At Hikma Pharmaceuticals, we are committed to providing affordable quality medicines to the people who need them. Our purpose is to innovate daily and find practical solutions to transform the lives of the millions of people we serve.
We have a rich history dating back over 40 years, starting in Jordan and expanding to new regions including Portugal. Today, we have more than 900 employees in Portugal working across three factories producing injectable medicines.
We are seeking an Engineer to join our team in Sintra, Portugal. As part of our Validation Inspection Department, you will be responsible for ensuring the good condition of all test sets and conducting regular checks.
Main Responsibilities:
* Operate instrumentation needed for particles identification and test sets preparation
* Prepare all test sets needed for inspectors and machines qualification for visible particulate matter and visual defects
* Ensure the good condition of all test sets under Insp. Validation responsibility, conduct regular checks
* Verify results and coordinate inspectors' qualification
* Manage the particles Library and keep it updated, reflecting new lines and new materials
* Operate instrumentation needed for calibration and testing of critical processes instruments and equipment
* Draft and prepare documents on protocol execution/performs validation activities
* Perform data analysis and prepare written reports/summaries from validation studies, including Limit reports, from historical data, for rejection rates due to particles
* Support the management in critical documents, CAPA acting as CAPA owner
* Ensure execution and documentation of internal and external scheduled validation field activities
* Write/review department applicable Standard Operating Procedures (SOPs)
* Liaise with external validation contractors, ensuring conformance of activities to procedures and processes
* Schedule in coordination with Other departments and Validation manager, equipment times, prepare test equipment and assure that testing is completed according to approved validation protocols
* Stay updated with regulatory and quality standards, evolutions in GXP compliance and best practices where needed, for supporting audit preparation at site
Requirements:
* Bachelor's degree or equivalent in Technical / Science
* Demonstrated computer skills including Word, Excel and CAD
* English Intermediate Level
* Ability to work as part of a team
* Good analytical and organizational skills and should have the ability to think critically
* Demonstrate proactivity