Ausra Ziemeliene

Regulatory Affairs Officer with 6 years of experience in Module 1 and serialisation, and more than 10 years of experience in quality control. Experienced in communication with project managers, manufacturers and the MHRA regarding submissions to ensure all requirements are met. Combines strong regulatory, compliance, and quality control knowledge to enhance regulatory and quality interactions.

Works independently on delegated projects and collaborates as a member of the support team to ensure efficient management of pharmaceutical operations.

Regulatory Affairs Executive at Maxearn/Quadrant Pharmaceuticals Ltd (2026-01 – 2026-06)

• New PLPI License Applications and renewals.
• Preparation and submission of PLPI Variations
• Create and manage Change Controls.
• License account and item creation and monitoring in Dynamics.
• Artwork review, update, and implementation.
• Samples linkage review.

Regulatory Affairs Officer at Waymade PLC (2019-04 – 2025-04)

Responsible for the effective management of the projects of the generic medicines for the UK, EU, Australia, Canada, UAE, Saudi Arabia, EEU, and African countries with a focus on Module 1: SPC, PIL, labelling text and mock-ups update in line with the safety, reference product and manufacturer requirements.

• Submit variations: IA, IAIN, II, notification 61(3).
• Post-approval: administrative activity, communication with manufacturers, and the updated artwork implementation (approval for printing, serialisation information, etc.).
• Master Data creation and publishing.
• Collaboration with colleagues and third-party organisations.
• Advise internal teams, business partners, and managers on regulatory strategy, requirements and progress.
• Perform periodic reviews of MA's (Sunset Clause), GMP and GDP non-compliance reports, and Suspended and Revoked reports.

Quality controller at Noble Recruiting (2018-10 – 2019-03)

Responsible for the quality control assurance during production and the finished product inspection.

• Sample collection and inspection during the entire production process, quality document filing, and dealing with issues related to production.

Quality controller at R.B.F. Healthcare Ltd. (2016-11 – 2018-10)

• Full assembly of a health device and quality inspection.
• Managing customer orders, with a focus on priority setting, dispatch dates and label collection.
• Led quality control efforts for finished products by checking, testing, replacing and labelling specific items.
• Filled product control documentation and oversaw assembly at all stages of production.
• Working effectively without supervision, as well as closely with a wider team.

Quality & Laboratory Manager at Eckes-Granini, Lithuania (2002-07 – 2012-09)

Responsible for the laboratory operation and administration.

• HACCP, GMP and IFS (International Food Standard) Systems implementation and supervision.
• SOPs, specifications and forms creation and implementation according to the business and production needs.
• Raw materials and final products quality control: identifying non-conformities, foreign bodies, collecting, testing and storing product samples.
• Filling lines, devices, and equipment hygiene supervision and monitoring in line with GMP requirements.
• Warehouse supervision and monitoring in line with the GMP and GDP requirements.
• Final product release to the market.

Master's degree in Pharmaceutical Sciences – Anglia Ruskin University (2023-09 – 2025-09)

Professional Studies certificate in Quality Assurance in the Pharmaceutical Industry – The University of South Wales (2017-09 – 2019-03)

Bachelor's degree in Ecologist – Lithuanian University of Agriculture (1998-09 – 2002-06)

Professional studies certificate in Management and Business Course – Vilnius University (2008-09 – 2009-05)