Degree in scientific disciplines (preferably in chemistry and pharmaceutical technologies, chemistry, pharmacy, biological sciences or biotechnology) and/or in engineering
At least 3 years' experience in the QA role, gained in pharmaceutical companies
Good relational, organizational (problem-solving) and analytical skills
Good knowledge of the main computer applications
Good technical and regulatory preparation (GMP, GDP, ISO 9001, ISO 13485)
Good knowledge of spoken and written English
Responsibilities
Ensure an adequate and efficient Quality System (QMS) and adequate state of validation of equipment, systems and processes in compliance with company requirements, in collaboration with the QA Manager
Operate in compliance with company quality standards, through the application of procedures relating to areas of competence, in compliance with company quality policies and procedures
Manage non-conformities/deviations and CAPA
Manage deadlines and carry out quality planning
Collect, analyze and produce reports relating to product, process and performance results
Implement a culture of quality and data integrity through continuous interaction with other company functions in daily activities
Conduct and coordinate validation projects, either directly or with the support of external consultants, and manage all project documentation in line with regulatory expectations
Verify the conformity of the activities of products and processes, and validation
Draft, update and manage risk assessment, commissioning, qualification and validation documents, technical documentation (drawings, lists, schemes) following established standards and models
Ensure accurate records of all validation activities
Maintain validation documentation throughout the validation lifecycle
Identify training needs, plan and execute training interventions related to projects and validation activities
Ensure the updating of the SOPs under its responsibility
Support the evaluation processes of external service providers through qualification, audits, dynamic evaluation
Assist in managing activities required by Ecolab for project issues
Support company functions in identifying and implementing actions to optimize and improve the quality of processes, systems and equipment
Operate in compliance with personal and environmental safety regulations