For one of our clients, an international pharma company in Kaiseraugst, we are looking for a Compliance Expert.
As a compliance expert, you and your colleagues ensure that the relevant GMP requirements are implemented. You are the contact person for initiating, coordinating and implementing all necessary measures to achieve and maintain GMP compliance. To this end, the compliance expert has a key technical function in GMP matters for all personnel in the value stream.
General information:
- Start date: ASAP / 02.01.2025
- Latest possible start date: 01.03.2025
- Planned duration of employment: 1 year
- Extension: To be decided on a case-by-case basis
- Workplace: Kaiseraugst
- Workload: 100%
- Home office: approx. 20%
- Travel: No
- Team: approx. 15
- Working hours: Standard
- This position is in a GMP relevant environment
Tasks & responsibilities:
- Carrying out checks for completeness and accuracy of the entries in the batch record, passing on the batch record documentation to QA after completion of all relevant activities.
- Responsible for compliance issues in the value stream such as Quality Risk Management, SPOC Inspection Management, Documentation Expertise, PQS
- Responsibility for processing deviations (DMS), technical changes (TCM) or CAPAs, GMP training and managing higher-level GMP projects across value streams
- Willingness to work in a self-organized team with a high degree of personal responsibility in an open and collaborative environment.
- Drive LPS methods and tools forward together with the team and live them in day-to-day business. Contribute ideas to improve quality, efficiency of systems, cost reduction and processes.
- Close cooperation with value stream internal and external interfaces to achieve ambitious goals for lead time, quality, commitment and costs.
- Induction and taking on new activities in neighboring areas and/or value streams in the sense of polyvalent further development.
- Compliance with all safety and environmental regulations, as well as conscious promotion of operational safety
Must Haves:
- Completed vocational training or a completed Bachelor's/Master's degree, ideally in the field of pharmaceutical manufacturing or a related field
- At least 3 years of professional experience in pharmaceutical production, development, quality assurance or control
- Experience in a GMP-regulated environment
- Experience in batch record review, in a sterile filling area (pharmaceuticals)/aseptic activities is an advantage
- Quick comprehension and great interest in technical processes as well as affinity for dealing with IT systems
- Very good written and spoken communication skills in German and good knowledge of English
- Great willingness and curiosity to develop flexibly and to learn across departments in the spirit of versatility. This includes an interest in understanding and getting to know upstream and downstream process steps.
- A team-oriented mindset with a view to constantly improving processes and the ability to deliver consistent performance at a high level in a constantly changing environment.
- Knowledge and commitment to process improvements (e.g. Lean Production System) as well as agile management or microbiological knowledge are an advantage.
- Ability and openness to recognize and live the opportunities and advantages of change. In this sense, an interest in the areas of coaching and change management is an advantage.
- High ability to work in a team and solution-oriented as well as collaborative working methods.
- Routine handling of IT systems (e.g. Google applications and Veeva)
For one of our clients, an international pharma company in Kaiseraugst, we are looking for a Compliance Expert.
As a compliance expert, you and your colleagues ensure that the relevant GMP requirements are implemented. You are the contact person for initiating, coordinating and implementing all necessary measures to achieve and maintain GMP compliance. To this end, the compliance expert has a key technical function in GMP matters for all personnel in the value stream.
General information:
- Start date: ASAP / 02.01.2025
- Latest possible start date: 01.03.2025
- Planned duration of employment: 1 year
- Extension: To be decided on a case-by-case basis
- Workplace: Kaiseraugst
- Workload: 100%
- Home office: approx. 20%
- Travel: No
- Team: approx. 15
- Working hours: Standard
- This position is in a GMP relevant environment
Tasks & responsibilities:
- Carrying out checks for completeness and accuracy of the entries in the batch record, passing on the batch record documentation to QA after completion of all relevant activities.
- Responsible for compliance issues in the value stream such as Quality Risk Management, SPOC Inspection Management, Documentation Expertise, PQS
- Responsibility for processing deviations (DMS), technical changes (TCM) or CAPAs, GMP training and managing higher-level GMP projects across value streams
- Willingness to work in a self-organized team with a high degree of personal responsibility in an open and collaborative environment.
- Drive LPS methods and tools forward together with the team and live them in day-to-day business. Contribute ideas to improve quality, efficiency of systems, cost reduction and processes.
- Close cooperation with value stream internal and external interfaces to achieve ambitious goals for lead time, quality, commitment and costs.
- Induction and taking on new activities in neighboring areas and/or value streams in the sense of polyvalent further development.
- Compliance with all safety and environmental regulations, as well as conscious promotion of operational safety
Must Haves:
- Completed vocational training or a completed Bachelor's/Master's degree, ideally in the field of pharmaceutical manufacturing or a related field
- At least 3 years of professional experience in pharmaceutical production, development, quality assurance or control
- Experience in a GMP-regulated environment
- Experience in batch record review, in a sterile filling area (pharmaceuticals)/aseptic activities is an advantage
- Quick comprehension and great interest in technical processes as well as affinity for dealing with IT systems
- Very good written and spoken communication skills in German and good knowledge of English
- Great willingness and curiosity to develop flexibly and to learn across departments in the spirit of versatility. This includes an interest in understanding and getting to know upstream and downstream process steps.
- A team-oriented mindset with a view to constantly improving processes and the ability to deliver consistent performance at a high level in a constantly changing environment.
- Knowledge and commitment to process improvements (e.g. Lean Production System) as well as agile management or microbiological knowledge are an advantage.
- Ability and openness to recognize and live the opportunities and advantages of change. In this sense, an interest in the areas of coaching and change management is an advantage.
- High ability to work in a team and solution-oriented as well as collaborative working methods.
- Routine handling of IT systems (e.g. Google applications and Veeva)
