Responsible Person / Quality Systems Senior Specialist

About the role

The role is a key stakeholder in managing quality system processes, ensuring compliance with regulations and supporting product introductions. It involves interfacing with clients, authorities and internal teams to maintain a robust quality environment.

Key responsibilities

• Manage and execute quality system processes such as change control, internal audits, LIMS administration, and vendor/supplier qualification.
• Act as the main interface for client and authority inspections, ensuring preparedness and follow‑up.
• Maintain distribution practices in line with GDP regulations and oversee document control for record management.
• Lead action plans and risk assessments related to nitrosamine contamination.
• Represent Quality Systems in Project Leadership Teams for new product introductions.
• Perform Responsible Person duties for controlled drugs on‑site.

Required profile

• Tertiary education in life sciences or related field, preferably a pharmacy degree.
• 2‑3 years of quality or systems experience in the pharmaceutical sector.
• Excellent written and spoken English communication skills.
• Strong analytical ability to troubleshoot problems and implement solutions.
• High attention to detail and ability to work both independently and in a team.

Required skills

• Change control management
• Internal audit program execution
• LIMS administration
• Vendor and supplier qualification
• Good Distribution Practice (GDP) compliance
• Document control systems
• Risk assessment and mitigation (nitrosamine focus)
• Responsible Person (RP) duties for controlled drugs

What we offer

• Basic salary plus performance bonus
• Health insurance
• Additional benefits