Zehra Akerman Email & Phone Number

Limassol, Cyprus

- Providing consulting on quality-related matters to clients.- Preparing and reviewing regulatory documents such as process validation (CPV) and PQR reports for a client.

Birmingham, England, United Kingdom

Responsibilities:- Assisting in pricing and budgeting,- Liaison with clients and computational analysts: - Gather and document customer feedback and collaborate with data analyst, - Make sure issues are resolved in a timely manner and clients are satisfied,- Help with visualisation and the final quality controls on the results and their communication to the client,- Examine local university directories to find researchers who might be interested in Mirex’s services and make first contact,- Meet with clients to explain the expertise of the partnership,- Complete necessary forms for billing.

Cyprus

- Organized, coordinated, and executed all aspects of the company's process validation activities, ensuring compliance with up-to-date GMP regulations. Supervised, oversaw and reviewed the work of four validation scientists.- Prepared, reviewed and approved high-level regulatory documents for over 300 pharmaceutical products, ensuring timely submissions to health authorities for marketing authorisations across more than 100 countries and to clients.- Ensured inspection and audit readiness at all times, successfully representing the team during these on-site visits with no major comments. This includes inspections conducted by UNICEF, MSF, ICRC, Ministries of Health of Brazil and Japan, and audits performed by Sandoz, Sanofi, Mylan, and Cobalt-Canada.- Authored, reviewed and approved risk-based, scientifically sound process validation strategies, master plans, protocols, reports, and other process validation documents by taking into account regulatory requirements and in-house policies.- Authored, revised, and approved SOPs, providing clear instructions to individuals across different departments.- Authored and implemented the risk management procedure and statistical analysis in the team. - Reviewed change requests and deviations, systematically assessing potential impacts on product quality through comprehensive risk assessments, and determined the action plan.- Participated in managing CAPA and quality complaints, collaborating closely with Quality Assurance team members to ensure effective resolutions and quality enhancements.- Handled communications in writing and orally with regulatory authorities and clients resolving inquires promptly.- Coordinated with cross-functional teams, both internally and externally, to ensure the smooth execution of validation projects. - Maintained meticulous documentation and managed multiple databases and document management systems, ensuring accurate record-keeping, archiving and regulatory compliance.

Liverpool, United Kingdom

Projects and Responsibilities:- The general running of the laboratory, organisation, maintenance of records such as liquid nitrogen stock list, glycerol stock list, DNA plasmid list and full responsibility for cell culture- Investigating the role of the endosomal DUBs, UBPY and AMSH in EGFR signalling;- Creating EGFP tagged DUBs by employing gateway system to ultimately analyse the localisation of DUBs in the human cells

Master'S Degree, Human Genetics

Bachelor'S Degree, Biology