QUALITY ASSURANCE MANAGER - PHARMACEUTICAL INDUSTRY

- University degree in Chemistry, Biochemistry, Pharmacy, or other related fields;
- Experience in a similar position for a minimum of 3 years in Pharma;
- Extensive knowledge of GMP;
- Knowledge of current Pharmaceutical Quality System standards and ISO standards;
- Advanced level of English- writing and speaking;
- Qualified person certificate;
- Excellent planning, organisational, communication and interpersonal skills;
- Attention to detail;
- Analytical thinking;
- Strong task management skills with the ability to prioritize, schedule, and control multiple projects and resources simultaneously;
- Excellent communication skills, including excellent written, interpersonal, collaboration, with a team-oriented approach;
independent, proactive, and precise in the performance of assigned tasks;
7- Good MS Office skills - Excel, Word, Outlook.

- Implements, maintains and improves the Quality Management System integrated in the company according to the GMP Guidelines for Veterinary/Human Medicinal Products and ISO standards in force;
- Participates in the elaboration of the documentation of the Integrated Management System at company level and elaborates specific procedures for quality assurance activities.
- Coordinates the initial and periodic training of personnel on GMP provisions and ISO standards;
- Coordinate internal/external audits within the company carried out by customers/authorities and ensure the follow-up of the implementation of corrective actions to remove quality non-conformities found during audits;
- Review, analyse and manage deviations and complaints keeping records of them, following up the resolution of out of specification results;
- Participates in validation/revalidation, qualification/recertification protocols and reports and identifies specific issues and possible trends to be included in the annual quality management system assessment report;
- Ensure compliance with specifications requested by customers;
- Represents the company in relations with third parties in matters relating to the quality of manufactured products;
- Completion of manufacturing documents for the purpose of tracking the entire history of a manufacturing series;
- Management of the product nomenclature, keeping up to date the authorisations and approvals in the field of drug distribution;
- Propose actions to improve processes/activities/quality of products/documents, as appropriate;
- Responsible for the accuracy and legality of documents issued at department level.