QA Manager

About The Role

Win Medica Pharmaceutical SA is currently seeking for a motivated QA Manager for our High Potent facility in Tripoli Greece.

The QA Manager will be responsible for overseeing all QA functions, ensuring that the quality system is developed and implemented in line with applicable GMP standards, regulations and company’s quality policy and objectives in order the products to be of the quality required for their intended use.

Responsibilities – Duties

• Responsible for the implementation of the Quality System in the company.
• Coordinates, Monitors, Checks and Assures the smooth, timely and effective operation of QA department.
• Develops & Checks all quality documentation (such as policies, SOPs, etc.) of the factory to be in line with the Quality Policy of the company, the applicable GMP standards, regulations (EMA, FDA), pharmacopoeias, product’s file and customer’s requirements.
• Responsible for the review and continual improvement of the Quality system by monitoring and evaluating the internal trends (through quality metrics, internal audits, daily checking & findings, etc.) and the updates/changes of applicable GMP standards, guidelines, regulations, and pharmacopoeias requirements.
• Leads and ensures timely and effective handling of all quality operations, quality plans (such as validation, personnel training, internal and external audits, etc.) and issues such as recalls, mock recalls, complaints, investigations, CAPAs, risk evaluation, changes, deviations, etc.
• Coordinates the Quality metrics & PQRs, monitors their trends and proposes corrective actions.
• Participates in customer audits and inspections by health authorities, coordinates their preparation, the back-office, the timely, and efficiently closing of the corrective actions.
• Supervises and ensures that each individual batch has produced in compliance with the applicable Quality system and all required checks and tests have properly implemented in order the product to be released and certified by the QP for sale. 
• Coordinates and ensures that all requested data related to quality is provided in a timely manner to external requesters (authorities, customers, suppliers, external service providers, etc.) as well as to internal requesters (other departments in the factory and corporate departments).

Qualifications

Education & Experience:

• Bachelor's degree in life sciences, pharmacy, chemistry, engineering, or a related field.
• Excellent communication in English language both written and oral.
• Excellent Knowledge of MS Office ( Word, Excel, Power Point).
• Knowledge and understanding of regulatory requirements, Good Manufacturing Practices (GMP), quality standards and legislation in the pharmaceutical industry.
• Minimum of 5 years' experience in a Quality Assurance department within the Pharmaceutical Industry.
• Experience in drafting SOPs, protocols, reports.
• Experience as QA Manager, QA Supervisor or as Team leader will be taken under consideration.
• Experience in regulatory inspections and audits from health authorities and customers.

Skills & Others:

• Strong communication, organization and people management skills.
• Time management.
• Organizational skills.
• Writing skills (drafting SOPs, protocols, reports).
• Meet the conditions for appointment as QP.
• Knowledge and understanding of quality management system.
• Knowledge and understanding of risk management and statistical evaluation.
• High ethical standards and commitment to assurance of product quality and patient safety.