Responsible Person (RP / FvP) (a) 100%

Bachem is seeking an experienced Responsible Person (RP / Fachtechnisch verantwortliche Person, FvP) to provide independent technical and GMP oversight for activities covered by the Swiss establishment licence. The role combines regulatory accountability, sound quality judgement and senior interaction with authorities, customers and internal stakeholders.

Your responsibilities:

• Act as the designated RP/FvP for the assigned activities under Bachem’s Swiss establishment licence and ensure effective technical supervision.

• Provide independent oversight of applicable manufacturing, testing, batch disposition, storage and distribution activities in accordance with Swiss GMP/GDP requirements and Bachem’s Pharmaceutical Quality System.

• Make or support independent quality and regulatory decisions for significant deviations, investigations, CAPAs, changes, product-quality defects and other critical quality events.

• Ensure appropriate escalation and measures where product quality, patient safety or regulatory compliance may be affected, including quarantine, supply restrictions, withdrawal or recall where required.

• Support inspections, establishment-licence activities and required communication with stakeholder and other health authorities 

• Represent Quality in customer audits, quality meetings and critical product or supply discussions while maintaining the independence of the RP/FvP function.

• Contribute to key quality governance processes and promote a strong, riskbased quality culture.

Your profile:

• University degree in pharmacy, chemistry or another relevant scientific discipline, with education, technical knowledge and relevant professional experience and suitability for the authorised activities
• Substantial experience in pharmaceutical, biotechnology or API manufacturing and strong knowledge of GMP/GDP, Swiss pharmaceutical legislation and relevant EU GMP and ICH expectations.

• Demonstrated experience in batch disposition, deviations, investigations, CAPA, change control, complaints, product-quality defects and recalls.

• Strong scientific judgement, integrity, trustworthiness and the ability to take independent, well-founded decisions.

• Ability to ensure direct technical supervision through an appropriate level of availability, on-site presence and workload for the approved scope.

• Clear communication and confidence in interactions with authorities, customers and senior stakeholders.

• Trustworthiness and independence in exercising the RP/FvP function

• Strong German and English language skills are essential
  
  

Our offer:

• A dynamic and rapidly growing work environment with internal development opportunities
• Employee development through numerous internal and external training opportunities
• 60% coverage of pension fund contributions by Bachem AG as well as option for extra-mandatory pension provision with our Pension Plan Plus
• Access to the benefits platforms with discounts from external partners
• Fresh, healthy and varied food in our staff restaurant 
• A wide range of free sports activities on the Bachem Campus

Would you like to drive innovation together with us?

Have we aroused your interest? Then we look forward to receiving your complete application documents via our application portal.

Learn more about the Bachem Group and be inspired by our inspiring working environment at our location in Bubendorf!