EMPREGO SENIOR REGULATORY COMPLIANCE PRODUCT LOURES, LISBOA

Familiarity with regulatory compliance procedures, publications and an ability to interpret relevant legislation... advanced knowledge of compliance needs in hse...

Ensure compliance with gmp internal and external requirements as well as promote the implementation and maintenance of hovione´s policies, systems and procedures...

Review regulatory documentation and co-ordination of site documentation to support regulatory requirements... approves iops, process master documentation and product...

Assure product specifications are maintained in accordance with appropriate standards and propose revisions as required... prepare protocols, reports, qc documentation...

Performs qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product... promotes the scientific excellence...

Manage qualification and validation (q&v) procedures to ensure that are updated as per the latest regulatory guidance and industry best practices... propose qualification/validation...