Key Responsibilities:

• Participates in the activities of the Responsible Pharmacist in distribution and acts as a substitute in case of absence.
• Organizes and participates in the distribution of manufacturing documentation (batch records) to Production.
• Participates in nitrosamine risk assessments in products.
• Participates in the preparation and revision of Quality Agreements.
• Participates in internal audits of the Quality Management System within the organization.
• Participates in inspections conducted by regulatory authorities, certification bodies, and partners.
• Participates in the performance of external audits of contracted service providers, manufacturers of starting materials (bulk materials, packaging materials), and other service providers.
• Participates in the preparation of risk analyses within the scope of responsibility to ensure that risks are adequately controlled in accordance with company and regulatory requirements (EU GMP, ISO) and internal procedures.
• Participates in the preparation of GAP analyses during the implementation of new or amended regulatory requirements/guidelines.
• Participates in the management of market and customer complaints, including investigation, resolution, and preparation of relevant reports and responses to customers.
• Provides support in the management of CAPA and non-conformities.
• Participates in the drafting of Standard Operating Procedures (SOPs) and coordinates their approval process through the eDMS.
• Prepares weekly, monthly, and quarterly Quality reports.
• Monitors changes in regulatory requirements (GMP, GLP, GDP, ISO standards, etc.), as well as applicable legislation and quality standards related to the manufacturing and distribution of medicinal products, medical devices, and dietary supplements.

Requirements:

• University degree, Master of Pharmacy.
• Minimum 3 years of relevant work experience in QA in pharmaceutical industry.
• Computer literacy, experience with working in QA applications and databases
• Sound knowledge of National and EU GMP regulations, legal regulations for pharmaceutical industry.
• Fluency in English.

Candidates profile:

• Good interpersonal and presentation skills.
• Good written and verbal communication skills.
• Ability to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful way.
• Analytical skills and good judgment.