QA Compliance Manager (GMP/GDP) Manufacturing Facilities and QC Laboratories

Location: 

Basel City, BS, CH

 

 

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


Job 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


Candidate’s Requirements

 

  • 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 encourage all potential candidates with diverse backgrounds of race, color, religion, sexual orientation, gender identity, age, national origin, and disability to submit their job applications. All applicants will receive consideration.
We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees.

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.