QA Compliance Manager

vor 1 Tag

Basel, Schweiz Idorsia Pharmaceuticals Ltd. Vollzeit

**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 want to develop Idorsia into one of Europe’s leading biopharmaceutical companies, 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 1,100 highly qualified specialists dedicated to realizing our ambitious targets.

We are looking for an enthusiastic and motivated **QA Compliance Manager(GMP/GDP) Manufacturing Facilities and QC Laboratories** to join our team

**Responsibilities**:

- Ensure compliance of QC Laboratories (including Microbiological laboratory) and support QA Compliance activities linked to solid and sterile manufacturing facilities (e.g. environmental monitoring, equipment and utilities qualification, SOPs, cleaning validation, validation protocols/reports review and approval)
- Verify GMP compliance within internal facilities, utilities, systems, equipment.
- Control and monitor Analytical and Microbiological QC Laboratories performances and evaluate quality control measures in place
- Promote high standards of good laboratory practices as well as good manufacturing practices
- Manage, review and approve change controls, deviations and CAPAs related to the internal pharmaceutical operations facilities (not project specific)
- Perform investigations and risk assessment to support deviations
- Manage, review and approve qualification & validation documents of GMP equipment (facilities and utilities)
- Write, review, and/or approve internal quality system SOPs and other GMP regulatory related documentation focusing on Laboratories and on the Manufacturing Units.
- Evaluate, develop, establish, and maintain internal processes and procedures for compliance with GMP standards and for process improvement (QS document including Quality agreements with third parties)
- Management of quality documents including use of EDMS systems for electronic records
- Contribute to the execution of external GMP audits and internal self-inspection program.
- Promptly report critical self-inspection findings to the Responsible Person and management
- Support the preparation and conduct of Regulatory Authority Inspections
- Monitor changes in quality regulations and initiate required activities to maintain compliance of the quality system
- Promote and participate actively to continuous quality improvements program
- University degree in Pharmacy, Chemistry, Microbiology, Pharmaceutical Engineering or alternative technical/science university degree: master level minimum
- Minimum 5 years of experience in different positions like pharmaceutical product development/ microbiological quality control/ analytical development/ chemical production or similar operational positions in the pharmaceutical industry
- Experience in Sterile manufacturing is an asset
- Knowledge and understanding of drug product development (liquid and solid dosage forms), manufacturing processes, as well as microbiological quality control, packaging and distribution aspects
- Excellent knowledge of relevant GMP 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 manage complex projects and prioritize workloads according to the project importance
- 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 is an asset

**What Idorsia offers**
- Exciting opportunities for development and professional growth within our dynamic organization
- A collaborative and solution oriented enviroment 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
**Country**: Switzerland
**Business Area**: Quality Assurance
**Schedule**: Fulltime

**Job Type**: Permanent
**Job Id** : 3469

**_At Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success._**
**_We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees._

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