RESPONSIBLE PERSON / QUALITY SYSTEMS SENIOR SPECIALIST

Job Description

• Serving as a crucial stakeholder in managing and executing assigned Quality System processes and/or programs such as change control, internal audit programs, LIMS administration, vendor & supplier qualification, and other QS-related tasks.
• Acting as a key interface for client and authority inspections, ensuring preparedness, readiness, and follow-ups post-audit.
• Ensuring proper distribution practices to protect product users, including adherence to GDP regulations and best practices in all regulated activities. Additionally, maintaining a compliant quality system, including a document control system, for adequate record management.
• Leading and supporting action plans and risk assessments related to potential nitrosamine contamination in various products.
• Representing Quality Systems in Project Leadership Teams for new product introduction.
• Performing and managing Responsible Person (RP) duties for controlled drugs on-site.

The ideal candidate should have:

• A tertiary level education in life sciences or a related field, with preference for candidates with a pharmacy degree.
• 2-3 years of relevant experience in quality and/or systems within the pharmaceutical sector preferred.
• Excellent communication skills and fluency in written and spoken English are necessary.
• Ability to analyze and troubleshoot problems, identify solutions, and implement methods, procedures, and techniques for resolution.
• Attention to detail is crucial, along with the ability to work independently and as part of a team.

Additional information:

• Reports to the Quality Systems & Compliance Manager
• Package includes basic pay, performance bonus, health insurance, and other benefits.