EMPREGO REGULATORY COMPLIANCE ENGINEER LOURES, LISBOA

Takes lead on non-complex projects / campaigns (with guidance) and supports the lead process engineer in complex projects / campaigns... join a market leader...

Review regulatory documentation and co-ordination of site documentation to support regulatory requirements... guarantees cgmp compliance in all activities and systems...

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

Prepare protocols, reports, qc documentation and review records to ensure compliance with cgmp and hsee standards... perform periodic checks of laboratory documentation...

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...

Manage and control all quality control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract...

Recommends the analytical characterization package (chemical, physical, performance) and controls the quality and accuracy of the data in compliance with legislation...

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