Engineer, Validation

Sintra, Lisboa
Permanente
Horário completo

Há 6 dias

Founded by Samih Darwazah over 40 years ago in Jordan, Hikma's purpose is to provide affordable, quality medicines to the people who are competent. Based on very solid foundations, we continue to innovate daily and find practical solutions to transform the lives of the millions of people we serve.At the end of the 1980s, we extended ours beyond the Middle East and acquired land in Portugal for the construction of a sterile factory for injectable pharmaceutical products. This was an important turning point for the company, and our first step into a new region. Today, in Portugal, we have more than 900 employees and 3 factories for the production of injectable medicines.Hikma, intends to recruit an Engineer, Validation (m/f) to integrate Validation Inspection Department, on-site work.Main Responsibilities:

Operates instrumentation needed for particles identification and test sets preparation
Prepares 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
Verifies results and coordinates inspectors' qualification
Manage the particles Library and keep it updated, reflecting new lines and new materials
Operates instrumentation needed for calibration and testing of critical processes instruments and equipment
Drafts and prepares documents on protocol execution/performs validation activities
Performs data analysis and prepares 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
Ensures execution and documentation of internal and external scheduled validation field activities
Writes /reviews department applicable Standard Operating Procedures (SOPs)
Liaises with external validation contractors, ensuring conformance of activities to procedures and processes
Schedules in coordination with Other departments and Validation manager, equipment times, prepares test equipment and assures that testing is completed according to approved validation protocols
Stays updated with regulatory and quality standards, evolutions in GXP compliance and best practices where needed, for supporting audit preparation at site

Profile:

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
Demonstrates proactivity

We offer:

Direct contract with Hikma
Salary appropriate to the functions performed
Life insurance
Health insurance
Annual Performance Bonus
High career prospects

If you think this is a good opportunity for your professional career, join us and contribute to Better Health, within everyone's reach, every dayLocation:Sintra, Sintra, PT

Hikma Pharmaceuticals

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