Engineer, Validation

Description

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 1000 employees and 3 factories for the production of injectable medicines.

Hikma, intends to recruit an Engineer, Validation (m/f) to integrate Quality Department, on\-site work.

Main Responsibilities:

• Operates instrumentation and assists in protocol execution/performs validation activities


• Calibrates critical processes instruments and equipment, and drafts and prepares documents on calibration that fulfil validation requirements in relevant protocols: performs calibration work


• Performs data analysis and prepares written reports/summaries from validation studies


• Ensures execution and documentation of internal and external scheduled validation field activities


• Writes/reviews department applicable Standard Operation Procedures (SOPs)


• Liaises with external validation contractors, ensuring conformance of activities to procedures and processes


• Support the management in critical documents and CAP


• Stays updated with regulatory and quality standards, evolutions in GXP compliance and best practices where needed


• Schedules in coordination with Other departments and Validation supervisor, equipment times, prepares test equipment and assures thar testing is completed according to approved validation protocols. Verifies calibration work performed by others


• Suports audit preparation at side

Profile:

• Academic degree in Science


• Minimum of 1 year of professional experience or training in a QA related area;


• Ability to handle a multi\-task operation, to meet tight deadlines and to work under pressure


• Should be assertive, flexible, and attentive to detail


• Fluency in English and good computer skills are preferred


• Knowledge regarding the Injectables pharmaceutical industry, current Good Manufacturing Practices (GMPs), Food and Drug Administration (FDA) and other regulatory authority requirements (preferred, non mandatory)

We offer:

• + Direct contract with Hikma

+ Competitive salary aligned with the role
+ Life insurance
+ Health Insurance extended to student children (up to age 24\)
+ Annual Performance Bonus
+ Real Growth Opportunities

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

Location:
Sintra, Sintra, PT

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