Reyndur sérfræðingur í gæðamálum samsettra lyfja og tækjaafurða / Combination Products & Device

Alvotech leitar að reynslumiklum sérfræðingi til að taka þátt í þróun og gæðaeftirliti samsettra vara og spraututækja. Í þessu hlutverki verður viðkomandi lykilaðili innan Pharmaceutical Sciences Quality og tryggir faglegt gæðastarf yfir allt hönnunar og þróunarferlið, alveg frá hugmynd til markaðssetningar.

About the position:

Alvotech is looking for a new member to join Pharmaceutical Sciences Quality department (PSQ). PSQ is a function within Alvotech Quality focused on quality oversight and support of design control development and validation activities across the entire combination product development lifecycle. This position is an R&D Quality compliance SME responsible in all phases of the device design control process from concept/feasibility/planning through commercial product lifecycle management.

Potential candidates for this role understand the need for, and application of phase appropriate cGMP design control across the product development lifecycle within the R&D, Quality Management System (QMS), with a specific focus on injectable biosimilar Combination Products and Devices.

Responsibilities

• Execute QA review and approval of various quality related documents generated by CPD R&D during all stages of device design control (DHF, risk management files, and other associated documentation) in a 21 CFR Part 820/ISO 13485 compliant QMS.

• Collaborate with R&D partners in daily compliance activities and coach in executing quality related procedures.

• Contribute to, author, review and approve procedures, and other supporting documents related to CPD processes.

• Contribute as required in design, deployment, and improvements of the phase appropriate Quality Management System (QMS).

• Routinely leads cross functional projects and performs variety of tasks of variable complexity.

• Contribute as required in internal and health authority inspections and any other interactions with regulatory agencies.

• Independent Quality projects as assigned

Requirements

• Minimum 5 -10 years' experience in a quality assurance function supporting devices and /or combination products

• Bachelor‘s/Master‘s degree in chemistry, biochemistry, biotechnology or equivalent.

• Proficient in Quality system processes such as CAPA, Change controls, Investigations, and document management, etc.

• Knowledge of physical device testing and characterization methods.

• Knowledge of physiochemical/bioanalytical methods is a plus

• Thorough understanding of regulatory GxP requirements

• Experience in supporting regulatory audits including FDA and EMA is highly desirable.

• Experience working in a regulated pharmaceutical environment is highly desirable

• Experience in using a validated eDMS is an advantage.

• Ability to work independently with minimal supervision