal products including approval of master process documentation, batch record review, resolution of investigations, and assessment of change controls
Establish a quality risk management approach in projects based on ICH Q9 concepts to ensure that quality is understood and managed by all stakeholders throughout the product life cycle
For assigned projects, ensure resolution of deviations, complaints, testing issues, discrepancies, Out of Specifications (OOS) and Corrective and Preventive Actions (CAPA)
Notify management of potential quality and regulatory issues
Support the review and optimization of the company's pharmaceutical quality system by establishing relevant Key Performance Indicators.
Advanced University degree in Pharmacy (preferred), Chemistry or alternative technical/science university degree
Minimum of 5 years' experience in different positions like pharmaceutical or chemical development, quality control, analytical development, chemical or pharmaceutical production or similar operational positions in the pharmaceutical industry
In addition, minimum of 3 years' experience in quality assurance of drug product covering also combination products
Excellent knowledge of GMP and GDP requirements, ability to interpret and implement quality standards
Knowledge of drug product manufacturing, control, packaging and distribution procedures
Strong interpersonal and influencing skills
Excellent verbal and written communication skills in English
Ability to manage multiple tasks with competing priorities
Entrepreneurial mind set combined with cost consciousness
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: Quality Assurance
Job Type: Permanent
Job Code : 2523
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.